Overweight (Without Type 2 Diabetes) With Weight-related ComorbiditiesAIM-WEIGHTNCT07736547
AIM-WEIGHT: AI-Guided Microbiome-Targeted Nutritional Intervention for Weight Loss
A study testing AI-Guided Microbiome-Targeted Nutritional Supplement and Lifestyle counselling in people with Overweight (Without Type 2 Diabetes) With Weight-related Comorbidities and Overweight (BMI > 25), run by Varol TUNALI at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Overweight (Without Type 2 Diabetes) With Weight-related Comorbidities, Overweight (BMI > 25)
- What is being tested?
- AI-Guided Microbiome-Targeted Nutritional Supplement and Lifestyle counselling
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2026to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 13Show fewer
- 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.
Who cannot join
- 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.
Show all 28Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Başakşehir Çam and Sakura City Hospital
Istanbul
About this study
Official title: A Randomized, Double-blind, Placebo-Controlled, Parallel-Group Trial Evaluating an AI-Guided Microbiome-Targeted Nutritional Intervention for Weight Loss in Adults With Overweight or Obesity Without Prediabetes or Diabetes: The AIM-WEIGHT Trial
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.
Read the detailed description
AIM-WEIGHT is a randomized, masked, placebo-controlled, parallel-group proof-of-concept study designed to obtain an initial controlled estimate of the efficacy and safety of a fixed microbiome-targeted nutritional intervention for weight management. The study is intended to determine whether the observed treatment signal is sufficiently promising to support a larger confirmatory trial and to provide a more precise estimate of the treatment effect for future study planning.
The investigational formulation was selected before participant enrollment using an artificial-intelligence-guided formulation-development process. The AI methodology was used to inform the selection and dosing of candidate microbiome-active ingredients based on prior analyses of relationships between the gut microbiome and metabolic health. The resulting formulation is fixed and identical for all participants assigned to the active group. AI will not be used during the study for participant-level personalization, treatment assignment, dose modification, prediction, or clinical decision-making. Consequently, the study evaluates the clinical performance of the fixed formulation and is not designed as an independent validation of the AI algorithm.
The study includes a 12-week primary weight-loss period followed by continued assigned intervention through Week 24. The Week 24 assessments are intended to provide supportive evidence regarding maintenance of the Week 12 effect during continued treatment. They should not be interpreted as evaluating maintenance after treatment withdrawal.
The sample size is based on the primary endpoint of percentage change in body weight from baseline to Week 12. Assuming a between-group difference of 3.5 percentage points, a common standard deviation of 5.0 percentage points, and a two-sided significance level of 0.05, 34 evaluable participants per group provide approximately 81% statistical power. Allowing for approximately 15% attrition by Week 12, 80 participants will be randomized in total, with 40 assigned to each group. The primary analysis will compare randomized groups using analysis of covariance adjusted for baseline body weight and the prespecified randomization stratification factors.
- Conditions
- Overweight (Without Type 2 Diabetes) With Weight-related Comorbidities, Overweight (BMI > 25)
- Being tested
- AI-Guided Microbiome-Targeted Nutritional Supplement, Matching Placebo (B), Lifestyle counselling
- Keywords
- Obesity, Overwieght, Weight loss, Supplement, Artificial intelligence, Microbiome
- Medical subject headings
- Overweight, Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-Guided Microbiome-Targeted Nutritional SupplementDietary 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)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.
Lifestyle counsellingBehavioural
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Matching Placebo (B); Behavioral: Lifestyle counselling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to Week 12
Secondary outcomes (7)
Percent Change in Body Weight From Baseline to Week 24
Percent change in body weight will be calculated as 100 x [(Week 24 body weight - baseline body weight) / baseline body weight]. Negative values indicate weight loss. Body weight will be measured in kilograms using the same standardized fasting measurement procedure used for the primary outcome. This outcome represents the cumulative body-weight change during the complete 24-week assigned supplementation period.
Measured: Baseline to Week 24
Proportion of Participants Achieving at Least 5% Body-Weight Loss at Week 12
The proportion of participants whose Week 12 body weight is at least 5% lower than their baseline body weight will be determined. Percentage body-weight loss will be calculated as 100 x [(baseline body weight - Week 12 body weight) / baseline body weight]. Each participant will be classified as achieving or not achieving the 5% threshold.
Measured: Baseline to Week 12
Change in Waist Circumference From Baseline to Week 12
Change in waist circumference will be calculated as Week 12 waist circumference minus baseline waist circumference and reported in centimeters. Negative values indicate a reduction. Waist circumference will be measured using a non-stretch tape at the midpoint between the lowest rib and the iliac crest. Two measurements will be obtained. If they differ by no more than 1.0 cm, their mean will be used. If they differ by more than 1.0 cm, a third measurement will be obtained and the median of the three measurements will be used.
Measured: Baseline to Week 12
Proportion of Participants Achieving at Least 5% Body-Weight Loss at Week 24
The proportion of participants whose Week 24 body weight is at least 5% lower than their baseline body weight will be determined. Percentage body-weight loss will be calculated as 100 x [(baseline body weight - Week 24 body weight) / baseline body weight]. Each participant will be classified as achieving or not achieving the 5% threshold.
Measured: Baseline to Week 24
Change in Waist Circumference From Baseline to Week 24
Change in waist circumference will be calculated as Week 24 waist circumference minus baseline waist circumference and reported in centimeters. Negative values indicate a reduction. Waist circumference will be measured using the same standardized procedure used for the Week 12 waist-circumference outcome. This outcome represents cumulative change during the complete 24-week assigned supplementation period.
Measured: Baseline to Week 24
Change in Gut Microbiome Shannon Diversity Index From Baseline to Week 12
Gut microbiome alpha diversity will be calculated from shotgun metagenomic species-level relative abundance profiles using the Shannon diversity index. Change will be calculated as the Week 12 Shannon index minus the baseline Shannon index. Positive values indicate increased within-sample microbial diversity, and negative values indicate decreased within-sample diversity. Increased diversity will not necessarily be interpreted as clinical improvement. Week 12 is the principal exploratory microbiome time point and reflects exposure to the initial supplementation regimen.
Measured: Baseline to Week 12
Change in Gut Microbiome Community Composition From Baseline to Week 12
Overall gut microbiome community composition will be evaluated from shotgun metagenomic species-level abundance profiles using Bray-Curtis dissimilarity. Bray-Curtis values range from 0 to 1, with larger values indicating greater compositional dissimilarity; larger values do not indicate a better clinical outcome. Differences between randomized groups in community change from baseline to Week 12 will be evaluated using a prespecified longitudinal permutation-based multivariate analysis with permutations constrained by participant. Multivariate dispersion will also be assessed.
Measured: Baseline to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2026
- Study start1 Jul 2026
- Primary completion30 Mar 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight (Without Type 2 Diabetes) With Weight-related ComorbiditiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Varol TUNALI
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor-investigator, Varol TUNALI, ENBIOSIS BIOTECHNOLOGIES
- Investigators
- Varol TUNALI, Dr., Study director, Enbiosis Biotechnology Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07736547
- Sponsor's protocol ID
- Enbiosis_AIM-WEIGHT
- Acronym
- AIM-WEIGHT
- Status last verified
- Jul 2026
- First submitted
- 24 Jul 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the published primary and key secondary outcome results will be made available to qualified researchers following approval of a written request by the study data-access committee. Shared materials may include relevant clinical, safety, patient-reported outcome, and processed microbiome data, together with a data dictionary. Data will be shared only to the extent permitted by participant consent, applicable ethics approvals, and data-protection requirements. Information that could identify participants or disclose confidential product composition, manufacturing information, or proprietary AI methods will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-Controlled, Parallel-Group Trial Evaluating an AI-Guided Microbiome-Targeted Nutritional Intervention for Weight Loss in Adults With Overweight or Obesity Without Prediabetes or Diabetes: The AIM-WEIGHT Trial
- ClinicalTrials.gov ID
- NCT07736547
- Acronym / sponsor ID
- AIM-WEIGHT / Enbiosis_AIM-WEIGHT
- Conditions
- Overweight (Without Type 2 Diabetes) With Weight-related Comorbidities, Overweight (BMI > 25)
- Keywords
- Obesity, Overwieght, Weight loss, Supplement, Artificial intelligence, Microbiome
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Varol TUNALIIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2026 (actual)
- Primary completion
- 30 Mar 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 30 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
AIM-WEIGHT is a randomized, masked, placebo-controlled, parallel-group proof-of-concept study designed to obtain an initial controlled estimate of the efficacy and safety of a fixed microbiome-targeted nutritional intervention for weight management. The study is intended to determine whether the observed treatment signal is sufficiently promising to support a larger confirmatory trial and to provide a more precise estimate of the treatment effect for future study planning.
The investigational formulation was selected before participant enrollment using an artificial-intelligence-guided formulation-development process. The AI methodology was used to inform the selection and dosing of candidate microbiome-active ingredients based on prior analyses of relationships between the gut microbiome and metabolic health. The resulting formulation is fixed and identical for all participants assigned to the active group. AI will not be used during the study for participant-level personalization, treatment assignment, dose modification, prediction, or clinical decision-making. Consequently, the study evaluates the clinical performance of the fixed formulation and is not designed as an independent validation of the AI algorithm.
The study includes a 12-week primary weight-loss period followed by continued assigned intervention through Week 24. The Week 24 assessments are intended to provide supportive evidence regarding maintenance of the Week 12 effect during continued treatment. They should not be interpreted as evaluating maintenance after treatment withdrawal.
The sample size is based on the primary endpoint of percentage change in body weight from baseline to Week 12. Assuming a between-group difference of 3.5 percentage points, a common standard deviation of 5.0 percentage points, and a two-sided significance level of 0.05, 34 evaluable participants per group provide approximately 81% statistical power. Allowing for approximately 15% attrition by Week 12, 80 participants will be randomized in total, with 40 assigned to each group. The primary analysis will compare randomized groups using analysis of covariance adjusted for baseline body weight and the prespecified randomization stratification factors.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| AI-Guided Microbiome-Targeted Nutritional Intervention | Experimental | Dietary Supplement: AI-Guided Microbiome-Targeted Nutritional Supplement, Behavioral: Lifestyle counsellingParticipants 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. |
| Matching Placebo | Placebo comparator | Dietary Supplement: Matching Placebo (B), Behavioral: Lifestyle counsellingParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (28 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AI-Guided Microbiome-Targeted Nutritional SupplementA 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. | Dietary supplement | AI-Guided Microbiome-Targeted Nutritional Intervention |
| 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. | Dietary supplement | Matching Placebo |
| Lifestyle counsellingParticipants 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. | Behavioural | AI-Guided Microbiome-Targeted Nutritional Intervention, Matching Placebo |
Primary outcome
Percent Change in Body Weight From Baseline to Week 12
Time frame: 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.
7 secondary outcomes
Percent Change in Body Weight From Baseline to Week 24
Time frame: Baseline to Week 24
Proportion of Participants Achieving at Least 5% Body-Weight Loss at Week 12
Time frame: Baseline to Week 12
Change in Waist Circumference From Baseline to Week 12
Time frame: Baseline to Week 12
Proportion of Participants Achieving at Least 5% Body-Weight Loss at Week 24
Time frame: Baseline to Week 24
Change in Waist Circumference From Baseline to Week 24
Time frame: Baseline to Week 24
Change in Gut Microbiome Shannon Diversity Index From Baseline to Week 12
Time frame: Baseline to Week 12
Change in Gut Microbiome Community Composition From Baseline to Week 12
Time frame: Baseline to Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the published primary and key secondary outcome results will be made available to qualified researchers following approval of a written request by the study data-access committee. Shared materials may include relevant clinical, safety, patient-reported outcome, and processed microbiome data, together with a data dictionary. Data will be shared only to the extent permitted by participant consent, applicable ethics approvals, and data-protection requirements. Information that could identify participants or disclose confidential product composition, manufacturing information, or proprietary AI methods will not be shared.
Related trials for Overweight (Without Type 2 Diabetes) With Weight-related Comorbidities
RecruitingPhase 3
A Study to Evaluate Effect of AZD6234 as an Adjunct to Incretin-based Therapies in Adult Participants With Obesity or Overweight With Weight-related Comorbidity With or Without Type 2 Diabetes Mellitus
Obesity or Overweight, Weight-Related Comorbidity
RecruitingPhase 3
A Study to Evaluate Effect of AZD6234 in Adult Participants With Obesity or Overweight With Weight-related Comorbidity Without Type 2 Diabetes Mellitus
Obesity or Overweight
Recruiting
Lean Beef as Part of a Healthy Meal Plan in Adolescents With Polycystic Ovary Syndrome (PCOS)/Polyendocrine Metabolic Ovarian Syndrome (PMOS)
PCOS (Polycystic Ovary Syndrome), Obese Adolescents
Active, not recruitingPhase 3
A Study of Orforglipron (LY3502970) in Participants With Obesity or Overweight and at Least One Weight-Related Comorbidity
Obesity, Overweight
Not yet recruiting
Effectiveness of Combined GLP-1/GIP Dual Agonist Therapy and Structured Exercise on Skeletal Muscle Morphology, Quality, and Physical Function in Overweight and Obese Individuals
Obesity, Sarcopenia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Varol TUNALI, Dr. study director
Enbiosis Biotechnology Limited
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI-Guided Microbiome-Targeted Nutritional Supplement and Lifestyle counselling in people with Overweight (Without Type 2 Diabetes) With Weight-related Comorbidities and Overweight (BMI > 25), run by Varol TUNALI at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change in Body Weight From Baseline to Week 12 (time frame: Baseline to Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.