By InvitationNot Applicable

AIM-WEIGHT: AI-Guided Microbiome-Targeted Nutritional Intervention for Weight Loss

Turkey (Türkiye)80 participantsStarted 2026-08-01

Plain-language summary

AIM-WEIGHT is a clinical study evaluating whether a fixed microbiome-targeted nutritional supplement can support weight loss in adults with overweight or obesity who do not have prediabetes or diabetes. The formulation was developed using an artificial-intelligence-guided analysis of gut microbiome and metabolic-health data. The AI system will not select or modify treatment for individual participants during the study. Eighty participants will be randomly assigned to receive either the active nutritional supplement or a matching placebo for 24 weeks. Both groups will receive the same standardized lifestyle counselling. The main question is whether participants receiving the active supplement will have a greater percentage reduction in body weight after 12 weeks than those receiving placebo. The investigators hypothesize that the active intervention will produce greater weight loss. Assessments through Week 24 will also examine whether the effect is maintained during continued treatment, together with changes in waist circumference, general health measures, safety, treatment adherence, and gut microbiome features.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age 18 to 65 years, inclusive. * Body mass index of 25.0 to 40.0 kg/m2 at screening. * No previous diagnosis of prediabetes or diabetes. * Glycated hemoglobin (HbA1c) below 5.7% at screening. * Fasting plasma glucose below 100 mg/dL at screening. * Stable body weight, defined as a self-reported absolute change of no more than 5% or 3 kg, whichever is smaller, during the 3 months before screening. * Willing and able to provide written informed consent. * Willing and able to comply with study visits, assigned supplement or placebo use, and the assessment schedule. * Willing to provide fasting venous blood and stool samples according to the study schedule. * Willing to receive standardized lifestyle counseling during the 24-week blinded intervention period. * No systemic antibiotic use within 8 weeks before randomization. * No probiotic, prebiotic, synbiotic, or postbiotic supplement use within 12 weeks before randomization. * If hypertension or dyslipidemia is present, antihypertensive or lipid-lowering treatment must have been initiated and the dose must have remained unchanged for at least 3 months before randomization, with no treatment change planned at the time of randomization. Exclusion Criteria: * Prediabetes or diabetes identified by medical history, HbA1c, or fasting plasma glucose. * Use of glucose-lowering medication, including metformin, a glucagon-like peptide-1 receptor agonist, a glucose-dependent insulinotropic polypeptide/glucagon-like…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Percent Change in Body Weight From Baseline to Week 12

Timeframe: Baseline to Week 12

Trial details

NCT IDNCT07736547

SponsorVarol TUNALI

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-03-30

View on ClinicalTrials.gov More Overweight (Without Type 2 Diabetes) With Weight-related Comorbidities trials