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

NCT07736547 | Enrolling By Invitation

• 1 other identifier: Enbiosis_AIM-WEIGHT
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Obesity; Overwieght; Weight loss; Supplement; Artificial intelligence; Microbiome

Outcome Measures

Primary Outcomes (1)

• Percent Change in Body Weight From 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.

  Baseline to Week 12

Secondary Outcomes (7)

• Percent Change in Body Weight From Baseline to Week 24

  Baseline to Week 24

• Proportion of Participants Achieving at Least 5% Body-Weight Loss at Week 12

  Baseline to Week 12

• Change in Waist Circumference From Baseline to Week 12

  Baseline to Week 12

• Proportion of Participants Achieving at Least 5% Body-Weight Loss at Week 24

  Baseline to Week 24

• Change in Waist Circumference From Baseline to Week 24

  Baseline to Week 24

Other Outcomes (8)

• Percent Change in Body Weight From Week 12 to Week 24 During Maintenance Supplementation

  Week 12 to Week 24

• Proportion of Participants Achieving at Least 5% Body-Weight Loss at Both Week 12 and Week 24

  Baseline through Week 24

• Absolute Change in Body Weight From Baseline at Weeks 12 and 24

  Baseline to Weeks 12 and 24

Study Arms (2)

AI-Guided Microbiome-Targeted Nutritional Intervention

EXPERIMENTAL

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.

Dietary Supplement: AI-Guided Microbiome-Targeted Nutritional Supplement; Behavioral: Lifestyle counselling

Matching Placebo

PLACEBO COMPARATOR

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.

Dietary Supplement: Matching Placebo (B); Behavioral: Lifestyle counselling

Interventions

Matching Placebo (B) DIETARY_SUPPLEMENT

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.

Matching Placebo

AI-Guided Microbiome-Targeted Nutritional Supplement DIETARY_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.

AI-Guided Microbiome-Targeted Nutritional Intervention

Lifestyle counselling BEHAVIORAL

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.

AI-Guided Microbiome-Targeted Nutritional Intervention; Matching Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Varol TUNALI: lead

Study Sites (1)

Başakşehir Çam and Sakura City Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Overweight; Obesity; Weight Loss

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Study Officials

• Varol TUNALI, Dr.

  Enbiosis Biotechnology Limited

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Medical Officer (CMO)

Model Details: Two-arm, parallel-group study. Participants will be randomized in a 1:1 ratio to receive either the fixed AI-guided microbiome-targeted nutritional intervention or matching placebo for 24 weeks. Both groups will receive identical standardized lifestyle counselling. Randomization will be stratified by sex and baseline BMI category (25.0-29.9 kg/m² versus 30.0-40.0 kg/m²).

Study Record Dates

• First Submitted: July 24, 2026
• First Posted: July 30, 2026
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): March 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: July 30, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Data will become available beginning 12 months after publication of the primary study results and will remain available for 5 years.
• Access Criteria: Requests must be submitted by qualified researchers and include a methodologically sound research proposal, analysis plan, requested data elements, and evidence of any required ethics approval. Requests will be reviewed by the study data-access committee for scientific merit, feasibility, compatibility with participant consent, protection of participant confidentiality, and compliance with legal and contractual requirements. Approved researchers must sign a data-use agreement specifying secure data handling, use only for the approved purpose, prohibition of participant re-identification and unauthorized onward sharing, and destruction or return of the data after completion of the approved research.

Locations

TU (1)