Obesity Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• Men and pre-menopausal women between 18 and 45 years old
• People with a body mass index (BMI) between 30.0 and 40.0 (a measure of body weight relative to height that the trial site can calculate)
• Women who are not using hormonal birth control must agree to use an approved method to prevent pregnancy for the entire study, such as a double barrier method (e.g., condom with spermicide), an implant or intrauterine device (IUD), tubal ligation, abstinence, or a relationship with a vasectomized or same-sex partner
• People who can read, speak, and understand English
• People who are largely inactive — meaning they do structured exercise (such as running or weightlifting) no more than one day per week, for no longer than 60 minutes at a time, over the past year
• People who are willing to be assigned to either study group at random
• People who are willing to follow all study procedures
• People who have voluntarily signed a consent form approved by an ethics committee, and agreed to the relevant privacy authorisations, before the study begins

Who may not be able to join:

• People whose body weight has changed by more than 5% in the last 3 months
• People who have made significant changes to their diet or physical activity level in the last 3 months
• People who weigh more than 396 lb (180 kg)
• People who have been diagnosed with Type 1 or Type 2 diabetes
• People whose fasting blood sugar level is 126 mg/dL or higher
• People whose HbA1c (a measure of long-term blood sugar levels) is 6.5% or higher
• People with blood pressure higher than 140/90 mmHg
• People with a history or current diagnosis of certain heart conditions, including heart failure, coronary artery disease, significant heart valve problems, heart defects present from birth, serious irregular heartbeat, stroke, peripheral artery disease with symptoms, stable chest pain (angina), heart attack, or heart surgery within the last 6 months; significant abnormalities on a heart tracing (ECG); a pacemaker or implanted heart device; or an inability to complete a fitness (VO2max) test
• People with anaemia (low red blood cell levels, as measured by specific blood test thresholds)
• People with kidney disease, as indicated by specific blood or filtration rate results
• People with significantly abnormal liver enzyme levels in blood tests
• People with serious digestive conditions such as severe acid reflux (GERD), irritable bowel syndrome (IBS), Crohn's disease, or chronic constipation or diarrhoea
• People with a chronic, active, or latent infection requiring ongoing antibiotic or antiviral treatment, or who have HIV, or active hepatitis B or C being treated with antivirals
• People with a current or past history of eating disorders
• People with abnormal bleeding, a bleeding disorder, or clotting problems (self-reported)
• People diagnosed with Chronic Obstructive Pulmonary Disease (COPD), a long-term lung condition
• People with certain abnormal blood fat levels — specifically, triglycerides above 500 mg/dL or LDL ("bad") cholesterol above 190 mg/dL
• People who have donated whole blood in the last 3 months, or platelets or plasma in the last week, or who plan to donate during the study
• People who have received active treatment (including monoclonal antibody therapy) for an autoimmune condition in the last 6 months
• People who drink more than 7 alcoholic drinks per week (women) or 14 drinks per week (men), or who binge drink more than once a month
• People who have smoked or used tobacco, e-cigarettes, nicotine, THC, or cannabis products in the last 3 months; or who have a longer smoking history and stopped smoking fewer than 5–10 years ago (confirm specific threshold with trial site)
• People who have worked night shifts in the last 6 months or plan to do so during the study
• People with a known allergy to lidocaine or other local anaesthetics
• People with an overactive thyroid (hyperthyroidism), including those whose thyroid levels are currently normal due to medication; people with an underactive thyroid (hypothyroidism) may be retested after evaluation, but any medication change must have been stable for at least 3 months (confirm with trial site)
• People who have had bariatric (weight-loss) surgery or any other surgery for obesity
• People who have had cancer (other than certain skin cancers) in the last 5 years and are not in remission, or who have received anti-hormonal cancer therapy in the last 6 months
• People with a diagnosed psychiatric or psychotic condition that would prevent them from following the study protocol, or who have been hospitalised for a psychiatric condition within the past year
• People who are currently pregnant, have given birth in the last 12 months, are currently breastfeeding, or plan to become pregnant during the study period
• People with Polycystic Ovarian Syndrome (PCOS, self-reported)
• People with bone disease (self-reported), including a history of a fracture from a standing height or lower without trauma, or who are taking prescription medication for low bone density or osteoporosis (calcium, vitamin D, or oestrogen are allowed)
• People who were hospitalised for COVID-19 in the last 12 months; people who tested positive but were not hospitalised must have been free of symptoms for at least 14 days
• People who have had a partial or full hysterectomy (self-reported)
• People who are not willing to have biological samples (such as blood or tissue) stored for possible future research use
• People who are not willing to undergo a procedure called microdialysis (a technique used to sample fluids from body tissue; confirm details with trial site)
• People with metal implants, devices, or other metal-containing objects in their body that are incompatible with MRI scanning, or who have large metal-containing tattoos
• People who are unable to participate in MRI scans due to claustrophobia or because their body size exceeds the equipment's physical limits, based on the investigator's assessment
• People who have a positive result on a drug screening test at the start of the study
• People taking certain medications, including:
  • Anyone whose dose of a regular medication changed in the last 3 months
  • Certain heart medications such as beta blockers, centrally acting blood pressure drugs, blood thinners, anti-arrhythmic drugs, or antiplatelet drugs (other than low-dose aspirin)
  • Certain psychiatric medications such as most sedatives or sleeping tablets, mood stabilisers, anti-epileptic drugs, stimulants, ADHD medications, or antipsychotic drugs
  • Chronic oral steroids (inhaled steroids are allowed), or oral steroid courses taken more than once in the past 12 months
  • Certain bladder or sexual function medications (5-alpha reductase inhibitors, daily phosphodiesterase type 5 inhibitors)
  • Hormonal substances such as anabolic steroids, anti-oestrogens, anti-androgens, oestrogen or progesterone (for reasons other than contraception), growth hormone, insulin-like growth factor, any medication for diabetes or blood sugar lowering, metformin for any reason, any medication specifically intended to cause weight loss, or any substance specifically intended to increase muscle size
  • Regular use of narcotic pain medications, regular non-steroidal anti-inflammatory drugs (NSAIDs) or acetaminophen (paracetamol), or muscle relaxants used two or more days per week
  • Ongoing systemic antibiotics, antivirals, antifungals, antiparasitic medications, high-potency topical steroids covering a large body surface area, monoclonal antibodies, anti-rejection drugs, or immune-suppressing medications
• People with any other condition that, in the investigator's judgement, would affect their safety or the reliability of the study results

Important: Always verify eligibility with the trial site directly before applying.