Printed from Voxsanity (voxsanity.com.au) — NCT06704022 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
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Phase 1 Type 2 Diabetes Trial, Not Yet Recruiting
NCT06704022
voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice
Who may and may not be able to join
AI generated eligibility 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
Who may be able to join
- People aged 40 to 65 years old, of any gender.
- People who have type 2 diabetes confirmed in their medical records, and who are able to keep their medications the same (same type, number, and dose) throughout the study.
- People whose HbA1c blood sugar level is between 6.5% and 9.5%, based on a blood test taken at the screening visit or within the past month, or as referred by a doctor (confirm with trial site if unsure what this means for you).
- People with a body mass index (BMI) between 20 and 29.9 (considered normal weight to overweight).
- People whose body weight has stayed within 3 kg of their current weight for the two months before the study begins.
- People who are taking no more than three diabetes tablets by mouth, and one of those must be Metformin; other allowed diabetes tablets include Sulfonylurea, SGLT2 inhibitors, and DPP4 inhibitors.
- People who are male, or females who are not pregnant, not breastfeeding, and are at least 6 weeks past giving birth before the study starts.
- People who are willing to follow the study instructions, including consuming the study product as directed and completing any required forms or questionnaires.
- People who are willing to avoid taking any diabetes-specific nutritional formulas (other than the study product) for the entire study.
- People who are willing to keep their diet and physical activity levels the same throughout the study.
- People who are able to swallow a capsule that is 25mm long and 9mm wide.
- People who have waited at least four weeks after finishing a previous research study that involved eating or taking a study food or drug, and who have read and signed the informed consent form agreeing to follow study procedures.
Who may not be able to join
Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.
- People who have type 1 diabetes or have ever had a serious condition called diabetic ketoacidosis.
- People who use insulin injections or a type of injectable diabetes medication called GLP-1 agonists to control blood sugar.
- People who are currently using diabetes-specific nutritional drinks or supplements (such as Glucerna® or Boost) more than once a week in the past four weeks — though people who can stop using these for at least four weeks before the study starts may not be excluded (confirm with trial site).
- People who follow an unusual eating pattern such as a very low carbohydrate, ketogenic, or high protein diet (for example, the Atkins diet).
- People who have an eating disorder, severe memory or thinking problems, a significant neurological or psychiatric condition, alcohol dependency, substance misuse, or other conditions that, in the investigators' opinion, might affect their ability to follow the study.
- People who have galactosemia (a condition affecting how the body processes a type of sugar) or lactose intolerance.
- People who have a long-term illness that, in the investigator's opinion, could affect their safety or the study results, including but not limited to:
- A serious heart event in the six months before the study, or a history of heart failure, based on a doctor's evaluation.
- End-stage organ failure (such as end-stage kidney disease) or having had an organ transplant.
- Current or past kidney disease, being on dialysis, or having severe gastroparesis (a condition where the stomach empties very slowly).
- A diagnosed liver disease such as liver cirrhosis or late-stage liver scarring. (Note: people with stable chest pain called angina will not be excluded.)
- People with an ongoing, contagious infectious disease such as active tuberculosis, Hepatitis C, or HIV.
- People who currently have an active cancer diagnosis or who have been treated for cancer in the last six months, except for certain non-melanoma skin cancers.
- People who have taken herbal products, dietary supplements, or certain medications in the four weeks before the study starts that could strongly affect blood sugar, body weight, muscle, metabolism, appetite, or gut bacteria — for example, orlistat, naltrexone/bupropion (Contrave), phentermine/topiramate (Qsymia), lorcaserin (Belviq), cannabis, steroid medications, or probiotic/prebiotic supplements. People who stopped taking these at least four weeks before the study starts may not be excluded (confirm with trial site).
- People who have taken medications in the week before the screening visit — other than their regular treatments — that could significantly affect how the gut moves, such as opioids or anticholinergics; laxatives are allowed if use stays unchanged; certain stomach acid medications (proton pump inhibitors) are allowed if a 48-hour break is taken before swallowing the study capsules and they are not restarted until 4 hours after (confirm with trial site).
- People using medications that speed up gut movement (prokinetics), unless they are willing and able to stop taking them for the study, with a two-week break beforehand.
- People who have used antibiotics (other than on the skin) within 12 weeks before screening — though people may be considered once a 12-week break is completed (confirm with trial site).
- People who currently have an infection requiring medication or antibiotics, who have recently had inpatient surgery, or who have received steroid treatment (other than inhaled, nasal, eye-drop, or skin-applied steroids) in the last three months.
- People with a previous gut condition, surgery, or radiation treatment that, in the investigator's opinion, could interfere with consuming or digesting the study product, or could cause a blockage that prevents the capsule from passing through — this includes conditions such as achalasia, eosinophilic esophagitis, or previous surgery on the oesophagus, stomach, small intestine, or colon. Appendix or gallbladder removal more than three months before screening is acceptable.
- People diagnosed with Crohn's disease, ulcerative colitis, or coeliac disease.
- People with a known structural gut abnormality such as strictures or fistulas that could cause a blockage.
- People with a movement disorder of the gut, such as gastroparesis, intestinal pseudo-obstruction, systemic sclerosis, or Ogilvie's syndrome.
- People with a history of difficulty swallowing (oropharyngeal dysphagia) or any other swallowing disorder that could create a risk of inhaling the capsule.
- People who have fewer than three bowel movements per week.
- People who have taken probiotic or prebiotic capsule supplements within one month before screening — though people may be considered once a one-month break is completed (confirm with trial site).
- People who have previously had a fecal microbiota transplant (a procedure involving transfer of gut bacteria).
- People who have had a colon cleanse or bowel preparation procedure within the past two weeks.
- People with clotting or bleeding disorders — though people taking a blood-thinning medication such as Plavix® with no reported problems during blood draws may be allowed, at the physician's discretion.
- People who have blood or blood-related conditions such as haemophilia, thalassemia, sickle cell disease, hereditary spherocytosis, or G6PD deficiency.
- People who have received a blood transfusion within the last three weeks.
- People who are allergic or intolerant to any ingredient in the study products.
- People who regularly do intense exercise (such as high-intensity aerobic activity or heavy physical labour) for one hour or more, three or more times per week — though people who are able to reduce their exercise levels may be considered (confirm with trial site).
- People who are currently enrolled in a weight loss program.
- People who are scheduled to have an MRI scan at any point during the study — though people may be considered once their MRI has been completed (confirm with trial site).
- People who are pregnant or breastfeeding.
- People who are planning to become pregnant during the study.
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Contact this trial
Phone: 8664934633
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Status
Not Yet Recruiting
Phase
Phase 1
Sponsor
Nimble Science Ltd.
Registry
ClinicalTrials.gov
Start date
1 September 2025
Est. completion
1 August 2026
This date has passed while the registry still lists the trial as open to participants. Sponsors often update a trial's status without revising its projected end date, so it may well still be recruiting — but the record is out of date in at least one respect. Check with the study contact before relying on either.
Where this trial is recruiting
🇨🇦 Canada
Primary endpoints
Primary Outcome
Can't join this trial?
Data last synced from ClinicalTrials.gov: 29 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.
Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.