An interventional study of AI-Guided Microbiome-Targeted Nutritional Supplement and Matching Placebo (B) in Overweight (Without Type 2 Diabetes) With Weight-related Comorbidities and Overweight (BMI > 25), sponsored by Varol TUNALI. Enrolling by invitation at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-29.
Sponsored by Varol TUNALI · Not applicable, Interventional, and Supportive care
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.
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.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's planned enrollment of 80 is above the median of 67 across 9,006 interventional studies indexed under Obesity.
Browse Obesity studies →Varol TUNALI is the lead sponsor of 4 studies on the registry; 3 are open to participants now.
Compared within Obesity, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Overweight. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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.
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.
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.
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.
Time frame: Baseline to Week 12
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline to Week 12
Percent Change in Body Weight From Week 12 to Week 24 During Maintenance Supplementation
Percent change in body weight during the maintenance-supplementation period will be calculated as 100 x \[(Week 24 body weight - Week 12 body weight) / Week 12 body weight\]. Positive values indicate weight regain or weight increase after Week 12, negative values indicate further weight loss, and values near zero indicate little change. This is a supportive weight-trajectory outcome and does not estimate the independent causal effect of maintenance supplementation.
Time frame: Week 12 to Week 24
Proportion of Participants Achieving at Least 5% Body-Weight Loss at Both Week 12 and Week 24
The proportion of all randomized participants whose body weight is at least 5% below baseline at both Week 12 and Week 24 will be determined. Participants must meet the 5% threshold at both scheduled assessments to be classified as sustained responders. This outcome describes weight loss sustained at the two assessment visits and does not imply uninterrupted maintenance between visits.
Time frame: Baseline through Week 24
Absolute Change in Body Weight From Baseline at Weeks 12 and 24
Absolute change in body weight will be calculated as follow-up body weight minus baseline body weight and reported in kilograms at Week 12 and Week 24. Negative values indicate weight loss. Body weight will be measured using the standardized fasting measurement procedure specified for the primary outcome.
Time frame: Baseline to Weeks 12 and 24
Change in WHO-5 Well-Being Index Total Score From Baseline to Week 12
The WHO-5 Well-Being Index is a five-item self-report measure of mental well-being during the preceding two weeks. Each item is scored from 0 to 5. Item scores are summed to produce a raw total score from 0 to 25 and multiplied by four to produce a transformed total score from 0 to 100. Higher scores indicate better mental well-being. Change will be calculated as the Week 12 transformed total score minus the baseline transformed total score. Positive values indicate improvement.
Time frame: Baseline to Week 12
Change in WHO-5 Well-Being Index Total Score From Baseline to Week 24
The WHO-5 Well-Being Index transformed total score ranges from 0 to 100, with higher scores indicating better mental well-being. Change will be calculated as the Week 24 transformed total score minus the baseline transformed total score. Positive values indicate improvement. Only the total score will be analysed; the five individual items will not be treated as separate outcomes.
Time frame: Baseline to Week 24
Change in Impact of Weight on Self-Perception Total Score From Baseline to Week 12
The Impact of Weight on Self-Perception Questionnaire is a three-item self-report measure assessing the effect of body weight on appearance-related dissatisfaction and self-consciousness. Items are scored from 1 to 5 and averaged. The mean item score is transformed to a scale from 0 to 100, with higher scores indicating better weight-related self-perception. Change will be calculated as the Week 12 total score minus the baseline total score. Positive values indicate improvement. Only the total score will be analysed.
Time frame: Baseline to Week 12
Change in Impact of Weight on Self-Perception Total Score From Baseline to Week 24
The Impact of Weight on Self-Perception total score ranges from 0 to 100, with higher scores indicating better weight-related self-perception. Change will be calculated as the Week 24 total score minus the baseline total score. Positive values indicate improvement. Only the total score will be analysed; individual questionnaire items will not be treated as separate outcomes.
Time frame: Baseline to Week 24
Differential Change in Gut Microbial Species Abundance From Baseline to Week 12
Shotgun metagenomic sequencing will be used to estimate species-level relative microbial abundance. Species meeting prespecified prevalence and abundance criteria will be evaluated for differential change between randomized groups from baseline to Week 12 using a compositional repeated-measures method. Results will be reported as model-based abundance differences or fold changes with confidence intervals. False-discovery-rate correction will be applied across the tested species, with adjusted q values below 0.05 considered statistically significant.
Time frame: Baseline to Week 12
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, 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.
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