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Life sciences · Interventional Study
ClinicalTrials.gov · September 29, 2026
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Interventional Study.
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Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
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Registry record from ClinicalTrials.gov (NCT07736547). This is a study registration, not published results. Lead sponsor: Varol TUNALI. Recruitment status: ENROLLING_BY_INVITATION. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 80 participants (ESTIMATED). Conditions: Overweight (Without Type 2 Diabetes) With Weight-related Comorbidities, Overweight (BMI > 25). Interventions: DIETARY_SUPPLEMENT: AI-Guided Microbiome-Targeted Nutritional Supplement; DIETARY_SUPPLEMENT: Matching Placebo (B); BEHAVIORAL: Lifestyle counselling. Primary outcome measures: Percent Change in Body Weight From Baseline to Week 12 , Baseline to Week 12. Brief 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.