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.
Inclusion Criteria:
Exclusion Criteria:
The active intervention and placebo will be matched in appearance, taste, smell, packaging, administration schedule, and storage conditions. Laboratory personnel performing biomarker and microbiome analyses and the statistician performing the prespecified primary analysis will also remain masked to treatment allocation until database lock. Emergency unmasking will be permitted only when knowledge of allocation is essential for participant management, and every unmasking event will be documented.
Participants will receive the fixed AI-guided microbiome-targeted nutritional supplement orally for 24 weeks. The first 12 weeks will constitute the primary weight-loss supplementation phase, followed by a maintenance supplementation phase from Week 13 through Week 24. The formulation will be identical for all participants in this arm and will not be personalized or modified using AI during the study. Participants will also receive standardized lifestyle counselling identical to that provided in the placebo arm.
Participants will receive matching placebo orally for two consecutive 12-week periods, for a total of 24 weeks. The placebo will be matched to the active supplement in appearance, taste, smell, packaging, administration schedule, and storage conditions and will not contain components expected to influence body weight or gut microbiome outcomes. Participants will also receive standardized lifestyle counselling identical to that provided in the active-supplement arm.
Istanbul, Turkey (Türkiye)
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