Reported trial results for Obesity
Every Obesity trial Voxsanity tracks that has reported results to a public registry, newest first. These trials have finished, so they are not recruiting. Not medical advice.
84 trials have reported results.
AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
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NCT03226821 · results posted 19 May 2026
According to the results reported on ClinicalTrials.gov, six people took part in this trial, all of whom received the study drug tesamorelin. The trial was measuring several things in the body, including the amount of fat stored in the liver (called hepatic lipid content), the amount of fat stored deep in the abdomen around the organs (called visceral adipose tissue), activity of certain genes in fat tissue, and resting energy use. Notably, none of the six participants were recorded as having completed the study — all six did not finish. The reported data shows three figures for liver fat content (measured as a percentage of liver volume): 7%, 3.58%, and 1.09%. For deep abdominal fat (measured in kilograms), three figures were also reported: 6.7 kg, 5.9 kg, and 3.6 kg. It is not clear from the submitted data whether these figures represent different time points (for example, before, during, and after treatment) or something else, as that detail was not specified in the results as filed. For the remaining secondary outcomes — gene activity measures and resting energy use — no numerical data was reported to ClinicalTrials.gov. Because no participants completed the trial, and because several outcome measures were left without data, the results as submitted are limited. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT04007393 · results posted 5 May 2026
According to the results reported on ClinicalTrials.gov, this trial (NCT04007393) enrolled 150 participants in total across eight groups. The trial was comparing different combinations of a lifestyle and medical treatment programme — referred to as "LSMT" — run over either 12 or 24 weeks, with some groups also receiving the medications phentermine and/or topiramate, and others receiving a placebo (a dummy treatment with no active ingredient). The main thing the trial was measuring was the percentage change in BMI (Body Mass Index, a number calculated from a person's height and weight) from the start of the trial to week 48. The reported data shows the following percentage changes in BMI by week 48 for each group. In the 12-week programme groups: the lifestyle programme alone showed a change of −9.62%, the programme plus phentermine showed −12.27%, the programme plus both phentermine and topiramate showed −4.53%, and the programme plus topiramate and placebo showed −2.53%. In the 24-week programme groups: the lifestyle programme alone showed −12.36%, the programme plus phentermine showed −9.52%, the programme plus both phentermine and topiramate showed −3.45%, and the programme plus topiramate and placebo showed −0.30%. A negative number here means BMI went down on average in that group. No secondary outcome measures were included in the data provided, so those figures cannot be described here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT06034457 · results posted 19 December 2025
According to the results reported on ClinicalTrials.gov, this trial enrolled 180 people in a single group — meaning everyone received the same program, and there was no comparison group. The study looked at a combined behavioural weight-management program (WW, including its clinic-based medication support service, formerly known as Sequence) over 24 weeks. Of the 180 people who started, 166 completed the study and 14 did not finish. The reported data shows that, on average, participants lost 27.41 pounds over the 24 weeks. In terms of how many people reached certain milestones, the data reports that 161 participants lost at least 5% of their starting body weight, 121 lost at least 10%, 81 lost at least 15%, and 20 lost at least 20%. The reported data also shows average changes in blood pressure: systolic pressure (the top number) changed by −11.17 mmHg and diastolic pressure (the bottom number) by −5.66 mmHg from the start to week 24. On a quality-of-life questionnaire (where lower scores mean less impact of weight on daily life), participants' overall scores dropped by an average of 20.13 points, suggesting a reported shift in how weight affected areas like physical function, self-esteem, and daily activities. A well-being questionnaire score increased by an average of 2.92 points (where higher means better well-being), and scores related to disordered eating patterns showed mixed small changes across different areas measured. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT04291560 · results posted 17 November 2025
According to the results reported on ClinicalTrials.gov, this trial (NCT04291560) enrolled 108 pregnant women — 53 in a programme called "Prenatal Heart Smart" and 55 receiving usual care. All participants who started the trial completed it, with no drop-outs recorded. The study was measuring changes in blood pressure (both the top number, called systolic, and the bottom number, called diastolic) during the later stages of pregnancy — at around 27 weeks (the starting point), 32 weeks, and 37 weeks. It also set out to measure changes in the balance between two parts of the nervous system that influence heart function, using a signal called the Pre-Ejection Period (PEP). The reported data shows the following blood pressure changes from the 27-week starting point. For the top (systolic) blood pressure number at 32 weeks, the Prenatal Heart Smart group's average reading rose by 0.73 mmHg (millimetres of mercury, the standard unit for blood pressure), while the usual care group's average fell by 1.56 mmHg. By 37 weeks, the reported data shows both groups had higher systolic readings than at the start — the Prenatal Heart Smart group by an average of 3.14 mmHg and the usual care group by 6.23 mmHg. For the bottom (diastolic) number, at 32 weeks the Prenatal Heart Smart group rose by an average of 0.41 mmHg compared with 1.42 mmHg in the usual care group. By 37 weeks, the reported increases were 4.52 mmHg and 7.63 mmHg respectively. As for the nervous system balance measurements (PEP), no numerical results were reported in the submitted data for either time point. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT04042467 · results posted 16 October 2025
According to the results reported on ClinicalTrials.gov, this trial (NCT04042467) involved 900 participants split into two groups — 449 in the "Greenlight Plus" group and 451 in the "Greenlight" group. The trial followed young children over two years, tracking their weight-for-length measurements (a way of assessing a child's weight relative to their height) recorded during regular paediatric care visits. Both groups received a version of the Greenlight programme, with one group receiving an enhanced version ("Greenlight Plus"). The reported data shows that children in both groups followed a similar pattern of weight-for-length (measured in kilograms per metre) as they grew over the two-year period. In the Greenlight Plus group, the reported measurements at successive time points were approximately 8.0, 9.3, 10.8, 11.9, 12.7, and 13.1 kg/m. In the Greenlight group, the corresponding figures were approximately 8.0, 9.4, 11.0, 12.0, 12.9, and 13.4 kg/m. These numbers simply reflect how children's weight-for-length changed over time across both groups. The reported data for the secondary outcomes — including BMI z-score (a standardised measure of body mass index compared to peers of the same age and sex), weight-for-length z-score, and rates of overweight and/or obesity — were not reported in the data submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT05616013 · results posted 18 July 2025
According to the results reported on ClinicalTrials.gov, this trial (NCT05616013) enrolled 509 participants across nine different treatment groups. The groups tested various combinations and doses of two drugs — bimagrumab (given by infusion) and semaglutide (an injection) — alongside placebo (dummy treatment) groups, over a period of up to 72 weeks. The trial's main goal was to measure how much participants' body weight changed from their starting weight by week 48. Secondary goals included measuring changes in waist circumference and body fat mass (measured using a special type of body scan called a DXA scan) at weeks 48 and 72. It is worth noting that a sizeable number of participants did not complete the study across all groups. The reported data shows that at week 48, the placebo/bimagrumab switching group had the smallest reported average weight change (a reduction of about 3.3 kg), while the group receiving the higher dose of bimagrumab combined with the higher dose of semaglutide (2.4 mg) had the largest reported average weight reduction of about 17.8 kg. Groups receiving semaglutide alone or bimagrumab alone fell in between these figures. For waist circumference, the reported data shows reductions ranging from around 4.7 cm (placebo/bimagrumab group) up to around 19 cm (higher-dose combination group) at week 48, with similar patterns continuing to week 72. For body fat mass, the reported percentage reductions at week 48 ranged from about 5.5% in the placebo/bimagrumab group up to about 42% in the highest-dose combination group. These figures represent averages calculated using a statistical modelling method across the participants who had measurements available — they do not represent every individual's result. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT04636437 · results posted 2 July 2025
According to the results reported on ClinicalTrials.gov, this trial (NCT04636437) enrolled 147 people living with HIV who were already on treatment — 49 in each of three groups. One group switched to a combination called doravirine (DOR) with TAF/FTC, a second group switched to doravirine with TDF/FTC, and a third group stayed on their existing treatment (an INSTI-based regimen with TAF/FTC). The trial was primarily measuring changes in body weight over 48 weeks, and also tracked waist circumference and blood fat levels (triglycerides) at 24 and 48 weeks. By the end of the study, 39, 45, and 43 participants respectively had completed the trial in each group. The reported data shows the following changes in body weight by week 48: the DOR + TAF/FTC group had an average decrease of about 0.47%, the DOR + TDF/FTC group had an average decrease of about 2.73%, and the group that stayed on their existing treatment had an average decrease of about 1.84%. At the halfway point (week 24), the DOR + TAF/FTC group showed a small average increase of 0.44%, while the DOR + TDF/FTC group showed an average decrease of 2.37%, and the continuation group showed an average decrease of 0.39%. For waist circumference at week 48, the DOR + TAF/FTC group recorded an average increase of 1.70 cm, the DOR + TDF/FTC group an average decrease of 1.51 cm, and the continuation group was virtually unchanged at −0.02 cm. For blood triglyceride levels at week 48, reported changes were small across all groups: +1.23 mg/dL, −7.07 mg/dL, and +0.03 mg/dL respectively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT04851587 · results posted 6 June 2025
According to the results reported on ClinicalTrials.gov, this was a pilot study — meaning it was a small, early-stage trial designed to gather information to help decide whether a larger, more definitive trial should go ahead. It tested a program called the "Empower Intervention." A total of 37 people were enrolled, 33 went on to receive the intervention, and 19 fully completed the study. The trial did not have a single main outcome it was testing; instead, it looked at several descriptive measures such as how engaged participants were, how satisfied they were, and how believable they found the program to be. The reported data shows the following numbers across those descriptive measures. On a session-level engagement questionnaire (scored 0–8, where higher means more engaged), the average reported score was 6.9 out of 8. Of the 33 people who started the intervention, 25 were reported as completing it, defined as attending the final group session. On a satisfaction question (scored 1–4, where higher means more satisfied), the reported average score was 3.7 out of 4. On a questionnaire measuring how credible or reasonable participants found the program (scored 0–10, where higher means more credible), the reported average score was 7.8 out of 10. The enrolment rate — the number of people who signed up and then went on to start treatment — was reported as 33 participants. It is important to note that, as the trial itself states, this was a pilot study and these figures are purely descriptive — they are intended to help researchers plan future research, not to draw firm conclusions about the intervention. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT05136430 · results posted 9 May 2025
According to the results reported on ClinicalTrials.gov, this trial enrolled 55 people in total — 27 in a group that received self-regulation strategies combined with guidance on making larger lifestyle changes (called the SR group), and 28 in a group that received healthy lifestyle education (called the LE group). Nearly all participants finished the trial (25 from the SR group and 27 from the LE group). The trial was measuring things related to quitting smoking and weight change, and was also checking whether the program was feasible to run by tracking how often participants attended their sessions. The reported data shows that, for the main (primary) outcomes, 11 people in the SR group and 13 people in the LE group had stopped smoking for at least 7 days in a row, verified by a biological test, at the main follow-up point. For body weight, the SR group reported an average change of minus 5.3 pounds, while the LE group reported an average change of essentially zero (0.03 pounds). Regarding session attendance, the SR group attended about 85% of their sessions on average, and the LE group attended about 91%. For the secondary (additional) outcomes measured at a later follow-up, 13 participants in each group had stopped smoking for at least 7 days. The reported data shows the average number of cigarettes smoked per day was 1.9 in the SR group and 1.6 in the LE group. Additionally, 24 out of 27 participants in the SR group and 26 out of 28 in the LE group were reported to have cut their daily cigarette count by at least half compared to when the trial started. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT03748342 · results posted 17 April 2025
According to the results reported on ClinicalTrials.gov, this trial (NCT03748342) enrolled 97 participants in total — 48 in the Standard Endotracheal Tube group and 49 in the Second-Generation LMA (a type of airway device that sits in the throat rather than passing into the windpipe) group. All participants who started the trial completed it. The trial was measuring whether patients experienced low oxygen levels (hypoxia) after surgery while recovering in the post-anaesthesia care unit (PACU), as well as tracking changes in blood pressure, heart rate, and oxygen levels in the blood during and after surgery. The reported data shows that for the main outcome — the proportion of participants who had one or more episodes of low oxygen in the recovery room — 54.2% of participants in the Standard Endotracheal Tube group and 34.7% in the Second-Generation LMA group were recorded as having this occur. For the secondary outcomes measuring changes in blood pressure, heart rate, and oxygen levels during surgery, zero events were recorded in both groups. For oxygen levels measured 15 minutes into recovery (T15), the reported data shows 10 participants in each group required supplemental oxygen, while 38 (Endotracheal Tube group) and 39 (LMA group) did not. At 45 minutes into recovery (T45), the data shows 3 participants in the Endotracheal Tube group and 0 in the LMA group in one recorded category, 3 in each group in another, and 42 versus 46 participants respectively in a third category — though the specific labels for these sub-categories were not fully reported in the data provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT03254940 · results posted 10 April 2025
According to the results reported on ClinicalTrials.gov, this trial (NCT03254940) enrolled a total of 537 participants across 32 different study groups. Each group received a different combination of text message-based components aimed at weight management — for example, variations in the type of diet plan, the style of messaging, how often messages were sent, and the kind of feedback provided. The trial was measuring whether these different combinations had any effect on participants' weight, diet quality, and physical activity levels over six months. The reported data shows that for the primary outcome — change in body weight after six months — results varied across the groups for which data was provided. Among the 12 groups with reported figures, weight changes ranged from a slight gain of 0.1 kg in one group to a loss of 3.4 kg in another. It is worth noting that complete outcome data appears to have been reported for only 12 of the 32 groups; figures for the remaining 20 groups were not reported in the submitted data. For the secondary outcome of diet quality — measured using a questionnaire where higher scores mean healthier eating — the reported changes across those same 12 groups ranged from an increase of 0.8 points to 4.4 points on a 13–39 scale. For physical activity, the reported changes in weekly minutes of activity ranged from approximately 89 minutes per week to around 391 minutes per week across those groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT05966870 · results posted 12 February 2025
According to the results reported on ClinicalTrials.gov, this trial (NCT05966870) enrolled 22 participants who regularly drank sugar-sweetened beverages (SSBs — drinks like soft drinks or juice with added sugar). The trial asked participants to swap those drinks for unsweetened sparkling water over a 12-week period. The study was measuring several things: how much participants' drink choices changed, and whether there were any changes in blood sugar levels, a longer-term blood sugar marker called HbA1c (a blood test that reflects average blood sugar over roughly three months), and the body's response to insulin (the hormone that helps manage blood sugar). The reported data shows that of the 22 people who started the trial, 11 completed it and 11 did not finish. Despite the trial being listed as completed, the results submitted to ClinicalTrials.gov do not include any actual numerical measurements for any of the primary outcome measures — including changes in drink consumption, blood sugar levels, HbA1c, or insulin-related measures. In other words, the specific numbers that the trial set out to collect were not reported in the structured results data available on ClinicalTrials.gov. Because no outcome numbers were provided in the submitted data, it is not possible to describe what the results showed for any of the measures the trial intended to track. The data was not reported rather than being absent due to no effect — the reason for the missing figures is simply not stated in the submission. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT04520256 · results posted 15 January 2025
According to the results reported on ClinicalTrials.gov, this trial enrolled 384 participants in total, spread evenly across 32 different groups of 12 people each. The trial was testing a weight management programme that combined a core set of activities with various optional add-on components — including social support, strategies for managing dysregulated eating, exercise, feedback, and virtual reality (VR). Each group received a different combination of these add-ons, allowing the researchers to measure whether each individual component made a difference to weight change over 12 months. The reported data shows that, on average across all participants, body weight fell by about 5.8% of each person's starting weight over the 12-month period. When looking at how each individual add-on component compared to the core programme alone, the reported additional changes in weight were small: social support was linked to an extra –0.27%, dysregulated eating strategies to +0.09%, exercise to –0.03%, feedback to +0.44%, and virtual reality to +0.92% — all figures representing a small amount above or below what the core programme alone appeared to produce. Separately, the reported data shows that only about 8 in 100 participants (a proportion of 0.08) reached a weight loss of 5% or more of their starting body weight by month 12. The reported data for each add-on component's contribution to reaching that 5% threshold ranged from about 10 to 15 extra participants in every 100, though these figures represent additional estimated proportions rather than standalone results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02122666 · results posted 26 October 2024
According to the results reported on ClinicalTrials.gov, this trial involved 27 people in total — 12 in a group with a condition called metabolic syndrome (a cluster of health factors such as high blood sugar, excess body fat around the waist, and abnormal cholesterol levels) and 15 in a healthy control group. All 27 participants completed the study with no dropouts. The trial was measuring differences between the two groups in the composition of a specific structure inside muscle cells (called the sarcoplasmic reticulum), as well as measures related to how the body handles insulin and sugar, and body fat levels. Muscle tissue samples were taken from the thigh, and participants also had blood tests and a full-body scan. The reported data shows that for the primary measurement — a ratio of two types of fat molecules (called PC and PE) found in the muscle cell structure — the metabolic syndrome group had a reported value of 2.0, compared with 2.2 in the control group. For one of the secondary measurements, insulin sensitivity (how well the body responds to insulin) was assessed using something called the Matsuda Index, where higher numbers suggest better insulin response. The metabolic syndrome group recorded a value of 2.5 on this index, while the control group recorded 5.6. For total body fat percentage, the reported data shows the metabolic syndrome group averaged 43.7%, compared with 30.6% in the control group. The results for additional insulin-related measures (HOMA-IR) were noted as displayed in a published paper rather than as specific numbers in the registry data, so those figures were not reported here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT03529695 · results posted 23 October 2024
According to the results reported on ClinicalTrials.gov, this trial (NCT03529695) involved two groups of participants: mothers and their young children. A total of 35 mothers and 35 children were enrolled in a standard home visiting programme (called the Standard HVP Curriculum), while 42 mothers and 42 children were enrolled in an obesity prevention version of the programme. The trial was measuring mothers' body weight (using a measure called BMI — a number calculated from height and weight) and infants' weight in pounds, as well as how often participants ate certain foods such as fruit, vegetables, fried food, and soft drink. Of those who started, 20 mothers and 20 children completed the standard programme, and 22 mothers and 22 children completed the obesity prevention programme. The reported data shows that for mothers' BMI, the standard curriculum group recorded figures of 30.6, then 34.0, then 32.0 across three time points, while the obesity prevention group recorded 34.2, then 34.3, then 35.4. For infant weight, the standard curriculum group recorded 20.0, 24.2, and 30.3 pounds across the three time points, compared with 19.3, 22.1, and 28.9 pounds in the obesity prevention group. The reported data also shows counts of participants falling into different categories of food intake frequency at multiple time points — for example, the number of mothers and children reporting how often they consumed fruit, vegetables, fried food, and soft drink shifted across those time points in both groups. However, the data as submitted does not include labels identifying exactly what each time point or frequency category represents, so a full plain-English breakdown of those individual numbers cannot be provided without risking misrepresentation. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT03762135 · results posted 26 August 2024
According to the results reported on ClinicalTrials.gov, this trial involved 78 young people (adolescents) who were split into two groups. Fifty-two participants used a full version of a smartphone app called LIITah, while 26 used a partial version of the app that included only two features (called ELI and SNAP). All 78 participants completed the study — none dropped out. The trial tracked how often the young people visited fast food restaurants, how many calories they purchased at those restaurants, and their Body Mass Index (BMI) percentile (a measure of body weight relative to height, compared to others of the same age). The reported data shows that, for restaurant visits, the full-app group started at an average of 3.1 visits and ended at 1.6 visits across the measurement periods, while the partial-app group went from 2.6 visits down to 1.6 visits. For calories purchased at restaurants, the full-app group's reported figures went from 2,432 calories down to 1,082 calories across the measurement periods, while the partial-app group went from 2,035 calories down to 1,769 calories. These figures represent the numbers recorded at different points during the study, though the specific timing of each measurement point was not detailed in the submitted data. For the secondary outcome, the reported data shows that the average BMI percentile at the time measured was 85.4 for the full-app group and 88.1 for the partial-app group. No further breakdown of BMI data across time points was reported in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT04788511 · results posted 11 June 2024
According to the results reported on ClinicalTrials.gov, this trial (NCT04788511) enrolled 529 people in total — 263 received semaglutide 2.4 mg and 266 received a placebo (an inactive injection). The trial ran for approximately 52 weeks and was measuring two main things: changes in heart failure symptoms and quality of life (using a standardised questionnaire called the Kansas City Cardiomyopathy Questionnaire Clinical Summary Score, or KCCQ-CSS, where higher scores mean better health), and changes in body weight. The reported data shows that, on the KCCQ-CSS questionnaire (scored from 0 to 100), the semaglutide group's scores rose by an average of 16.8 points from where they started, while the placebo group's scores rose by an average of 10.3 points. For body weight, the semaglutide group lost an average of 13.9% of their body weight, compared with 2.5% in the placebo group. The reported data also shows results for several secondary measures: in a six-minute walk test, the semaglutide group walked an average of 23.5 metres further than at the start, compared with 5.8 metres further in the placebo group. A combined scorecard that ranked participants across several heart-related outcomes showed the semaglutide group recorded "wins" in 60.1% of head-to-head comparisons versus 34.9% for the placebo group. A blood marker linked to inflammation (C-reactive protein) was measured as a ratio to starting levels — the semaglutide group's ratio was 0.55 (meaning levels fell) compared with 0.92 in the placebo group (meaning levels stayed closer to where they started). Finally, 65.9% of participants in the semaglutide group lost at least 10% of their body weight, compared with 9.5% in the placebo group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00776035 · results posted 3 May 2024
According to the results reported on ClinicalTrials.gov, this trial (NCT00776035) enrolled 19 people with heart failure — 9 men and 10 women. All 19 participants completed the study with no dropouts. The trial was measuring two things in the heart: how much blood flows through the heart muscle, and how much fatty acid (a type of fuel the heart uses for energy) the heart muscle uses. Both were measured using a specialised imaging scan called a PET scan, which tracks small amounts of injected substances as they move through the body. The reported data shows that, on average, blood flow through the heart muscle was measured at 0.73 units (millilitres per gram per minute) in the men and 0.97 units in the women. For fatty acid use by the heart muscle, the reported average was 85 units (nanomoles per gram per minute) in the men and 139 units in the women. In both measures, the numbers reported for the women were higher than those reported for the men, though the trial does not explain what those differences mean in practical terms. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01868230 · results posted 28 February 2024
According to the results reported on ClinicalTrials.gov, this trial enrolled 148 women in total — 74 in a "Lifestyle Intervention" group and 74 in a "Health and Wellness" comparison group. The trial was looking at weight changes during and after pregnancy, as well as blood sugar-related measurements, in women who had been diagnosed with gestational diabetes (diabetes during pregnancy). Participants were followed at six weeks, six months, and twelve months after giving birth, though the number who provided data at each of those check-in points was smaller than the number who started. The reported data shows that, on average, women in the Lifestyle Intervention group gained 7.9 kg during pregnancy, compared with 10.4 kg in the Health and Wellness group. For weight change after giving birth, the reported figures at the six-week, six-month, and twelve-month check-ins were 3.2 kg, 3.9 kg, and 6.4 kg for the Lifestyle Intervention group, and 3.2 kg, 5.7 kg, and 8.4 kg for the Health and Wellness group (these figures represent average weight change from the time of delivery). Regarding the goal of losing at least 5% of pre-pregnancy weight after birth, the reported data shows that 12 participants in the Lifestyle Intervention group met this goal at each of the three time points, compared with 9, 7, and 6 participants respectively in the Health and Wellness group. The reported data also shows blood sugar-related measurements taken at the same three time points. Average fasting glucose (a measure of blood sugar after not eating) readings were 85.22, 87.41, and 87.41 mg/dL in the Lifestyle Intervention group, and 83.89, 84.92, and 91.52 mg/dL in the Health and Wellness group. Average fasting insulin levels were 14.65, 21.37, and 16.67 units per millilitre in the Lifestyle Intervention group, and 20.57, 26.53, and 21.54 in the Health and Wellness group. HbA1c (a measure reflecting average blood sugar over several months, expressed as a percentage) was reported as 5.08%, 5.19%, and 5.18% for the Lifestyle Intervention group, and 5.04%, 5.20%, and 5.13% for the Health and Wellness group across the three time points. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02751814 · results posted 14 December 2023
According to the results reported on ClinicalTrials.gov, this trial enrolled 175 participants — young children attending early childhood education (ECE) centres. Of those, 112 completed the starting assessments and 130 completed the study overall. The trial was measuring changes in children's physical activity levels, screen time, movement skills, and sedentary behaviour (time spent sitting or inactive) over approximately one year, comparing what was happening at the start of the study to what was happening at the one-year follow-up point. The reported data shows that for the primary measure — the amount of time children spent in moderate-to-vigorous physical activity (that is, activity energetic enough to raise the heart rate) — the reported changes were small, ranging from a decrease of 1.0 minute per day to an increase of 3.3 minutes per day across the different measures taken. For screen time observed in the classroom, the reported data shows decreases of 2.8, 18.1, and 20.9 minutes per day across the measures recorded. Parent-reported screen time appeared to shift between baseline and follow-up, with fewer parents reporting higher amounts of screen time at follow-up than at the start, though the data was not reported in a way that allows a straightforward single-number comparison. For sedentary behaviour and physical activity measured in hours per day, the figures were similar between the starting point and follow-up — for example, time spent in physical activity was reported as 1.7 hours per day at both points. For fundamental movement skills (scored out of 100), scores were also similar across both time points, with overall gross motor scores of 41.7 at baseline and 41.4 at follow-up. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT03382782 · results posted 8 December 2023
According to the results reported on ClinicalTrials.gov, this trial enrolled people across three cohorts and three groups: a Behavioural Weight Loss Intervention (BWLI) group, a group receiving both BWLI and support from a Peer Navigator, and an Integrated Care group (described as treatment as usual). In total, across all three cohorts, 234 people started the trial and the large majority completed it. The trial was measuring changes in body weight and waist circumference as the main (primary) outcome, along with a number of secondary outcomes including quality of life, sense of personal recovery, and self-confidence around eating and exercise. The reported data shows that, for body weight, starting figures across the four reported time points ranged from roughly 222 to 229 pounds for the BWLI group, 222 to 225 pounds for the BWLI & Peer Navigator group, and 215 to 219 pounds for the Integrated Care group. For waist circumference, figures across the reported time points ranged from approximately 45.6 to 46.2 inches (BWLI group), 43.9 to 44.8 inches (BWLI & Peer Navigator group), and 43.8 to 45.0 inches (Integrated Care group). For the secondary measures, quality of life scores (on a scale of 0–126, where higher is better) were reported at around 27–29 across all three groups at both time points. Recovery scores (scale of 24–120) sat in the mid-to-high 90s across all groups. Self-confidence around eating (scale of 0–180) was reported in the range of 99–103 at the first time point, rising to roughly 110–125 at the second. Self-confidence around exercise (scale of 0–90) was reported in the high 60s to mid-70s, with the data not clearly indicating whether the figures shown represent the start or end of the study period for each measure. It is worth noting that the reported data does not always clearly label which figures represent the starting point and which represent the end point for each time period, so direct before-and-after comparisons cannot be made with certainty from the available information. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT04667377 · results posted 2 November 2023
According to the results reported on ClinicalTrials.gov, this trial (NCT04667377) enrolled 387 participants across five groups. Four groups received different doses of an investigational medicine called BI 456906 (planned maintenance doses of 0.6 mg, 2.4 mg, 3.6 mg, or 4.8 mg), while a fifth group received a placebo (an inactive treatment with no medicine). The trial was primarily measuring the percentage change in participants' body weight over approximately 46 weeks (about 11 months). The reported data shows that, by week 46, the placebo group's body weight had changed by an average of −2.82% from where they started. For the BI 456906 groups, the reported average percentage weight changes were −6.19% (0.6 mg group), −12.51% (2.4 mg group), −13.22% (3.6 mg group), and −14.94% (4.8 mg group). In terms of actual kilograms, the reported average changes were approximately −2.68 kg for placebo, and −7.21 kg, −14.75 kg, −15.64 kg, and −18.47 kg for the four BI 456906 dose groups respectively. Changes in waist circumference were also measured, with the placebo group averaging −3.96 cm and the BI 456906 groups ranging from −8.32 cm to −16.01 cm. The reported data also shows the proportions of participants who reached certain weight-loss thresholds by week 46. For losing at least 5% of starting body weight, the figures ranged from 25.9% in the placebo group up to 82.8% in the highest BI 456906 dose group. For losing at least 10%, the range was 11.1% (placebo) to 68.8% (highest dose group). For losing at least 15%, the range was 5.6% (placebo) to 54.7% (highest dose group). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT04881760 · results posted 13 September 2023
According to the results reported on ClinicalTrials.gov, this trial (NCT04881760) enrolled 338 people across seven groups. Participants were given either a placebo (a dummy injection with no active ingredient) or one of several doses of an investigational medicine called LY3437943, delivered in different ways of building up to the final dose. The trial's main goal was to measure the percentage change in body weight over the course of the study. The reported data shows that, for the primary measurement of body weight change, the placebo group lost an average of about 1.6% of their body weight. By comparison, the groups receiving LY3437943 reported average losses ranging from around 7% (at the lowest 1 mg dose) up to approximately 18–17% (at the higher doses of 8 mg and 12 mg). A second, later measurement of body weight change showed similar patterns, with the placebo group averaging about a 2% loss and the higher-dose LY3437943 groups averaging losses of roughly 22–24%. For the secondary measures looking at how many participants lost at least 5% of their body weight, the reported data shows 26–27% of placebo participants reached that threshold, compared with figures ranging from 59% up to 100% across the various LY3437943 dose groups. For a 10% or greater body weight loss, around 3–9% of placebo participants reached that mark, while reported figures for the LY3437943 groups ranged from 25% up to 94% depending on the dose and measurement point. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02813668 · results posted 8 September 2023
According to the results reported on ClinicalTrials.gov, this trial enrolled 2,108 people in a single group called the Lifestyle Intervention Training Program. A total of 1,358 participants completed the study, while 750 did not finish. The trial was measuring whether participants could improve on at least two out of three heart and metabolic health markers — specifically, a meaningful drop in a blood sugar measure called HbA1c (a percentage that reflects average blood sugar over roughly three months), a drop in the top number of a blood pressure reading, and a drop in a blood fat called triglycerides. The study followed participants for up to two years. The reported data shows that, at two separate time points during follow-up, 485 and then 351 participants reached the goal of improving on two or more of those three markers. For blood pressure, the top number (systolic) was reported as 132 mmHg at the start, 127 mmHg at year one, and 128 mmHg at year two; the bottom number (diastolic) was 85, 84, and 84 mmHg at those same time points. The reported HbA1c figures were 6.41% at the start, 6.1% at year one, and 6.3% at year two. Average fasting blood sugar (measured after not eating overnight) was reported as 105.8, 108.6, and 113.6 mg/dl across the three time points. Average body mass index (a measure of weight relative to height) was reported as 27.35, 27.2, and 27.1 kg/m² at baseline, year one, and year two respectively. The reported data also shows that 660 participants at one time point and 481 at another were recorded as new diabetes cases, identified using the HbA1c blood test. It is worth noting that the data as submitted does not clearly label which measurements correspond to which time point for all outcomes, so some figures cannot be matched to a specific year with certainty. Where any detail was not clearly reported in the submitted data, this summary has not assumed or filled in that information. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT03856047 · results posted 18 July 2023
According to the results reported on ClinicalTrials.gov, this trial (NCT03856047) enrolled 706 participants across seven groups. Five groups received different doses of an investigational medication called cagrilintide (0.3 mg, 0.6 mg, 1.2 mg, 2.4 mg, or 4.5 mg), one group received an already-approved weight-management medicine called liraglutide 3.0 mg, and one group received a placebo (an inactive dummy injection). Each group had roughly 99–102 participants at the start, and the trial ran for 26 weeks. The main thing being measured was the percentage change in body weight from the start to the end of the 26 weeks. The reported data shows that, on average, participants in the placebo group lost about 3.0% of their body weight (roughly 3.2 kg) over the 26 weeks. In the cagrilintide groups, the reported average weight losses ranged from about 6.1% (approximately 6.6 kg) at the lowest dose up to about 10.8% (approximately 11.8 kg) at the highest dose. The liraglutide group reported an average loss of about 8.5% (approximately 9.1 kg). The reported data also shows the proportion of participants who lost at least 5% of their starting body weight: this ranged from about 57% in the lowest cagrilintide dose group to about 89% in the highest dose group, compared with about 31% in the placebo group. For a loss of at least 10%, the reported figures ranged from about 15% to about 53% across the cagrilintide groups, versus about 10% in the placebo group. Secondary measures such as waist circumference and total cholesterol levels were also tracked, with waist reductions ranging from about 6.2 cm to 9.5 cm across the cagrilintide groups compared with about 3.4 cm for placebo, and small changes in total cholesterol were reported across all groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT03374956 · results posted 18 July 2023
According to the results reported on ClinicalTrials.gov, this trial involved 193 people in total — 93 in the intervention group and 100 in the control group. All participants completed the study, with no drop-outs recorded in either group. The trial was measuring changes in body weight over the course of the study, comparing the two groups against each other. The reported data shows that, on average, people in the intervention group lost about 7.7% of their body weight, while people in the control group lost about 6.5% of their body weight. The trial also looked at how many people in each group lost at least 5% of their body weight: 81% of the intervention group and 80% of the control group were reported to have reached this point. For a larger amount of weight loss — 10% or more of body weight — the reported figures were 44% of the intervention group and 40% of the control group. It is worth noting that the data submitted to ClinicalTrials.gov does not include information about any side effects or unwanted events, so no conclusions can be drawn from this summary about the safety of either approach. The numbers above simply describe what was measured and recorded for each group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00996866 · results posted 3 July 2023
According to the results reported on ClinicalTrials.gov, this trial (NCT00996866) involved 27 people in total — 13 in a placebo group (receiving a dummy treatment) and 14 in a Vitamin D3 group. All 27 participants completed the study with no drop-outs. The trial was measuring levels of a form of vitamin D in the blood, known as 25(OH)D, which is the standard marker used to assess how much vitamin D a person has in their body. Levels were measured at the start of the trial and again after two months. The reported data shows that at the start of the trial, average blood vitamin D levels were similar between the two groups — 51.1 nmol/L (nanomoles per litre, a unit used to measure substances in the blood) in the placebo group and 49.2 nmol/L in the Vitamin D3 group. After two months, the reported data shows the placebo group's average level remained relatively unchanged at 49.9 nmol/L, while the Vitamin D3 group's average level was reported as 74.5 nmol/L. No other outcome measures were included in the data submitted to ClinicalTrials.gov for this trial. It is worth noting that this was a small study involving only 27 people, and the data as submitted covers only these two measurement points. No additional secondary outcome data was reported in the structured results available on ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT03009110 · results posted 1 June 2023
According to the results reported on ClinicalTrials.gov, this trial (NCT03009110) enrolled 1,624 participants in total — 816 in the group that received a dressing called prophylactic negative pressure wound therapy (NPWT, a type of sealed dressing that applies gentle suction to a wound), and 808 in the group that received a standard wound dressing. The trial was measuring rates of surgical site infections (SSIs — infections that develop at the site of a surgical cut) and other wound complications after surgery. The vast majority of participants in both groups completed the study (806 in the NPWT group and 802 in the standard dressing group). The reported data shows that for the primary outcome — the number of participants who developed a superficial or deep surgical site infection — 29 out of 816 people in the NPWT group and 27 out of 808 people in the standard dressing group had an infection recorded. For the secondary outcomes, the reported data shows that organ-space infections (such as infection inside the abdomen or of the uterine lining) occurred in 2 participants in each group. Other wound complications such as collections of blood or fluid under the skin, or wound separation of 2 cm or more, were recorded in 21 participants in the NPWT group and 25 in the standard dressing group. When all wound complications were combined into a single count, 52 participants in the NPWT group and 54 in the standard dressing group had at least one complication recorded. Participants in both groups reported the same average pain score of 3 out of 10. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02653092 · results posted 1 June 2023
According to the results reported on ClinicalTrials.gov, this trial (NCT02653092) looked at how free fatty acids (FFAs — a type of fat found in the blood) and diet-related changes might affect reproductive hormones, specifically hormones called LH (luteinising hormone) and FSH (follicle-stimulating hormone), which play a role in the menstrual cycle. The trial was split into two groups: one group (Aim 1) explored what happened to hormone levels after participants received FFAs either as a short-term infusion or through a longer-term high-fat diet, while the second group (Aim 2) underwent a procedure called a hyperinsulinemic euglycemic clamp, which is a controlled test used to measure how the body responds to insulin. A total of 84 people started the trial — 26 in the first group and 58 in the second — however only 13 and 18 participants respectively completed the study, meaning a large number did not finish. The reported data shows that for the main (primary) outcome measuring the change in LH pulse amplitude (how strong the hormone signal was), the reported values were 2.33 IU/L for the first group and 2.40 IU/L for the second group. For the other primary outcome — a measure of how much glucose the body processed during the insulin test — the reported figures were 1.98 mg/dL for the first group and 0.0485 mg/dL for the second group. The reported data shows that for secondary outcomes, the response to a hormone signal called GnRH was 567.63 IU/L×min in the first group and 355.12 IU/L×min in the second group. Mean FSH levels were reported as 242.46 IU/L×min and 158.99 IU/L×min respectively. Hormone pulse frequency was reported as 2.33 IU/L in the first group and 1.49 IU/L in the second group. For a smaller sub-group following a high-fat diet, urinary hormone profiles showed a reported change of −10.71 mIU/mg creatinine from the starting point. It is worth noting that the data as submitted does not clearly specify whether these figures represent changes from a baseline or final values, and no comparison or context figures were reported for some measures. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT03686150 · results posted 19 April 2023
According to the results reported on ClinicalTrials.gov, this trial involved children receiving vitamin D3 supplements and was run in two parts. A total of 112 participants started the trial across six groups. Part 1 (four groups, 48 participants in total) was designed to work out the best dose of vitamin D3 to use in Part 2. Part 2 (two groups, 64 participants in total) then tested those doses and measured how many children reached a vitamin D blood level of 40 ng/ml or higher — a target level the researchers had set in advance. Most participants finished the trial, with only nine people across all groups not completing it. The reported data shows that, based on the blood-level analysis from Part 1, two daily dose levels were identified for use in Part 2: 8,000 IU and 50,000 IU. In Part 2, the results differed between the two groups. In Cohort A (the 8,000 IU group), approximately 78.6% of participants — roughly 4 in every 5 — reached the target vitamin D blood level of 40 ng/ml or above. In Cohort B (the 50,000 IU group), the reported figure was 0%, meaning none of the participants in that group were recorded as reaching that target level. No further explanation for this difference was included in the structured data submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01983462 · results posted 14 April 2023
According to the results reported on ClinicalTrials.gov, this trial (NCT01983462) enrolled 33 people across three groups — 11 in each group — who were given either clonidine (a blood pressure medicine), hydrochlorothiazide (another blood pressure medicine), or a placebo (a dummy treatment with no active ingredient). One person in the clonidine group did not complete the trial; everyone else finished. The trial was measuring two main things: aortic stiffness (how rigid the large artery running through the chest and abdomen is, measured using a technique called pulse wave velocity — essentially how fast a pulse travels through that artery) and 24-hour average systolic blood pressure (the top number in a blood pressure reading, tracked over a full day and night). The reported data shows the following pulse wave velocity figures (in metres per second — lower numbers indicate less stiffness): at the start, the clonidine group measured 7.9, the hydrochlorothiazide group 7.0, and the placebo group 8.1. At the end of the study period, those figures were reported as 7.3 for clonidine, 7.0 for hydrochlorothiazide, and 8.0 for placebo. For the 24-hour average systolic blood pressure (in mmHg), the starting figures were 133 for clonidine, 135 for hydrochlorothiazide, and 133 for placebo. The ending figures were reported as 126 for clonidine, 131 for hydrochlorothiazide, and 134 for placebo. No further statistical detail (such as whether any differences between groups were considered meaningful) was included in the submitted results data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT04027608 · results posted 10 January 2023
According to the results reported on ClinicalTrials.gov, this trial enrolled two groups of children: 165 participants in a group called "Satiators" and 36 in a group called "Sensitizers." Of those, 129 Satiators and 29 Sensitizers completed the study. The trial was measuring changes in body weight relative to what is typical for children of the same age and sex — a measure called zBMI (BMI z-score). A zBMI of zero represents the national average for children, a higher number means heavier than average, and a lower number means lighter than average. The reported data shows that both groups had zBMI scores above zero throughout the study, meaning both groups were, on average, heavier than the national average for their age and sex. For the Satiators group, the reported zBMI figures across the measurement points were 0.433, 0.376, and 0.416. For the Sensitizers group, the reported figures were 0.550, 0.610, and 0.593. The data as submitted does not include labels specifying exactly when each measurement was taken, and no additional secondary outcome measures were reported in the structured data provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT04701138 · results posted 15 June 2022
According to the results reported on ClinicalTrials.gov, this trial enrolled 24 participants who all received a dietary supplement. Twenty-three participants completed the study and one did not. The trial was measuring changes in certain molecules in the blood — specifically, substances linked to inflammation and immune activity — before and after taking the supplement. These included three particular fatty acid-related molecules (called 14-HDHA, 17-HDHA, and 18-HEPE), various types of white blood cells, and antibody levels produced by immune cells tested in a laboratory setting. The reported data shows the following blood levels of the three key molecules (measured in nanograms per millilitre, a very small unit of concentration): readings of 15.6, 12.2, 6.6, 8.1, 8.0, and 11.3 ng/mL were recorded across the measurement points. For white blood cell populations, the reported data shows the relative share (out of 1.0, meaning the whole group of cells measured) for different immune cell types — including B cells, monocytes, natural killer cells, T cells, and related subsets — with values ranging from 0.02 to 0.33. For antibody concentrations measured in laboratory cell cultures, the reported figures were approximately 465,802, 457,833, 1,024,891, and 789,526 ng/mL across the measurement time points. It is worth noting that the reported data does not clearly label which individual values correspond to which specific cell type or time point (before or after supplementation), so a direct before-and-after comparison cannot be drawn from the available information alone. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02527200 · results posted 3 February 2022
According to the results reported on ClinicalTrials.gov, this trial looked at liraglutide (an injectable medicine) compared to a placebo (an inactive dummy injection) in children and young people with obesity. The trial had two parts — Part A and Part B — and in total, 56 participants started the study: 37 received liraglutide and 19 received placebo. The main thing being measured was change in BMI (body mass index, a number based on height and weight) expressed as a special age- and sex-adjusted score called an SDS or Z-score, where a more negative number means a lower BMI relative to peers. This was measured at 16 weeks and again at 52 weeks. The reported data shows that across both parts of the trial combined, the liraglutide group's BMI SDS score changed by an average of −0.33 at 16 weeks and −0.50 at 52 weeks, while the placebo group's score changed by −0.29 at 16 weeks and −0.36 at 52 weeks. For the secondary outcomes, the reported data shows that at 16 weeks, about 32% of participants in the combined liraglutide group achieved a reduction of 5% or more in their actual BMI, compared with about 26% in the combined placebo group. At 52 weeks, those figures were approximately 32% for liraglutide and 28% for placebo. When looking at a larger reduction — 10% or more in BMI — the reported numbers were small in both groups across both time points, with around 3% of the combined liraglutide group reaching that threshold at 16 weeks and about 13% at 52 weeks, compared with around 5% and 11% respectively in the combined placebo group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02487251 · results posted 11 January 2022
According to the results reported on ClinicalTrials.gov, this trial involved children and their families across two phases. In Phase 1, a total of 499 participants were enrolled — 434 in a "usual exposure" comparison group and 65 in a "mealtime support activities" group. In Phase 2, 311 participants were enrolled — 152 in a "usual exposure" comparison group and 159 in a group that received meal deliveries and cookware. The trial was measuring changes in children's body weight (using a standard weight-for-age score called a BMI z-score, where 0 represents the middle of the healthy range), as well as changes in how much fruit and vegetables children ate and how often families ate dinner together. It is worth noting that the reported data shows that data collection for body weight was cut short from March 2020 due to the COVID-19 pandemic. The reported data shows that changes in BMI z-scores were very small across all four groups. The Phase 1 comparison group showed a change of +0.006, and the mealtime support group showed a change of +0.0003 — both extremely close to zero. In Phase 2, the comparison group showed a change of +0.04 and the meal delivery group showed a change of −0.02. For fruit and vegetable intake, the reported changes were also very small — generally ranging from around −0.21 to +0.09 cups across the different groups and measures. For family mealtimes, the Phase 1 mealtime support group reported eating dinner together 0.40 more nights per week on average, compared to smaller changes in the other groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT03672227 · results posted 10 January 2022
According to the results reported on ClinicalTrials.gov, this trial looked at a programme called "Mealtime Matters" in Head Start childcare settings in the United States. It involved young children aged 3 to 5, their parents, and their teachers. In total, 164 people started the study across two groups — one group experienced the Mealtime Matters training (112 participants, including 8 teachers, 52 children, and 52 parents), and the other group continued with the usual family-style dining approach (52 participants, including 6 teachers, 23 children, and 23 parents). The trial was measuring things like how much energy (kilojoules/calories) children consumed at lunchtime, and whether teachers' approaches to feeding children at mealtimes changed. The reported data shows that the main thing being measured was the change in the proportion of children eating more than the recommended amount of energy at lunch. In the Mealtime Matters group, the percentage of children eating beyond the recommended amount went down by 10.9 percentage points. In the usual family-style dining group, that figure went down by 56.5 percentage points. The reported data on changes in how teachers handled feeding during mealtimes was listed as a secondary measure, but no numbers were provided for that outcome. Regarding teacher satisfaction, the reported data shows that 7 out of 8 teachers in the Mealtime Matters group reported being satisfied with the training immediately after it finished, and all 8 reported satisfaction at the end of the study period. No satisfaction data was reported for teachers in the comparison group, as they did not receive the training. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02355210 · results posted 23 November 2021
According to the results reported on ClinicalTrials.gov, this trial involved 107 people in total, split across six groups: a placebo group (19 people), two probiotic groups (18 and 16 people), two synbiotic groups — meaning a combination of probiotics and prebiotics — (17 and 19 people), and a prebiotic group (18 people). All participants who started the trial completed it. The trial was measuring two main things: changes in the mix of bacteria living in participants' guts (including whether specific bacterial strains were present), and changes in how "leaky" the gut lining was — assessed by measuring certain sugars in urine after participants drank a sugar solution. The reported data shows the following for gut bacteria composition, expressed as a percentage of bacterial types present. Before the intervention, the figures ranged from 6.0% (Synbiotic 1) to 11.3% (Prebiotic) across the groups. Afterwards, the figures ranged from 9.5% (Probiotic 2) to 17.4% (Prebiotic). For gut leakiness — measured using a ratio of two sugars in urine, where a lower number suggests less leakiness — the reported data shows starting values between 0.32 and 0.37 across all groups. After the intervention, the Placebo group's ratio was reported as 0.36, while the other groups ranged from 0.20 to 0.29. For the secondary outcome, the trial also measured a substance in the blood called lipopolysaccharide (a marker that can indicate bacteria-related activity in the bloodstream), reported in standardised units. The reported data shows that most groups started and ended at 0.02 units. Probiotic 1 was reported at 0.03 at both time points, and Probiotic 2 started at 0.3 and ended at 0.03. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT03649477 · results posted 17 November 2021
According to the results reported on ClinicalTrials.gov, this trial (NCT03649477) enrolled 130 people across three groups: 44 received the higher dose of LV-101 (9.6 mg), 43 received the lower dose (3.2 mg), and 43 received a placebo (a dummy treatment with no active ingredient). The trial was measuring changes in extreme hunger (called hyperphagia), obsessive and compulsive behaviours, anxiety, and overall clinical impression in participants, most likely those with Prader-Willi syndrome. Two participants in the higher-dose group did not complete the study; everyone else finished. The reported data shows the following score changes from the start of the trial to the end. For extreme hunger (scored 0–36, where lower is better), scores dropped by 3.4 points in the higher-dose group, 5.4 points in the lower-dose group, and 2.2 points in the placebo group. For obsessive and compulsive behaviours (scored 0–40), scores dropped by 3.0 points, 3.1 points, and 2.4 points respectively. For anxiety (scored 0–56), the reported reductions were 4.3 points, 8.3 points, and 4.5 points. For overall clinical impression (scored 1–7), the reported scores at the end were 3.6, 3.4, and 3.9 across the three groups. A subset analysis of the hunger questionnaire also showed score reductions of 3.3, 4.6, and 2.2 points for the three groups. The reported data shows changes across all three groups, including the placebo group. What these numbers mean in terms of real-world benefit or harm is not something that can be determined from the figures alone. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
Read the full trial page · View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT03084302 · results posted 16 September 2021
According to the results reported on ClinicalTrials.gov, this trial enrolled 120 pregnant women, with 105 completing the study and 15 not completing it. The trial was set up to track how much time pregnant women spent sitting or being inactive (sedentary behaviour) and how much moderate-to-vigorous physical activity they did across the different stages of pregnancy (trimesters). Researchers used movement-tracking devices to objectively measure these patterns over time. The reported data shows that, out of the full group studied, 45 participants were classified as being in the "high sedentary behaviour" category — meaning they were sitting or inactive for around 10.9 hours per day on average. Separately, 29 participants were classified as being in the "low physical activity" group, which corresponded to roughly 114 minutes of moderate-to-vigorous activity per week (about 16 minutes per day). These categories were identified using a statistical grouping method that sorted participants into patterns based on how their activity levels changed throughout pregnancy. The reported data also shows results for two secondary areas that were tracked. Of the full group, 49 participants were recorded as having gained more weight during pregnancy than is considered within recommended ranges (based on established guidelines). Additionally, 19 participants experienced one or more adverse pregnancy outcomes — a category that included conditions such as high blood pressure disorders during pregnancy, early birth, restricted foetal growth, or gestational diabetes. The data does not break down exactly how many participants experienced each individual condition within that group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT03548935 · results posted 11 August 2021
According to the results reported on ClinicalTrials.gov, this trial (NCT03548935) enrolled 1,961 people in total — 1,306 assigned to receive semaglutide 2.4 mg and 655 assigned to receive a placebo (an inactive injection used for comparison). The trial ran for approximately 68 weeks and was primarily measuring changes in body weight over that period. The reported data shows that, looking at the "in-trial" period (which tracked everyone from the start through to their last contact with the clinic), participants in the semaglutide group had an average body weight change of −15.6%, compared with −2.8% in the placebo group. When looking only at the time participants were actually taking their assigned treatment, those figures were −16.9% and −3.1% respectively. In terms of reaching specific weight-loss thresholds during the in-trial period, 1,047 out of 1,306 people in the semaglutide group and 182 out of 655 in the placebo group were reported to have lost 5% or more of their body weight. For larger reductions: 838 versus 69 participants reached 10% or more; 612 versus 28 reached 15% or more; and 388 versus 10 reached 20% or more. The reported data also shows an average reduction in waist circumference of 14.1 cm in the semaglutide group and 4.4 cm in the placebo group by week 68. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT03426228 · results posted 13 July 2021
According to the results reported on ClinicalTrials.gov, this trial enrolled 349 people in total — 158 who were not pregnant and 191 who were pregnant — all of whom were undergoing IVF (in vitro fertilisation) treatment. The study was measuring how fertility medications used during IVF may relate to changes in blood sugar levels, insulin resistance, cholesterol and thyroid function. Of those who started, 117 non-pregnant participants and 158 pregnant participants completed the study. The reported data shows that, for blood sugar (glucose) levels after treatment, the average fasting glucose reading was 87.62 mg/dL for the non-pregnant group and 82.19 mg/dL for the pregnant group — both below the 110 mg/dL threshold the researchers flagged as abnormal. A separate measurement (reported with a value of 9.37 for non-pregnant and 9.45 for pregnant participants) was also recorded as part of the blood sugar assessment, though the data as submitted does not make entirely clear which specific measure these figures refer to. For cholesterol, the reported average was 199.5 mg/dL in one group and 174.9 mg/dL in the other. For thyroid function (measured using a hormone called TSH, which reflects how the thyroid gland is working), the reported averages were 1.36 and 1.80 μIU/mL across the two groups. No figures were reported for the long-term maternal and fetal outcomes measure. It is important to note that these are averages across groups, and the data as submitted does not include before-and-after comparisons for each individual measure, so the degree of any change over the course of treatment is not reported in a way that can be described here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT03792191 · results posted 24 May 2021
According to the results reported on ClinicalTrials.gov, this trial enrolled 280 people in total — 140 in each of two groups. The trial was comparing two different methods a doctor might use to guide a spinal needle during a lumbar puncture (a procedure where a needle is inserted into the lower back to access fluid around the spine). One group had the needle placement guided by ultrasound (a scan using sound waves), while the other group had the insertion point chosen by the doctor feeling the patient's back by hand (called palpation). All 280 participants completed the trial. The reported data shows that for the primary outcome — the number of times the needle needed to be advanced to get fluid flowing — both groups had a median (middle value) of 3 needle passes. For the secondary outcomes, both groups also had a median of 1 skin puncture (the number of times the needle broke the skin). The number of participants who succeeded on the very first needle pass was 40 out of 140 in the ultrasound group and 45 out of 140 in the palpation group. Those who succeeded on the first skin puncture were 108 out of 140 in the ultrasound group and 111 out of 140 in the palpation group. The reported data shows the procedure took a median of 76 seconds in the ultrasound group and 59 seconds in the palpation group. Patient satisfaction — rated on a scale from 1 (very unsatisfied) to 5 (very satisfied) — had a median score of 5 in the ultrasound group and 4 in the palpation group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT04486235 · results posted 6 May 2021
According to the results reported on ClinicalTrials.gov, this trial (NCT04486235) involved 62 people in total — 32 in the intervention group and 30 in the control group — though 2 people in the intervention group did not finish, meaning 30 from each group were included in the final analysis. The trial was measuring two main things: whether it was practical (feasible) to recruit people from a GP waiting room and deliver a brief intervention there, and how acceptable participants found that intervention. A secondary measure looked at whether weight was discussed during the GP appointment. The reported data shows that, for the acceptability questionnaire (scored out of 42, where a score of 21 or above is considered the benchmark for being acceptable), the intervention group scored an average of 35.8 — above that benchmark. On the feasibility measures, the reported data shows that 60% of patients agreed to be screened (the pre-set benchmark was above 70%); 53.5% of those screened were eligible (benchmark was above 50%); 0% refused to take part because the study focused on weight (benchmark was below 20%); and 86.2% completed the study pamphlet (benchmark was above 80%). For the secondary outcome about whether weight was discussed in the appointment, the reported data shows that in the intervention group, 7 participants said yes and 14 said no, while in the control group, 5 said yes and 11 said no. It was not reported whether the remaining participants answered this question. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02701868 · results posted 14 January 2021
According to the results reported on ClinicalTrials.gov, this trial involved 171 people across two phases. Phase 1 included 21 participants who took part in focus groups to review powdered infant formula preparation instructions printed on packaging and suggest ways to make them easier to read and understand. Phase 2 then enrolled 150 participants, split evenly into two groups of 75: one group followed the original, standard instructions, and the other followed a revised version of the instructions that had been updated based on the Phase 1 focus group feedback. The reported data shows that in Phase 1, between 60% and 100% of focus group participants made specific recommendations for improving the instructions (four separate recommendation figures were reported: 60%, 80%, 100%, and 60%, each relating to a different suggestion). For Phase 2, the trial measured how accurately participants prepared formula bottles compared to what the manufacturer's label intended — specifically, how far off the amount of formula powder was from the expected amount, expressed as a percentage error. The reported data shows that the group using the standard instructions had an average error of −4.66%, meaning they used slightly less formula powder than expected on average. The group using the modified instructions had an average error of −0.67%, meaning their amounts were closer to what the label specified, on average. It is worth noting that no further breakdown of the focus group recommendation figures was provided in the submitted data, and no additional outcome measures beyond these two were reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01200862 · results posted 8 October 2020
According to the results reported on ClinicalTrials.gov, this trial tested an investigational drug called BGS649 and was run in two separate parts. In Part 1, 14 people were enrolled and 13 completed that phase. Part 2 involved a further 15 people — 7 received BGS649 and 8 received a placebo (a dummy treatment with no active ingredient). Part 1 looked at whether the drug was associated with testosterone levels returning to a normal range, while Part 2 looked at measures related to how the body handles insulin and sugar, as well as how the drug moved through the body over time. The reported data shows that Part 2 was stopped early because of inaccuracies in how doses were given to participants, and so only some of the planned measurements were collected. The reported data shows that in Part 1, at the two measurement points (Week 4 and Week 12), 14 and 13 participants respectively had testosterone levels recorded within the defined normal range (2.50–9.50 ng/mL). For Part 2, the insulin resistance scores (called HOMA-IR — where a higher number suggests lower insulin sensitivity) were reported as 7.94 for the BGS649 group and 7.45 for the placebo group; a related measure (QUICKI — where a higher number suggests better insulin sensitivity) was 0.12 for the BGS649 group and 0.13 for the placebo group. Week 12 data for these measures was not collected due to the early termination of Part 2. The reported data also shows how the drug was absorbed and cleared from the bloodstream across three time points, including how long it took to reach its peak level in the blood (just over one hour at each visit) and an estimated time for the body to process half the drug (around 474–489 hours). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02367105 · results posted 31 August 2020
According to the results reported on ClinicalTrials.gov, this trial enrolled 83 men in total — 41 received a placebo alongside a lifestyle therapy programme, and 42 received testosterone alongside the same lifestyle programme. By the end of the study, 36 men in the placebo group and 34 in the testosterone group had completed the trial. The trial was measuring changes in physical function, fitness, body composition, and daily activity levels over the course of the programme. The reported data shows the following changes from the start of the trial to its end. For the primary measure — a standardised physical performance test scored out of 36, where a higher score means better physical function — the placebo plus lifestyle group improved by an average of 4.6 points, and the testosterone plus lifestyle group improved by an average of 4.9 points. For the secondary measures: peak oxygen consumption during exercise (a measure of cardiovascular fitness) rose by 2.8 units in the placebo group and 4.0 units in the testosterone group; scores on a questionnaire about ability to carry out daily activities increased by 2.9 points in the placebo group and 3.1 points in the testosterone group; body weight fell by an average of 10.6 kg in the placebo group and 9.8 kg in the testosterone group; lean body mass (muscle and other non-fat tissue) changed by −2.4 kg and −1.2 kg respectively; and fat mass fell by 8.2 kg in the placebo group and 8.0 kg in the testosterone group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02029976 · results posted 23 July 2020
According to the results reported on ClinicalTrials.gov, this trial involved 264 children in total — 132 in an after-school weight management program and 132 in an "attention control" group (a comparison group that received a different, non-weight-focused activity). The trial was measuring body weight status in children, along with diet quality, physical activity levels, and quality of life. Results were collected at two points: at the end of the program (Year 1) and again one year later (Year 2). Most children completed both stages — around 120–124 out of 132 in each group at each timepoint. The reported data shows that for the main measure — a body weight score called a BMI Z-score (a number that shows how far a child's weight sits from the average for their age and gender, where a higher number means further above average) — both groups started with scores around 1.5 to 1.6, and both groups showed a small increase to around 1.6 to 1.7 by the follow-up period. For diet quality, the weight management program group scored 51.9 out of 100 on a healthy eating scale, compared to 47.6 in the comparison group. For physical activity, both groups spent roughly similar proportions of their time being active — around 4.2–4.5% in moderate-to-vigorous activity and around 67–68% in sedentary (sitting/low-movement) time. For quality of life (scored out of 100, where higher is better), the reported data shows scores ranging from 72.3 to 78.3 across both groups and both timepoints, with figures not reported separately for all individual timepoints in some measures. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02246413 · results posted 11 June 2020
According to the results reported on ClinicalTrials.gov, this trial (known as the RAINBOW trial) enrolled 409 adults in total — 204 in a combined weight and depression management program called the RAINBOW Intervention Program, and 205 receiving their usual care. The trial was measuring two main things at 12 months: body mass index (BMI, a number calculated from a person's height and weight) and depression symptom scores using a questionnaire called the SCL-20. Follow-up continued to 24 months to track these same measures over a longer period. The reported data shows that at the 12-month mark, the RAINBOW group had an average BMI of 35.9 kg/m² compared with 36.6 kg/m² in the usual care group. For depression symptoms, the RAINBOW group recorded an average SCL-20 score of 1.1, while the usual care group recorded 1.4. On this scale, scores above 0.75 up to 1.5 fall in the "mild depression" range, and a score of 1.1 or 1.4 both sit within that band. At 24 months, the reported secondary outcome data shows the two groups had very similar average BMI scores (36.2 kg/m² each) and SCL-20 scores of 1.3 (RAINBOW) and 1.4 (usual care). Average weight at 24 months was reported as 101.8 kg for the RAINBOW group and 102.4 kg for the usual care group; an earlier weight measurement also appeared in the data showing 100.8 kg and 103.4 kg respectively, though the exact time point for that earlier figure was not specified in the data provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01302379 · results posted 5 June 2020
According to the results reported on ClinicalTrials.gov, this trial enrolled 333 participants across four groups. Each group combined either metformin (a medication) or a placebo (a dummy pill) with one of two dietary approaches — a structured lifestyle intervention or standard dietary guidelines. The trial was measuring changes in several blood markers: insulin (a hormone that regulates blood sugar), glucose (blood sugar), C-reactive protein (a marker of inflammation in the body), bioavailable testosterone (the active form of a sex hormone), and sex hormone binding globulin (a protein that carries hormones in the blood). Most participants completed the trial — between 76 and 80 out of each group of roughly 83–84 who started. The reported data shows the following percentage changes from the start of the trial to the end. For insulin levels, the group taking metformin with the lifestyle intervention saw a reported decrease of 21.8%, placebo with lifestyle intervention saw a decrease of 17.7%, metformin with standard dietary guidelines saw a decrease of 13.2%, and placebo with standard dietary guidelines saw a decrease of 1.1%. For blood glucose, the reported changes were smaller across all groups: decreases of 1.2%, 2.3%, and 1.6% in the first three groups respectively, while the placebo with standard dietary guidelines group showed a slight increase of 2.0%. For C-reactive protein, the reported changes ranged from a decrease of 21.4% (metformin with lifestyle intervention) to an increase of 5.9% (placebo with standard dietary guidelines). For bioavailable testosterone, all four groups reported decreases, ranging from 13.7% down to 1.3%. For sex hormone binding globulin, three groups reported increases (ranging from 7.6% to 12.5%), while the placebo with standard dietary guidelines group reported virtually no change at −0.1%. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01590433 · results posted 12 February 2020
According to the results reported on ClinicalTrials.gov, this trial involved 182 people in total — 127 were given a medicine called exenatide and 55 were given a placebo (an inactive substance used for comparison). The trial was measuring changes in body weight after 12 weeks of receiving twice-daily injections of either exenatide or placebo. Of those who started, 75 people in the exenatide group and 33 people in the placebo group completed the full 12 weeks. The reported data shows that the primary outcome being tracked was the percentage change in body weight from the start of the trial to the 12-week mark. According to the results reported on ClinicalTrials.gov, those in the exenatide group showed an average weight change of 6.5%, while those in the placebo group showed an average weight change of 7.5%. No other outcome measures appear to have been included in the submitted results data, so no further figures can be described here. It is worth noting that a meaningful number of participants did not complete the trial — 52 in the exenatide group and 22 in the placebo group — though the reasons for this were not reported in the structured data provided. No information about side effects or safety was included in the submitted results, so nothing can be said about those aspects of the trial. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01456221 · results posted 29 January 2020
According to the results reported on ClinicalTrials.gov, this trial enrolled 366 people in total — 183 in a group that took omega-3 supplements alongside a reduced-calorie diet, and 183 in a placebo group (who received a dummy supplement). The trial was measuring changes in insulin resistance — a term for how well the body responds to insulin, the hormone that controls blood sugar — over a period of three and six months. It also tracked body measurements such as body mass index (BMI, a measure of body size based on height and weight) and waist circumference. Not everyone completed the trial: 119 people in the omega-3 group and 126 in the placebo group finished. The reported data shows that insulin resistance, measured using a scoring system called HOMA-IR (where a score above 3.16 is considered to indicate insulin resistance), was recorded at three points in time for both groups. At the start, the omega-3 group had a score of 7.38 and the placebo group 6.89. At three months, those figures were 6.73 and 6.28 respectively, and at six months, 6.02 and 5.41. Both groups appeared to show lower scores over time. For BMI, the omega-3 group went from 31.53 to 31.1 kg/m², while the placebo group went from 31.16 to 30.25 kg/m². Waist circumference in the omega-3 group went from 100.44 cm to 96.99 cm, and in the placebo group from 99.40 cm to 97.11 cm. Fasting insulin levels (a blood measure related to insulin resistance) also shifted across both groups over the six months, with figures moving from 33.05 to 29.40 µU/mL in the omega-3 group, and from 31.30 to 27.23 µU/mL in the placebo group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02744846 · results posted 20 December 2019
According to the results reported on ClinicalTrials.gov, this trial looked at children from birth to 10 years of age, drawing on a large dataset of records. The study was examining whether children who received antibiotics before the age of two had different body weight outcomes — measured using something called a BMI z-score — compared to children who did not receive antibiotics in that same early period. A BMI z-score is simply a way of comparing a child's weight-for-age and sex against a reference group of children the same age; a score of zero means exactly average, and a positive number means slightly above average. The trial assessed outcomes at two points: around 4–6 years of age (where records for roughly 362,550 children were assessed) and at 10 years of age (where records for approximately 56,730 children were assessed), with large numbers excluded at each stage for not meeting eligibility criteria. The reported data shows that, at the 4–6 year assessment, children without complex ongoing health conditions who had received antibiotics had a BMI z-score difference of around 0.02 to 0.04 units compared to those who had not received antibiotics. For children with complex chronic health conditions, the reported difference was slightly higher, ranging from approximately 0.03 to 0.07 units. At the 10-year assessment, the reported differences were similar in children without complex conditions (around 0.02 to 0.04 units), while for children with complex chronic conditions the reported differences ranged from approximately 0.08 to 0.09 units. All reported differences were positive, meaning the data shows antibiotic-exposed children had slightly higher BMI z-scores on average than those not exposed, though the reported numbers themselves are very small. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01156805 · results posted 13 December 2019
According to the results reported on ClinicalTrials.gov, this trial involved two groups of children: one group (237 participants) received an educational intervention focused on healthy eating and physical activity, while the other group (272 participants) did not receive the intervention and acted as a comparison group. By the end of the study, 181 participants had completed the program in the intervention group and 216 in the comparison group, with 56 people in each group not completing the study. The trial was primarily measuring changes in BMI (body mass index — a number calculated from a person's height and weight, commonly used to assess body size) over time, and also looked at eating habits, physical activity, and height measurements. The reported data shows that the average BMI at the time results were recorded was 16.4 kg/m² in the educational intervention group and 17.0 kg/m² in the non-intervention group. For height, the intervention group averaged 1.21 metres and the comparison group averaged 1.19 metres. The reported data also shows the average heights of parents: fathers in both groups were around 1.74–1.75 metres tall, and mothers were around 1.61–1.62 metres tall. No further detail about changes in eating habits or physical activity over time was included in the submitted results data, so those figures are not available to report here. It is worth noting that these figures represent averages at a single point in time as reported, and no information about how these numbers changed throughout the trial was included in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT03468179 · results posted 13 December 2019
According to the results reported on ClinicalTrials.gov, this trial (NCT03468179) enrolled 10 participants, all of whom completed the study with no drop-outs. The trial involved a single group who consumed an oatmeal meal, and the study was measuring levels of certain naturally occurring substances in the blood — specifically N-acyl-phosphatidylethanolamine (NAPE) and N-acyl-ethanolamides (NAE) — which are types of molecules the body produces. The aim was to track how these blood levels changed over the two hours following the oatmeal meal. The reported data shows that for the primary outcome — the change in blood NAPE levels from the start of the study to 120 minutes after eating the oatmeal — the recorded figure was a decrease of 4.02 nmol/L (nanomoles per litre, a standard unit for measuring tiny amounts of a substance in blood). For the secondary outcomes, blood NAPE levels at 30, 60, and 90 minutes after the meal were reported as 3.36, 2.78, and 4.12 nmol/L respectively. Blood NAE levels were also measured at five time points — at the start and at 30, 60, 90, and 120 minutes after eating — with reported figures of 0.09, 0.08, 0.07, 0.06, and 0.07 nmol/L respectively. No comparison group was included in this trial, so all figures reflect the single oatmeal group only. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02961920 · results posted 7 October 2019
According to the results reported on ClinicalTrials.gov, this trial enrolled 50 adults who were split into two equal groups of 25. One group received a breathing pattern during anaesthesia where the time breathing in compared to breathing out was set at a ratio of 1:2 (meaning twice as long breathing out as in), while the other group had an equal 1:1 ratio. The trial was measuring the level of oxygen in the participants' arterial blood — that is, the blood coming directly from the heart — at set time points during a surgical procedure performed with the patient lying face-down. The reported data shows oxygen levels (measured in units called mmHg, which simply reflects how much oxygen is present in the blood) at two separate time points. For the 1:2 breathing ratio group, the reported values were 178.71 mmHg and 185.25 mmHg at the two time points. For the 1:1 breathing ratio group, the reported values were 198.04 mmHg and 202.54 mmHg at the same time points. One participant in each group did not complete the trial, so the final completed numbers were 24 in each group. No other outcome measures were included in the submitted results data — any additional measurements that may have been taken were not reported on ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT03245762 · results posted 25 June 2019
According to the results reported on ClinicalTrials.gov, this trial looked at whether intranasal oxytocin (a hormone delivered as a nasal spray) had any effect on the ability of infants and children with Prader-Willi syndrome (PWS) to suck and swallow safely. PWS is a genetic condition that can affect feeding from birth. A total of 15 participants took part — 10 received the oxytocin nasal spray and 5 received a placebo (an inactive nasal spray that looked the same). All 15 participants completed the trial with no one dropping out. The reported data shows that the primary outcome measured was overall improvement in swallowing ability, assessed through a swallow study. The results were broken down into three categories for each group, though the labels for each category were not included in the submitted data. For the oxytocin group (10 participants), the reported numbers across the three categories were 8, 1, and 1. For the placebo group (5 participants), the reported numbers were 4, 1, and 0. Because the category labels were not provided in the data, it is not possible to describe exactly what each number represents beyond what was submitted. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02365285 · results posted 19 March 2019
According to the results reported on ClinicalTrials.gov, this trial (NCT02365285) enrolled 23 people in total, split into four groups based on race (African-American or White) and the order in which they received the study drug or a dummy pill (placebo). Each participant received both galantamine (a 16 mg dose) and a placebo at different times during the study — this is called a "crossover" design. The trial was measuring whether galantamine changed levels of a substance in the blood called F-2 isoprostanes, which is used as a marker of "oxidative stress" (a type of chemical pressure on the body's cells). This was checked at two time points: 2 hours and 4 hours after taking the treatment. Of the 23 who started, 19 completed the study. The reported data shows very small changes in F-2 isoprostane levels across all groups. At the 2-hour mark, the galantamine group for African-American participants showed a change of −0.003 pg/ml (picograms per millilitre, a very small unit of measurement), the White participants on galantamine showed −0.006 pg/ml, the African-American placebo group showed +0.01 pg/ml, and the White placebo group showed −0.006 pg/ml. At the 4-hour mark, the reported figures were 0 pg/ml for African-American participants on galantamine, −0.008 pg/ml for White participants on galantamine, +0.003 pg/ml for African-American participants on placebo, and −0.008 pg/ml for White participants on placebo. No further statistical analysis results (such as whether these differences were considered meaningful) were included in the data submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02244424 · results posted 8 March 2019
According to the results reported on ClinicalTrials.gov, this trial (NCT02244424) involved 164 participants in total — 102 in the "Tools for Teen Moms" intervention group and 62 in the standard care group (called MIHP Standard Care). The participants included both teenage mothers and their infants (51 mother-infant pairs in the intervention group and 31 in the standard care group). The trial was measuring changes in infant growth over time, specifically tracking infants' weight and length at three separate points and converting those measurements into a standard comparison score (called a z-score), which shows how an infant's weight compares to other babies of the same age and sex. A z-score of zero means exactly average; negative numbers mean below average, and positive numbers mean above average. The reported data shows that infants in both groups had weight-for-age z-scores that were slightly below the average reference population across all three measurement points. For the Tools for Teen Moms group, the reported z-scores at the three time points were −0.46, −0.33, and −0.22. For the standard care group, the reported z-scores were −0.44, −0.46, and −0.21. The reported data shows that both groups started at similar scores and ended at similar scores by the final measurement point, with the intervention group showing a gradual upward trend across the three time points and the standard care group showing a slight dip at the second time point before recovering. No other outcome measures were included in the submitted results data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02742766 · results posted 15 January 2019
According to the results reported on ClinicalTrials.gov, this trial (NCT02742766) tested an investigational medicine called GSK3008356 across three parts. In Part 1, 80 people took part — 20 received a dummy treatment (placebo) and 60 received the study medicine at various doses and timing schedules, over up to 8 days. In Part 2, a further 24 people took part over up to 22 days, again split between placebo and different doses of the medicine. Part 3 involved obese participants, but the reported data shows that zero participants started that part of the trial. The trial was primarily measuring a range of physical checks — including body examinations, heart tracings (ECGs), heart monitoring, blood and urine tests, and vital signs such as blood pressure and pulse — to record any values or findings that fell outside normal ranges. The reported data shows the following counts of participants with notable findings in Part 1. For physical examinations, abnormal findings were recorded in 2 of 20 placebo participants and between 0 and 1 participant in each of the medicine dose groups. For vital signs of potential concern, the numbers were very low across all groups — 0 in most groups, with 1 participant noted in two of the medicine dose groups and 0 in the placebo group. For heart tracings (ECGs), the numbers ranged from 0 to 4 participants across all groups, including 4 in the placebo group and varying numbers in the medicine groups. For continuous heart monitoring, only 1 participant (in one medicine dose group) had a clinically significant finding recorded, with 0 in all other groups including placebo. For laboratory blood and urine test values, the data was not fully reported in the excerpt provided, so complete numbers for that measure cannot be stated here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT03364335 · results posted 27 November 2018
According to the results reported on ClinicalTrials.gov, this trial enrolled 258 people across five groups. Participants were randomly assigned to receive either a placebo (an inactive treatment) or one of four different dose combinations of two investigational compounds — referred to here as "Leu Sil" and "Leu Met Sil" — at either a 1.0 mg or 4.0 mg dose. The trial ran for 168 days (roughly six months) and was primarily measuring changes in body weight. Not everyone finished the trial: of the 258 who started, 202 completed it, with between 37 and 42 people finishing in each group. The reported data shows that, for the main outcome (percentage change in body weight from the start to day 168), the placebo group's average weight went up by about 1.1%, while the Leu Sil 1.0 mg group's average weight also rose slightly, by about 0.7%. The Leu Sil 4.0 mg, Leu Met Sil 1.0 mg, and Leu Met Sil 4.0 mg groups showed small average decreases of around 0.5%, 0.9%, and 0.6% respectively. For the secondary outcomes, the reported data shows similar small shifts in actual body weight (in kilograms), waist measurements, and blood cholesterol levels across all groups. When looking at how many people lost 5% or more of their body weight, the numbers were small across all groups: 2 people in the placebo group, 1 in the Leu Sil 1.0 mg group, 6 in the Leu Sil 4.0 mg group, 7 in the Leu Met Sil 1.0 mg group, and 3 in the Leu Met Sil 4.0 mg group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02134522 · results posted 8 June 2018
According to the results reported on ClinicalTrials.gov, this trial (NCT02134522) involved only one participant in a single group receiving CPAP (Continuous Positive Airway Pressure — a device that helps keep the airway open during sleep). The trial was measuring two things over a 12-week period: the amount of fat in the liver (measured using an MRI scan) and blood sugar levels two hours after drinking a sugary drink (known as an oral glucose tolerance test). The reported data shows that for the one participant who completed the trial, the percentage of fat in the liver changed by minus 4.8 percentage points from the start of the study to the 12-week mark. For the two-hour blood sugar measurement, the reported data shows a change of plus 5 mg/dl (milligrams per decilitre, a unit used to measure the concentration of sugar in the blood) over the same period. It is important to note that because only one person took part, these figures represent the experience of that single individual only. It is also worth noting that with just one participant, this trial was extremely small, and the reported data shows results for that one person alone. No comparison group or broader conclusions can be drawn from a study of this size. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02692560 · results posted 11 May 2018
According to the results reported on ClinicalTrials.gov, this trial (NCT02692560) involved 60 people split into two groups: 29 people in the "I-STAND" group and 31 people in the "Healthy Living" group. The trial ran for 12 weeks and was primarily measuring whether the I-STAND programme was associated with a change in the number of hours people spent sitting each day. A range of other things were also tracked, including how often people moved from sitting to standing, how many long unbroken sitting periods they had, physical function, blood pressure, and fasting blood sugar levels. By the end of the study, 29 out of 29 I-STAND participants and 25 out of 31 Healthy Living participants completed the trial. The reported data shows that, on average, people in the I-STAND group sat for about 70 minutes less per day compared to where they started, while people in the Healthy Living group sat for about 6.5 minutes more per day than where they started. For the secondary measures, the Healthy Living group averaged about 2.2 more sit-to-stand transitions per day, while the I-STAND group showed almost no change (minus 0.1 transitions). The I-STAND group averaged 2.5 fewer long unbroken sitting bouts per day, compared to virtually no change (0.1) in the Healthy Living group. On a physical function scale of 0–12 (where higher means better function), the I-STAND group's average score went down by 0.5 points and the Healthy Living group's went up by 0.2 points. Systolic blood pressure (the top number in a blood pressure reading) fell by an average of 3.4 units in the I-STAND group and 1.5 units in the Healthy Living group. Fasting blood sugar levels rose by an average of 8.8 mg/dL in the I-STAND group and 2.4 mg/dL in the Healthy Living group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01435603 · results posted 27 April 2018
According to the results reported on ClinicalTrials.gov, this trial involved 331 adults who were randomly placed into one of two groups: 167 received standard lifestyle advice, and 164 received that same advice plus an additional structured lifestyle intervention. The trial was primarily measuring changes in body weight over 12 months. By the end of the study, 128 people in the standard advice group and 129 in the intervention group had completed the trial. The reported data shows that both groups lost a small amount of weight on average over the 12 months, measured as a percentage change from their starting weight. The standard lifestyle advice group had an average weight change of −0.15%, meaning a very slight reduction. The advice plus lifestyle intervention group had an average weight change of −1.42%, also a reduction. Negative numbers here mean the groups weighed slightly less on average at 12 months than they did at the start. The trial also planned to measure costs, quality of life scores, blood cholesterol, and blood sugar levels (HbA1c) as secondary outcomes, but the reported data shows no numerical results were submitted to ClinicalTrials.gov for any of these secondary measures. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00807768 · results posted 27 April 2018
According to the results reported on ClinicalTrials.gov, this trial enrolled 601 people who had been treated for endometrial (uterine) cancer. Participants were split into two groups: 301 received pelvic radiation therapy, and 300 received a combination of brachytherapy (internal radiation), paclitaxel, and carboplatin (two chemotherapy medicines). The trial's main goal was to track how many people in each group experienced a return of their cancer or died during the study period — a measure called "recurrence-free survival." The reported data shows that in the primary outcome, 44 participants in the radiation therapy group and 43 participants in the chemotherapy-plus-brachytherapy group had a recurrence or death event. For deaths alone, 39 were recorded in the radiation group and 37 in the chemotherapy-plus-brachytherapy group. When looking at where cancer returned, vaginal recurrences were reported in 6 participants in each group; pelvic or lymph node recurrences were reported in 12 participants in the radiation group and 25 in the chemotherapy-plus-brachytherapy group; and distant recurrences were reported in 47 participants in each group. The reported data also includes patient-reported scores for fatigue, nerve-related symptoms (neurotoxicity), and overall quality of life, measured at several points during the study. Fatigue scores (on a scale of 0–52, where higher means less fatigue) were broadly similar between groups across time points, ranging roughly from 35 to 42. Nerve symptom scores (0–16, higher meaning fewer symptoms) were similar at the start but appeared somewhat lower in the chemotherapy-plus-brachytherapy group at later time points. Quality-of-life scores (0–120, higher meaning better quality of life) were also broadly comparable between groups across all time points, generally sitting in the mid-to-high 90s to low 100s. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02235870 · results posted 8 March 2018
According to the results reported on ClinicalTrials.gov, this trial (NCT02235870) enrolled 198 people in the Obalon treatment group and 189 people in the sham (dummy/placebo) control group, making a total of 387 participants. The trial was measuring changes in total body weight loss over 24 weeks, comparing people who swallowed the Obalon balloon capsule against people who went through the same process but without an active balloon. The study tracked what percentage of total body weight participants lost, and how many people in each group lost at least 5% of their total body weight. The reported data shows that, on average, participants in the Obalon treatment group lost approximately 6.86% of their total body weight, while those in the sham control group lost approximately 3.59% of their total body weight. Regarding the second primary measure, the reported data shows that 120 out of the participants in the Obalon treatment group achieved a loss of at least 5% of their total body weight. For comparison, a pre-specified additional analysis reported that 58 participants in the sham control group reached that same 5% total body weight loss mark. The trial set out to test whether the difference between the two groups exceeded a pre-defined threshold of 2.1 percentage points in total body weight loss. It is worth noting that not everyone completed the full study — 38 people in the treatment group and 61 people in the sham group did not finish. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02192905 · results posted 22 February 2018
According to the results reported on ClinicalTrials.gov, this trial enrolled 43 adults into a single group that combined a behavioural weight loss program with a habit-formation mobile app. The study was primarily looking at whether the program was practical and workable — in other words, its *feasibility* — by tracking things like how many people were recruited and stayed in the program, how often participants used a problem-solving feature in the app, and how many new habits they tried to build. Out of 559 people who made contact about the study, 43 began the program, and 42 of those 43 completed it. The reported data shows that, on average, participants used the app's problem-solving function about 23.7 times over the course of the study, and attempted an average of 17.4 new habits. The trial also measured two secondary outcomes — things the researchers were interested in but were not the main focus. One was a problem-solving score (rated on a scale of 28 to 140, where higher numbers indicate stronger problem-solving ability); the reported average change in that score from the start to 8 weeks was −0.64, meaning it was very slightly lower at the end. The other secondary outcome was body weight: the reported average change was −1.9%, meaning participants' weight was, on average, slightly lower at the end of the program. It is important to note that this trial had no comparison group, so the reported numbers reflect what happened in this one group only. The reported data shows what was measured and recorded, not whether any changes were caused by the program itself. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00953173 · results posted 9 February 2018
According to the results reported on ClinicalTrials.gov, this trial involved 671 people who all received a LAP-BAND (an adjustable band placed around the stomach as a weight-loss procedure). The trial was measuring the percentage change in participants' total body weight over time. Of the 671 people who started, 389 completed the trial, while 282 did not finish. The reported data shows that the one outcome measure recorded was the percentage change in total body weight, which was reported as minus 18.0% on average across the group. In plain terms, this means that on average, participants' body weight was reported to have decreased by 18% from their starting weight. No other outcome measures — such as secondary outcomes related to health conditions or quality of life — were included in the submitted results data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01632280 · results posted 8 February 2018
According to the results reported on ClinicalTrials.gov, this trial looked at a brain stimulation technique called tDCS (transcranial direct current stimulation) in relation to weight change over 12 months. Twelve people took part in total — six received active tDCS (real stimulation) and six received sham tDCS (a dummy version that mimicked the procedure without delivering real stimulation). One person in the active tDCS group did not complete the study, while all six in the sham group finished. The reported data shows that for the primary outcome — body weight measured in pounds — both groups recorded different average weights at various points across the study. The active tDCS group started at an average of around 285 lbs and their final recorded average was around 278 lbs. The sham tDCS group started at an average of around 245 lbs and their final recorded average was around 207 lbs. For the secondary outcomes, eating disinhibition (a measure of how much people tended to overeat in certain situations, scored from 0 to 16) was reported as starting at 7.0 in the active group and 3.8 in the sham group, and finishing at 5.0 and 3.6 respectively. A computer-based reaction time test measuring the ability to hold back a response — where a shorter time suggests better self-control — showed reductions in both groups across two conditions (food-related and neutral images), with the reported numbers ranging from around -47 to -73 milliseconds change from the start of the study. It is worth noting that this was a very small trial with only 12 participants, so the reported numbers reflect a limited snapshot. The data was not reported in a way that allows direct comparison of weight change within each group over time beyond the figures listed above. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01869348 · results posted 4 October 2017
According to the results reported on ClinicalTrials.gov, this trial involved 40 adults who were split into two groups of 20 — one group was placed on a waiting list (the control group) and the other received a monitor-based intervention. The trial ran for 12 weeks and was primarily measuring any change in the amount of physical activity participants did, counted in minutes over a seven-day period. One person from each group did not complete the trial, leaving 19 completers in each group. The reported data shows that, over the 12-week period, the wait list control group's physical activity actually decreased by an average of 2.25 minutes per week, while the monitor intervention group's physical activity increased by an average of 50.93 minutes per week. These are the only numbers reported for the primary outcome. The trial also intended to measure several other things — including time spent sitting, motivation to be active, physical fitness (using a six-minute walk test), body composition, and physical function — however, no numerical results for any of these secondary outcomes were reported in the data submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00521079 · results posted 20 February 2017
According to the results reported on ClinicalTrials.gov, this trial involved 294 participants in total — 192 in the vBloc group and 102 in the placebo group. The trial was testing a device called the Maestro System, which delivers a therapy known as vBloc. The main things being measured were how much excess body weight participants lost over 12 months, and how often serious device- or procedure-related unwanted events occurred. A small number of participants in each group were classed as "surgical roll-ins" (early practice cases), and most participants completed the study — 178 in the vBloc group and 97 in the placebo group. The reported data shows that, after 12 months, the vBloc group lost an average of 17% of their excess body weight, while the placebo group lost an average of 16% of their excess body weight. The trial had set out to find at least a 10 percentage point difference between the two groups in favour of vBloc, but the reported numbers show the two groups were very close together. Regarding serious unwanted events related to the device or procedure, 6 events were recorded in the vBloc group and 3 in the placebo group; the data does not break this down further into rates or context. The reported data also shows a secondary measure — the proportion of participants who lost at least 25% of their excess body weight. In the vBloc group, 22% of participants reached that level, compared with 25% in the placebo group. No other secondary outcome figures were reported in the submitted data, so any additional results are not available here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01826604 · results posted 3 October 2016
According to the results reported on ClinicalTrials.gov, this trial enrolled 301 people in total — 144 in the group that used a surgical tool called the Alexis O C-section retractor (a device used to hold the surgical opening during a caesarean section) and 157 in the control group, which did not use the retractor. Most participants completed the trial: 136 in the retractor group and 148 in the control group. The trial was measuring whether using this retractor made a difference to wound problems and a range of other outcomes after a caesarean section. The reported data shows that for the main outcome — the number of people who experienced a wound infection or wound disruption (where the wound doesn't heal properly) — 38 out of 136 participants in the retractor group and 37 out of 148 in the control group were recorded with this outcome. For the secondary outcomes, which looked at things like blood loss, length of surgery, time spent in hospital after the operation, nausea medication use, and the need to return to hospital, the reported data shows participant counts of 20 versus 19, 14 versus 13, 6 versus 6, and 18 versus 18 across the retractor and control groups respectively. It is worth noting that the reported data does not clearly label which specific number corresponds to which individual secondary outcome, so a full breakdown cannot be provided here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01327976 · results posted 27 May 2016
According to the results reported on ClinicalTrials.gov, this trial involved 239 people in total — 162 received the active vBloc device (a surgically implanted device that sends electrical signals to the nerve connecting the brain and stomach) and 77 received a non-active (sham) version of the same device, meaning neither group knew whether their device was switched on. The trial was measuring three main things over 12 months: the rate of serious medical events linked to the device or procedure, the amount of excess body weight lost, and how many participants lost at least a certain amount of excess weight. The reported data shows that 3.7% of people in the active device group experienced a serious medical event related to the implant, procedure, or device, compared to 0% in the sham group. For weight loss, the active device group lost an average of 24.4% of their excess body weight (the weight above what is considered a healthy level for their height), while the sham group lost an average of 15.9% — a difference of about 8.5 percentage points, which was less than the 10-percentage-point difference the trial had aimed to show. For the responder targets, the reported data shows 52.5% of active device participants lost at least 20% of their excess weight (the trial had aimed for at least 55%), and 38.3% lost at least 25% (the trial had aimed for at least 45%). The sham group figures were 32.5% and 23.4% respectively for those same thresholds. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01746264 · results posted 2 May 2016
According to the results reported on ClinicalTrials.gov, this trial (NCT01746264) involved 19 participants, all of whom completed the study — none dropped out. The trial had a single group, which received Vitamin D3 supplements. The study was measuring a range of things before and after the supplementation, including blood vessel function, vitamin D levels in the blood, cholesterol, triglycerides (a type of fat found in the blood), body mass index (BMI, a measure comparing weight to height), and physical activity levels. The reported data shows the following before-and-after figures for the group. For the primary measure — blood vessel function, tested using a technique called Flow Mediated Dilatation (FMD), which looks at how much a blood vessel widens in response to increased blood flow — the reported figures were 9.5% before and 10.4% after. For vitamin D levels in the blood, the reported figures were 55.9 nmol/L before and 86.9 nmol/L after. Total cholesterol was reported as 3.69 mmol/L before and 4.03 mmol/L after. Triglyceride levels were reported as 1.19 mmol/L before and 1.58 mmol/L after. BMI was reported as 36.1 kg/m² before and 36.4 kg/m² after. Physical activity, measured using a standard questionnaire and expressed in MET-minutes per week (a unit reflecting the energy used during activity), was reported as 1,786.6 before and 2,799.1 after. It is worth noting that because this trial had only one group and no comparison (control) group, the reported data shows measurements taken at two time points within the same group of people, but does not include a separate untreated group for comparison. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00543140 · results posted 9 March 2016
According to the results reported on ClinicalTrials.gov, this trial followed 303 people who had a REALIZE™ Adjustable Gastric Band surgically implanted. Of those, 231 completed the study while 72 did not finish. The trial was primarily measuring how often people needed a follow-up operation — specifically a band revision, replacement, or removal — due to a serious device-related medical event occurring more than three years after the original implant. The reported data shows that approximately 8.91% of participants had one of these device-related re-operations between years three and five after implantation. On the secondary measures, participants' excess body weight was reported to have changed by an average of −35.6% at five years, meaning on average they had lost roughly a third of their excess weight compared to when they started. A blood sugar marker called HbA1c (a measure of average blood sugar levels over time) was reported to have changed by −0.22 percentage points from the starting level. The trial also tracked participants' self-reported quality of life using a standardised survey (the SF-36), where scores range from 0 to 100 with higher scores meaning better quality of life. The reported data shows the physical component score changed by +8.1 points and the mental component score changed by +1.1 points over five years. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01505387 · results posted 3 April 2015
According to the results reported on ClinicalTrials.gov, this trial involved 50 people in total — 25 in a placebo group (receiving a dummy treatment) and 25 in a group taking a supplement called Litramine. Of those who started, 24 in each group went on to receive the treatment, and by the end of the 24-week study, 23 people in the placebo group and 24 in the Litramine group had completed it. The trial was primarily measuring changes in body weight over 24 weeks, and also planned to look at waist and hip measurements, Body Mass Index (a measure calculated from height and weight), blood test results, and blood pressure. The reported data shows that, on average, people in the placebo group gained 1.62 kg over the 24 weeks, while people in the Litramine group had an average change of −0.62 kg (meaning a small reduction on average). These are the only numbers available from the structured results. For the secondary outcomes — waist and hip circumference, Body Mass Index, blood counts, and blood pressure — no figures were reported in the data submitted to ClinicalTrials.gov, so those results cannot be described here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00678834 · results posted 16 September 2014
According to the results reported on ClinicalTrials.gov, this trial enrolled 80 people across three groups. Forty participants were people scheduled for surgery who took a supplement called tocotrienol (200 mg); fifteen were also surgery patients who took a related supplement called tocopherol (200 mg); and twenty-five were healthy volunteers who took a higher dose of tocotrienol (400 mg daily). The trial was measuring how much of these vitamin E-related compounds ended up in various body tissues — such as fat tissue, brain, heart, and liver — as well as in the blood and skin of the healthy volunteers. Not everyone who started the trial finished it: 24 of the 40 in the first group completed the study, all 15 in the second group completed it, and 16 of the 25 healthy volunteers completed it. The reported data shows the levels of tocotrienol (measured in nanomoles per gram of tissue — a very small unit used to measure tiny amounts of a substance) found in different tissues. In the surgery patients who took tocotrienol, the reported levels were 9.94 in fat tissue, 1.29 in brain tissue, 5.37 in heart tissue, and 0.42 in liver tissue. In the surgery patients who took tocopherol, the reported levels were noticeably higher across the same tissues: 28.6 in fat, 50.5 in brain, 31.9 in heart, and 64.3 in liver. For the healthy volunteers taking tocotrienol, blood levels started at 0.01 at week zero, rose to 1.9 by week six, and the data for blood at week twelve was not reported. Skin levels were reported as 2.5 at week zero and 1.5 at week twelve. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01421589 · results posted 1 July 2014
According to the results reported on ClinicalTrials.gov, this trial enrolled 15 participants, all of whom completed the study. All participants were in a single group that received growth hormone treatment. The trial was measuring whether growth hormone had any relationship with how well the muscles' energy-producing processes functioned in obese people who had lower-than-normal levels of growth hormone. The main thing being measured was how quickly a muscle energy molecule called phosphocreatine recovered after light exercise — a way of assessing how efficiently the muscles produce energy. The reported data shows that for the primary measure, a statistical relationship (called a correlation coefficient, which is a number between -1 and 1 showing how closely two things move together) of 0.74 was found between changes in a muscle growth signal (IGF-1 gene activity in muscle) and changes in that muscle energy recovery measure after 12 weeks of treatment. For the secondary measures, the reported data shows the following changes from the start of the trial to 12 weeks: a circulating blood protein linked to growth hormone (IGF-1) increased by 218 µg/L; IGF-1 gene activity in muscle was 2.1 times higher; waist circumference decreased by 3 cm; a marker associated with inflammation in the blood (hsCRP) decreased by 1.78 mg/L; and fasting blood sugar increased by 6 mg/dL. No comparison group (such as a placebo group) was included in the reported data, so these figures reflect changes within the one treatment group only. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00806260 · results posted 13 September 2013
According to the results reported on ClinicalTrials.gov, this trial enrolled 80 participants across six groups, with numbers ranging from 8 to 18 people per group. The study was designed to measure how alcohol and a study drug called VI-0521 affected a person's speed, coordination, and accuracy on a computerised test called the CogScreen Pathfinder Number (PFN) test — a roughly 20–25 minute computer task that checks things like reaction time, how precisely someone moves a cursor to targets, and short-term memory. The trial ran across up to three separate testing periods, and by the final period, between 5 and 12 participants remained in each of the four crossover groups. The reported data shows that on the PFN test, scores are considered normal between 1.17 and 2.16, with higher scores suggesting more difficulty with the tasks. In Period 1, the group that received real alcohol recorded a score of 1.90, compared to 1.57 for the group that received an alcohol-free placebo drink. For the second and third testing periods — where participants received either VI-0521 or a matching placebo tablet — the reported scores were very close together: in Period 2, the placebo group scored 1.69 and the VI-0521 group scored 1.64; in Period 3, those figures were 1.65 and 1.64 respectively. All of these values fall within the stated normal range of the test. The reported data also includes coordination and accuracy sub-scores for the same test, with figures hovering around 1.60–1.68 across most groups and periods, again all within the normal range as defined by the trial. It is worth noting that some outcome details — such as the full breakdown of coordination errors — were not separately listed in the submitted results data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01250509 · results posted 18 February 2013
According to the results reported on ClinicalTrials.gov, this trial (NCT01250509) involved 47 people in total — 24 in the CALMM group and 23 in a waitlist control group (who waited rather than receiving the intervention straight away). By the end of the study, 19 people in the CALMM group and 21 in the waitlist group had completed it. The trial measured several things, with the main focus being changes in abdominal (belly) fat, as measured by a type of body scan called a DEXA scan. Secondary measurements included body weight, a biological marker called telomerase activity (a substance found in blood cells), and self-reported feelings of stress using a standard questionnaire. The reported data shows that, on average, belly fat increased by 68.2 grams in the CALMM group and by 50.0 grams in the waitlist control group over the course of the study — so both groups showed a reported rise in abdominal fat. For body weight, the CALMM group showed an average change of −0.03 kg (essentially no change), while the waitlist group showed an average increase of 0.38 kg. For telomerase activity, the reported average change was 0.24 units in the CALMM group and 0.15 units in the waitlist group. For perceived stress scores, the CALMM group reported an average decrease of 0.20 points on the questionnaire scale, while the waitlist group reported an average increase of 0.03 points — noting that higher scores on this scale indicate greater perceived stress. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00675506 · results posted 7 January 2013
According to the results reported on ClinicalTrials.gov, this trial (NCT00675506) enrolled 60 people in total — 31 assigned to a drug called TH9507 and 29 assigned to a placebo (a dummy treatment with no active ingredient). By the end of the study, 19 people in the TH9507 group and 17 in the placebo group completed the full 12 months. The trial was measuring several things related to body fat, heart health markers, blood fats, blood sugar, growth hormone levels, and muscle energy function in people over the course of one year. The reported data shows the following changes from the start of the study to 12 months. For the main thing being measured — the amount of deep belly fat (called visceral adipose tissue, measured using a CT scan) — the TH9507 group showed an average change of −16 cm², while the placebo group showed an average change of +19 cm². For the thickness of the wall of a neck artery (a marker sometimes used to look at cardiovascular changes), the TH9507 group showed a change of −0.03 mm compared to +0.01 mm in the placebo group. For blood fat levels, total cholesterol changed by +4 mg/dL (TH9507) versus +7 mg/dL (placebo); HDL cholesterol ("good" cholesterol) by +4 versus +3; LDL cholesterol ("bad" cholesterol) by +4 versus +1; and triglycerides (another type of blood fat) by −26 versus +12. For blood sugar measures, fasting glucose changed by +2 mg/dL (TH9507) versus +1 mg/dL (placebo), and a two-hour sugar test result changed by −11 versus −3. Growth hormone pulse levels changed by +0.54 nanograms/mL (TH9507) versus +0.20 (placebo). Finally, a measure of muscle energy function changed by +0.01 (TH9507) versus −1.02 (placebo). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00960843 · results posted 3 April 2012
According to the results reported on ClinicalTrials.gov, this trial enrolled 51 people in total — 25 in the "Conventional Adjustment" group and 26 in the "Intraband Pressure" group. The trial was looking at two different approaches to adjusting a gastric band (a device placed around the stomach as part of a weight-loss procedure), and it followed participants for 180 days (about six months). The main thing being measured was how much of their excess body weight participants lost over that period. By the end of the study, 23 people in the conventional group and 21 in the intraband pressure group had completed the trial. The reported data shows that, for the primary measure — the percentage of excess weight lost over six months — the conventional adjustment group lost an average of 13.2% of their excess weight, while the intraband pressure group lost an average of 24.2% of their excess weight. For one of the secondary measures, the average pressure recorded inside the band at day 180 was 0.7 mmHg (a unit of pressure) in the conventional group and 15.8 mmHg in the intraband pressure group. The other secondary measure looked at the rate of weight loss per week: the conventional group averaged 0.18 kg per week, while the intraband pressure group averaged 0.43 kg per week. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01447433 · results posted 6 March 2012
According to the results reported on ClinicalTrials.gov, this trial (NCT01447433) enrolled 53 people in total — 26 in a group that received calcium plus vitamin D supplements, and 27 in a control group (who did not receive the supplements). Both groups also appeared to be following some form of dietary or lifestyle programme, as weight changes were recorded for everyone. By the end of the study, 22 people in the calcium-plus-vitamin-D group and 21 in the control group had completed the trial, with a small number dropping out from each group. The trial was measuring changes in body weight, body composition (fat mass, lean muscle mass, and fat around the organs), body measurements, and blood pressure. The reported data shows that, on average, people in the calcium-plus-vitamin-D group lost 3.9 kg in body weight, compared with 3.5 kg in the control group. For body fat mass, the reported average reductions were 2.8 kg and 1.9 kg respectively; for lean muscle mass, the figures were −0.9 kg and −1.4 kg; and for fat stored around the internal organs (visceral fat mass), the reductions were 0.47 kg and 0.29 kg. Body fat as a percentage of total weight reportedly fell by 2.6 percentage points in the supplement group and 1.5 percentage points in the control group. The estimated area of visceral fat (fat around the organs, measured in square centimetres) fell by 12.5 cm² in the supplement group and 6.8 cm² in the control group. For body measurements, waist circumference fell by 6.2 cm versus 5.1 cm, abdominal circumference by 4.6 cm versus 5.8 cm, and hip circumference by 4.2 cm versus 3.2 cm. For blood pressure, the top (systolic) number fell by 8.3 mmHg in the supplement group and 12.1 mmHg in the control group, while the bottom (diastolic) number fell by 6.0 mmHg and 5.0 mmHg respectively. It is worth noting that the reported data does not include information on whether these differences between the two groups were statistically meaningful (that is, whether they were large enough to be unlikely due to chance), so those figures cannot be interpreted further here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01136291 · results posted 23 February 2011
According to the results reported on ClinicalTrials.gov, this trial involved 82 pregnant women who were divided into two groups: 40 women took part in a physical exercise programme and 42 women did not exercise as part of the study. Nearly all participants finished the trial — 39 in the exercise group and 41 in the no-exercise group. The trial was measuring how much weight the women gained during pregnancy, and also asked them to rate their quality of life using a standard questionnaire. The reported data shows that, when looking at total weight gained across the whole pregnancy (from before pregnancy to the end), women in the exercise group gained an average of 10.3 kg, while women in the no-exercise group gained an average of 11.5 kg. When looking only at weight gained during the study period itself (from when they joined the study to their final check-up), the exercise group gained an average of 7.7 kg compared to 8.1 kg in the no-exercise group. For quality of life, participants filled in a questionnaire scored from 0 (worst) to 100 (best) — the exercise group reported an average score of 49.8, while the no-exercise group reported an average score of 42.2. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00715754 · results posted 11 January 2010
According to the results reported on ClinicalTrials.gov, this trial enrolled 47 infants, and all 47 completed the study with none dropping out. The trial was measuring body composition and size in newborns — specifically, how much of a newborn's body weight is made up of fat (called "adiposity"), as well as the size of the baby's abdomen and estimated weight before birth, both measured by ultrasound at 35 weeks of pregnancy. The reported data shows three main measurements. First, body fat in newborns, measured within 24 to 72 hours after birth using a specialised technique called air displacement plethysmography (a method where a baby sits in a small sealed chamber to measure body volume and calculate fat levels), came in at an average of 11% of total body weight. Second, the baby's abdominal circumference as measured by ultrasound at 35 weeks of pregnancy was reported as an average of 32.6 centimetres. Third, the estimated foetal weight at 35 weeks of pregnancy sat at the 60.8th percentile on average — meaning, on average, the estimated weight was higher than roughly 61 out of 100 babies at that stage of pregnancy according to standard reference charts. It is worth noting that this trial had a single group of participants with no comparison group reported in the submitted data, so the numbers above reflect measurements across all infants rather than a comparison between two different treatments or approaches. No secondary outcome data was reported in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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Not medical advice. These are results as reported by the trial sponsor to a public registry, summarised in plain English. They describe what a trial recorded, not whether a treatment is suitable for any person. Verify anything important against the original registry record and discuss what it means for you with your doctor.