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Enrolling by invitation Not applicable

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

NCT07736547 · tracked via the Priya Life Science Turkey tracker
Phase
Not applicable
Started
2026-07-01
Last updated
2026-09-29

Condition(s) studied

Overweight (Without Type 2 Diabetes) With Weight-related ComorbiditiesOverweight (BMI > 25)

Investigational drug(s) / intervention(s)

AI-Guided Microbiome-Targeted Nutritional SupplementMatching Placebo (B)Lifestyle counselling

AI-Guided Microbiome-Targeted Nutritional Supplement: A fixed, two-phase oral nutritional supplementation regimen developed using an AI-guided analysis of prior gut microbiome and metabolic-health data. All participants assigned to the active arm will follow the same prespecified regimen. During Weeks 0-12, participants will take two sachets and two capsules daily. During the maintenance supplementation period, Weeks 13-24, participants will take two capsules daily. The AI-guided process was used only during formulation development and will not personalize or modify the supplementation regimen for individual participants during the study.

Matching Placebo (B): A placebo formulated to match the active supplement in appearance, taste, smell, packaging, dosage form, administration schedule, and storage conditions. Participants will receive the placebo orally for two consecutive 12-week periods, for a total of 24 weeks. The placebo will not contain active prebiotic, probiotic, synbiotic, postbiotic, or other bioactive components expected to influence body weight or gut microbiome outcomes. The placebo will be administered as during Weeks 0-12, participants will take two sachets and two capsules daily. During Weeks 13-24, participants will take two capsules daily.

Lifestyle counselling: Participants in both study arms will receive identical standardized lifestyle counselling delivered by trained personnel using a predefined counselling manual. Each contact will last approximately 15-20 minutes and will provide general evidence-based guidance on balanced nutrition, portion awareness, and physical activity. The counselling will not constitute an individualized intensive calorie-restriction or behavioral weight-loss program.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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 peptide-1 co-agonist, a sodium-glucose cotransporter-2 inhibitor, a dipeptidyl peptidase-4 inhibitor, a sulfonylurea, insulin, or another antidiabetic agent. * Use of a glucagon-like peptide-1 receptor agonist or glucose-dependent insulinotropic polypeptide/glucagon-like peptide-1 co-agonist for any indication within 12 months before randomization. * Use of another anti-obesity medication, including orlistat, naltrexone/bupropion, or phentermine/topiramate, within 6 months before randomization. * Planned initiation during the 24-week study of a weight-loss medication, structured commercial weight-loss program, very-low-calorie diet, or bariatric procedure. * History of bariatric surgery. * History of gastrointestinal surgery other than appendectomy or uncomplicated cholecystectomy. * Active inflammatory bowel disease, celiac disease, microscopic colitis, chronic pancreatitis, malabsorption syndrome, or another chronic severe gastrointestinal disease likely to affect nutrient absorption or study adherence. * Acute gastroenteritis within 4 weeks before randomization. * Colonoscopy bowel preparation within 12 weeks before randomization. * Fecal microbiota transplantation within 12 months before randomization. * Active malignancy or malignancy treated within 6 months before screening, except adequately treated non-melanoma skin cancer. * Stage 3b to 5 chronic kidney disease, defined as an estimated glomerular filtration rate below 45 mL/min/1.73 m2. * Decompensated liver disease or Child-Pugh class B or C liver disease. * Alanine aminotransferase or aspartate aminotransferase greater than 3 times the upper limit of normal at screening, unless judged clinically insignificant and approved by the investigator. * Untreated overt thyroid disease, or initiation or dose modification of thyroid medication within 3 months before randomization. Stable treated hypothyroidism is permitted. * Use of systemic corticosteroids within 4 weeks before randomization. * Use of immunosuppressive medication or biologic or immunomodulatory therapy within 5 half-lives before randomization. * Pregnancy or lactation. * For participants of childbearing potential, unwillingness to use effective contraception during the 24-week blinded intervention period. * Severe psychiatric illness or cognitive impairment that, in the investigator's judgment, would impair informed consent, participant safety, or adherence to study procedures. * Active eating disorder, defined as at least 2 affirmative responses on the SCOFF screening questionnaire or a clinical diagnosis of anorexia nervosa, bulimia nervosa, or binge-eating disorder. * Heavy alcohol use or active substance use disorder. * Current use of a very-low-calorie diet, ketogenic diet, medically supervised weight-loss diet, or another highly restrictive diet that excludes major food groups. * Current cigarette smoking with a stated intention to attempt smoking cessation during the 24-week study, or initiation of nicotine-replacement or other smoking-cessation pharmacotherapy within 3 months before randomization. * Participation in another interventional clinical study within 30 days before screening. * Known hypersensitivity or clinically significant intolerance to any component of the active supplement or placebo. * Any condition that, in the investigator's judgment, would compromise participant safety, adherence, or study integrity.

Primary outcome measure(s)

  • Percent Change in Body Weight From Baseline to Week 12 — Baseline to Week 12
    Percent change in body weight will be calculated as 100 x \[(Week 12 body weight - baseline body weight) / baseline body weight\]. Negative values indicate weight loss. Body weight will be measured in kilograms to the nearest 0.1 kg using a calibrated digital scale after an overnight fast of at least 8 hours, in light clothing, without shoes, after voiding, and at approximately the same time of day. Two measurements will be obtained. If they differ by no more than 0.3 kg, their mean will be used. If they differ by more than 0.3 kg, a third measurement will be obtained and the median of the three measurements will be used.

Trial sites (1)

FacilityCityRegionStatus
Başakşehir Çam and Sakura City Hospital Istanbul Turkey (Türkiye)
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07736547 on ClinicalTrials.gov ↗ ← All trials in Turkey