Type 2 DiabetesAIM-METNCT07622628
AIM-MET: AI-Guided Microbiome-Targeted Nutrition for Glycemic Improvement in Type 2 Diabetes
A study testing Microbiome-targeted oral food supplement in people with Type 2 Diabetes and Diabetes Mellitus Type 2, run by ENBIOSIS BIOTECHNOLOGIES at 1 site in Turkey (Türkiye).
Trial summary
AIM-MET is a randomized clinical study testing whether a fixed microbiome-targeted nutritional product can improve blood sugar control in adults with type 2 diabetes when used in addition to usual stable diabetes treatment. The study will compare the active nutritional product with a matching placebo over 24 weeks. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type 2 Diabetes, Diabetes Mellitus Type 2
- What is being tested?
- Microbiome-targeted oral food supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 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
- Adults aged 18 to 65 years.
- Established diagnosis of type 2 diabetes mellitus documented in the medical record, supported by American Diabetes Association diagnostic criteria on at least one prior occasion.
- HbA1c 6.8% to 8.2% at screening, measured by an NGSP-certified central laboratory assay; confirmed on a repeat sample if discordant with prior records or if the screening value is at the upper or lower boundary.
- Body mass index 18.5 to 40.0 kg/m2 at screening.
- Stable background glucose-lowering therapy for at least 3 months before randomization, restricted to metformin, a DPP-4 inhibitor, and/or an SGLT2 inhibitor, either alone or in combination.
- Documented body-weight stability, defined as no more than +/-5% or +/-3 kg, whichever is smaller, self-reported body-weight change during the 3 months before screening.
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- Willing and able to provide written informed consent.
- Willing and able to comply with trial visits, study product use, fasting blood sampling, stool sampling, and the study assessment schedule.
- Willing to receive standardized lifestyle counselling during the 24-week blinded period and to maintain stable background diabetes management as clinically directed.
- No systemic antibiotic use within 8 weeks before randomization.
- No probiotic, prebiotic, synbiotic, or postbiotic supplement use within 8 weeks before randomization.
- Stable hypertension, dyslipidaemia, and stable thyroid replacement therapy are permitted if medication has been initiated and the dose unchanged for at least 3 months before randomization.
Who cannot join
- Type 1 diabetes, latent autoimmune diabetes of adults, pancreatogenic diabetes, maturity-onset diabetes of the young, gestational diabetes as the current diagnosis, or any non-type-2 form of diabetes.
- HbA1c less than 6.8% or greater than 8.2% at screening.
- Current use of GLP-1 receptor agonists or GLP-1/GIP co-agonists, or use within 12 months before randomization.
- Current use of basal, prandial, or premixed insulin, or any insulin use within 6 months before randomization.
- Current use of sulfonylureas or meglitinides, or use within 3 months before randomization.
- Current use of anti-obesity pharmacotherapy or use within 6 months before randomization, including orlistat, naltrexone/bupropion, phentermine/topiramate, or other agents with a primary anti-obesity indication.
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- Recurrent severe hypoglycaemia or hypoglycaemia unawareness.
- Planned initiation or dose escalation of glucose-lowering medication, anti-obesity medication, or systemic corticosteroids during the 24-week trial period in the judgment of the treating clinician.
- History of bariatric surgery at any time.
- Gastrointestinal surgery other than appendectomy or uncomplicated cholecystectomy.
- Active inflammatory bowel disease, coeliac disease, microscopic colitis, chronic pancreatitis, malabsorption syndrome, or chronic severe gastrointestinal disease likely to affect absorption or trial adherence.
- Acute gastroenteritis within 4 weeks before randomization.
- Colonoscopy bowel preparation within 12 weeks before randomization.
- Faecal microbiota transplantation within 12 months before randomization.
- Active or recent malignancy within 6 months, except adequately treated non-melanoma skin cancer.
- Stage 3b to 5 chronic kidney disease, defined as estimated glomerular filtration rate less than 45 mL/min/1.73 m2.
- Decompensated liver disease or Child-Pugh class B/C.
- ALT or AST greater than 3 times the upper limit of normal at screening, unless judged clinically insignificant and approved by the investigator.
- Known or suspected haemoglobinopathy that materially distorts HbA1c measurement or haemoglobin variant known to interfere with the central laboratory assay.
- Blood transfusion, significant blood loss greater than 250 mL, or erythropoiesis-stimulating agent therapy within 3 months before randomization.
- Untreated overt thyroid disease, or thyroid medication initiation or dose change within 3 months before randomization.
- Use of systemic corticosteroids within 4 weeks before randomization.
- Use of immunosuppressive medication or biologic/immunomodulatory therapy within 5 half-lives before randomization.
- Pregnancy or lactation; women of childbearing potential not willing to use effective contraception during the 24-week blinded period.
- Severe psychiatric illness or cognitive impairment that may compromise informed consent, safety, or adherence.
- Active eating disorder, defined operationally as a positive SCOFF screen with at least 2 affirmative responses at screening, or clinical diagnosis of anorexia nervosa, bulimia nervosa, or binge-eating disorder.
- Heavy alcohol use or active substance use disorder.
- Current very-low-calorie diet, ketogenic diet, medically supervised weight-loss diet, or other highly restrictive diet that excludes major food groups.
- Current cigarette smoking with intention to attempt cessation during the 24-week trial period; current users of nicotine-replacement or smoking-cessation pharmacotherapy initiated within 3 months before randomization.
- Participation in another interventional clinical trial within 30 days before screening.
- Known hypersensitivity or clinically significant intolerance to any component of the active product or placebo.
- Inability or unwillingness to provide stool samples.
- Any condition that, in the investigator's opinion, would compromise participant safety or trial 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, 1 recruiting
- Recruiting
Bakırçay University Faculty of Medicine Endocrinology Department
Izmir
Sedat Güney, Dr., +90 554 844 92 66, sedat.guney@cbu.edu.tr
About this study
Official title: A 24-Week Randomized, Masked, Placebo-Controlled Trial of an AI-Guided Microbiome-Targeted Nutritional Intervention for Glycemic Improvement in Adults With Type 2 Diabetes: The AIM-MET Trial
AIM-MET is a randomized clinical study testing whether a fixed microbiome-targeted nutritional product can improve blood sugar control in adults with type 2 diabetes when used in addition to usual stable diabetes treatment.
The study will compare the active nutritional product with a matching placebo over 24 weeks. The product was designed using artificial intelligence before the study began, but the same fixed formulation will be used for all participants assigned to the active group. Artificial intelligence will not be used during the study to make individual treatment decisions, adjust dosing, or personalize the product.
Read more
The main question is whether participants receiving the active product have a greater reduction in HbA1c, a standard marker of average blood sugar levels, from the start of the study to Week 24 compared with participants receiving placebo. The study will also evaluate early blood sugar changes, fasting glucose, body weight and waist measurements in participants with baseline BMI of at least 25.0 kg/m2, safety, hypoglycaemia events, patient-reported outcomes, and gut microbiome features.
This is a 100-participant proof-of-concept study intended to estimate the size of the treatment signal, safety, feasibility, and parameters needed for a future larger confirmatory trial.
Read the detailed description
Type 2 diabetes is commonly managed with lifestyle measures and glucose-lowering medications, but many individuals continue to have residual hyperglycaemia despite stable treatment. Nutritional interventions that target the gut microbiome may provide a safe adjunctive approach if they can improve glycaemic control without replacing standard diabetes care.
The gut microbiome may influence glucose regulation through several biological pathways, including short-chain fatty acid production, bile acid metabolism, intestinal barrier function, low-grade inflammation, incretin signalling, and other host-microbe interactions. These mechanisms provide the rationale for evaluating a microbiome-targeted nutritional intervention in adults with type 2 diabetes.
The investigational product is a fixed AI-guided microbiome-targeted nutritional formulation. The artificial intelligence methodology was used before the clinical trial to support formulation design, including ingredient and dose selection from candidate microbiome-active compounds. The output of this process is one fixed formulation that is locked before participant enrolment and is identical for all participants assigned to the active intervention arm. The artificial intelligence system is not used during the trial for participant-level prediction, diagnosis, clinical decision-making, dosing, personalization, or formulation adjustment. Therefore, the clinical study evaluates the fixed nutritional product, not the independent clinical performance of an artificial intelligence system.
Participants are randomized in a 1:1 ratio to receive either the active nutritional intervention or a matching placebo for 24 weeks. Both groups receive identical structured lifestyle counselling and continue stable background glucose-lowering therapy as clinically appropriate. The placebo is matched to the active product in appearance, taste, smell, packaging, administration schedule, and storage conditions, and is intended to be microbiome- and glycaemia-neutral.
The primary clinical assessment is the change in HbA1c from baseline to Week 24. Week 24 was selected because HbA1c reflects average glycaemia over the preceding 2 to 3 months and is therefore appropriate for evaluating a gradually acting nutritional and microbiome-targeted intervention. The study also evaluates supportive glycaemic, anthropometric, safety, patient-reported, and microbiome-related measures.
This 100-participant proof-of-concept trial is designed to detect a clinically meaningful HbA1c signal and to estimate safety, feasibility, variability, and effect-size parameters for a future larger confirmatory trial. The study is not intended to replace standard diabetes care or to assess the investigational product as a substitute for clinically indicated glucose-lowering medication.
- Conditions
- Type 2 Diabetes, Diabetes Mellitus Type 2
- Being tested
- Microbiome-targeted oral food supplement, Matching placebo oral supplement
- Keywords
- Type 2 diabetes, Type 2 diabetes mellitus, HbA1c, Glycemic response, Glycemic control, Microbiome, Gut microbiome, Nutritional intervention, AI-guided formulation design, Artificial intelligence, Randomized controlled trial, AIM-MET
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microbiome-targeted oral food supplementDietary supplement
Also called AIM-MET active intervention, AI-guided microbiome-targeted nutritional intervention
Fixed AI-guided microbiome-targeted oral food supplement administered for 24 weeks. The formulation is fixed and identical for all participants randomized to the active intervention arm. The artificial intelligence methodology was used before the trial for formulation design only and is not used during the trial for participant-level prediction, dosing, clinical decision-making, or formulation adjustment. Participants also receive identical structured lifestyle counselling and continue stable permitted background glucose-lowering therapy as clinically appropriate.
Matching placebo oral supplementDietary supplement
Matching placebo oral supplement administered for 24 weeks. The placebo is matched to the active product in appearance, taste, smell, packaging, administration schedule, and storage conditions. The placebo is intended to be microbiome- and glycaemia-neutral and free of active prebiotic, probiotic, synbiotic, postbiotic, glycaemically active, or other bioactive components reasonably expected to affect HbA1c, fasting plasma glucose, body weight, microbiome composition, or inflammatory markers. Participants also receive identical structured lifestyle counselling and continue stable permitted background glucose-lowering therapy as clinically appropriate.
| Study group | Role | What they receive |
|---|---|---|
| Microbiome-targeted oral food supplement | Experimental | Fixed AI-guided microbiome-targeted oral food supplement administered orally once daily for 24 weeks as one sachet plus one capsule. The formulation is fixed and identical for all participants randomized to the active intervention arm. The proprietary formulation was reviewed as part of the ethics committee submission and is locked before participant enrolment. The artificial intelligence methodology was used before the trial for formulation design only and is not used during the trial for participant-level prediction, dosing, clinical decision-making, or formulation adjustment. Receives: Dietary Supplement: Microbiome-targeted oral food supplement |
| Matching placebo oral supplement | Placebo comparator | Matching placebo oral supplement administered orally once daily for 24 weeks as one sachet plus one capsule. The placebo is matched to the active product in appearance, taste, smell, packaging, administration schedule, and storage conditions. The placebo is intended to be microbiome- and glycaemia-neutral and free of active prebiotic, probiotic, synbiotic, postbiotic, glycaemically active, or other bioactive components reasonably expected to affect HbA1c, fasting plasma glucose, body weight, microbiome composition, or inflammatory markers. Receives: Dietary Supplement: Matching placebo oral supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c from baseline to Week 24
HbA1c is a blood test that reflects average blood glucose levels over approximately the previous 2 to 3 months. HbA1c is measured using an NGSP-certified central laboratory assay and reported as a percentage. The outcome is the absolute change in HbA1c, in percentage points, from baseline to Week 24. A greater reduction indicates improved glycaemic control.
Measured: Baseline to Week 24
Secondary outcomes (7)
Proportion of participants achieving HbA1c reduction of at least 0.5 percentage points at Week 24
This outcome measures the proportion of participants whose HbA1c decreases by at least 0.5 percentage points from baseline to Week 24. HbA1c is a blood test reflecting average glucose levels over approximately 2 to 3 months and is measured using an NGSP-certified central laboratory assay. Participants who meet or exceed this reduction threshold are counted as responders.
Measured: Baseline to Week 24
Proportion of participants achieving HbA1c reduction of at least 0.3 percentage points at Week 24
This outcome measures the proportion of participants whose HbA1c decreases by at least 0.3 percentage points from baseline to Week 24. HbA1c is measured using an NGSP-certified central laboratory assay and reported as a percentage. Participants who meet or exceed this reduction threshold are counted as responders.
Measured: Baseline to Week 24
Change in HbA1c from baseline to Week 12
HbA1c is a blood test that reflects average blood glucose levels over approximately the previous 2 to 3 months. This outcome measures the absolute change in HbA1c, in percentage points, from baseline to Week 12. This earlier time point is used to describe the early trajectory of glycaemic response.
Measured: Baseline to Week 12
Change in fasting plasma glucose from baseline to Week 24
Fasting plasma glucose is a blood measure of glucose concentration after an overnight fast of at least 8 hours. Baseline and Week 24 values are each defined as the mean of two fasting plasma glucose samples drawn within a 7-day window. The outcome is the absolute change from baseline to Week 24. A greater reduction indicates improved fasting glycaemia.
Measured: Baseline to Week 24
Achievement of HbA1c less than 7.0% at Week 24 among participants with baseline HbA1c at least 7.0%
This outcome measures the proportion of participants with baseline HbA1c of at least 7.0% who achieve HbA1c less than 7.0% at Week 24. HbA1c is measured using an NGSP-certified central laboratory assay and reported as a percentage. Participants below the 7.0% threshold at Week 24 are counted as achieving this outcome.
Measured: Baseline to Week 24
Percent change in body weight at Week 24 in participants with baseline BMI at least 25.0 kg/m2
This outcome is assessed only in participants with baseline body mass index, or BMI, of at least 25.0 kg/m2. Body weight is measured using a standardized calibrated scale procedure. Percent change is calculated as 100 x (Week 24 body weight - baseline body weight) / baseline body weight. A negative value indicates weight reduction.
Measured: Baseline to Week 24
Change in waist circumference at Week 24 in participants with baseline BMI at least 25.0 kg/m2
This outcome is assessed only in participants with baseline BMI of at least 25.0 kg/m2. Waist circumference is measured using a standardized non-stretch tape procedure. The outcome is the absolute change in waist circumference from baseline to Week 24, reported in centimeters. A negative value indicates a reduction in waist circumference.
Measured: Baseline to Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2026
- Study start1 Jun 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 Type 2 DiabetesStudies 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
- Participants are randomized 1:1 to active intervention or matching placebo for 24 weeks. Both arms receive identical structured lifestyle counselling and continue stable permitted background glucose-lowering therapy as clinically appropriate. Randomization is stratified by sex, baseline HbA1c category, baseline SGLT2 inhibitor use, and baseline BMI category.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ENBIOSIS BIOTECHNOLOGIES
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bakırçay University, Faculty of Medicine, Aydin Adnan Menderes University, Buca Seyfi Demirsoy State Hospital, Izmir University of Economics
- Responsible party
- Principal investigator, Varol TUNALI, ENBIOSIS BIOTECHNOLOGIES
- Investigators
- Engin Güney, Prof. Dr., Study chair, Aydın Adnan Menderes University Faculty of Medicine Endocrinology DepartmentVarol Tunali, Dr., Principal investigator, Enbiosis Biotechnology Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07622628
- Sponsor's protocol ID
- Enbiosis_AIM-MET
- Acronym
- AIM-MET
- Status last verified
- May 2026
- First submitted
- 28 May 2026
- Last updated
- 28 Jul 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 may be made available after publication upon reasonable request and approval by the sponsor data-access committee. Shared data may include de-identified participant-level clinical, safety, and patient-reported outcome data needed to reproduce the main published analyses. Microbiome sequencing data may be deposited or shared with minimized metadata to reduce re-identification risk, subject to participant consent and applicable data-protection regulations.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 24-Week Randomized, Masked, Placebo-Controlled Trial of an AI-Guided Microbiome-Targeted Nutritional Intervention for Glycemic Improvement in Adults With Type 2 Diabetes: The AIM-MET Trial
- ClinicalTrials.gov ID
- NCT07622628
- Acronym / sponsor ID
- AIM-MET / Enbiosis_AIM-MET
- Conditions
- Type 2 Diabetes, Diabetes Mellitus Type 2
- Keywords
- Type 2 diabetes, Type 2 diabetes mellitus, HbA1c, Glycemic response, Glycemic control, Microbiome, Gut microbiome, Nutritional intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- ENBIOSIS BIOTECHNOLOGIESIndustry (pharma, biotech, devices)
- Collaborators
- Bakırçay University, Faculty of Medicine, Aydin Adnan Menderes University, Buca Seyfi Demirsoy State Hospital, Izmir University of Economics
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 30 Mar 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 3 Jun 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-MET is a randomized clinical study testing whether a fixed microbiome-targeted nutritional product can improve blood sugar control in adults with type 2 diabetes when used in addition to usual stable diabetes treatment.
The study will compare the active nutritional product with a matching placebo over 24 weeks. The product was designed using artificial intelligence before the study began, but the same fixed formulation will be used for all participants assigned to the active group. Artificial intelligence will not be used during the study to make individual treatment decisions, adjust dosing, or personalize the product.
The main question is whether participants receiving the active product have a greater reduction in HbA1c, a standard marker of average blood sugar levels, from the start of the study to Week 24 compared with participants receiving placebo. The study will also evaluate early blood sugar changes, fasting glucose, body weight and waist measurements in participants with baseline BMI of at least 25.0 kg/m2, safety, hypoglycaemia events, patient-reported outcomes, and gut microbiome features.
This is a 100-participant proof-of-concept study intended to estimate the size of the treatment signal, safety, feasibility, and parameters needed for a future larger confirmatory trial.
Detailed description
Type 2 diabetes is commonly managed with lifestyle measures and glucose-lowering medications, but many individuals continue to have residual hyperglycaemia despite stable treatment. Nutritional interventions that target the gut microbiome may provide a safe adjunctive approach if they can improve glycaemic control without replacing standard diabetes care.
The gut microbiome may influence glucose regulation through several biological pathways, including short-chain fatty acid production, bile acid metabolism, intestinal barrier function, low-grade inflammation, incretin signalling, and other host-microbe interactions. These mechanisms provide the rationale for evaluating a microbiome-targeted nutritional intervention in adults with type 2 diabetes.
The investigational product is a fixed AI-guided microbiome-targeted nutritional formulation. The artificial intelligence methodology was used before the clinical trial to support formulation design, including ingredient and dose selection from candidate microbiome-active compounds. The output of this process is one fixed formulation that is locked before participant enrolment and is identical for all participants assigned to the active intervention arm. The artificial intelligence system is not used during the trial for participant-level prediction, diagnosis, clinical decision-making, dosing, personalization, or formulation adjustment. Therefore, the clinical study evaluates the fixed nutritional product, not the independent clinical performance of an artificial intelligence system.
Participants are randomized in a 1:1 ratio to receive either the active nutritional intervention or a matching placebo for 24 weeks. Both groups receive identical structured lifestyle counselling and continue stable background glucose-lowering therapy as clinically appropriate. The placebo is matched to the active product in appearance, taste, smell, packaging, administration schedule, and storage conditions, and is intended to be microbiome- and glycaemia-neutral.
The primary clinical assessment is the change in HbA1c from baseline to Week 24. Week 24 was selected because HbA1c reflects average glycaemia over the preceding 2 to 3 months and is therefore appropriate for evaluating a gradually acting nutritional and microbiome-targeted intervention. The study also evaluates supportive glycaemic, anthropometric, safety, patient-reported, and microbiome-related measures.
This 100-participant proof-of-concept trial is designed to detect a clinically meaningful HbA1c signal and to estimate safety, feasibility, variability, and effect-size parameters for a future larger confirmatory trial. The study is not intended to replace standard diabetes care or to assess the investigational product as a substitute for clinically indicated glucose-lowering medication.
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
- Participants are randomized 1:1 to active intervention or matching placebo for 24 weeks. Both arms receive identical structured lifestyle counselling and continue stable permitted background glucose-lowering therapy as clinically appropriate. Randomization is stratified by sex, baseline HbA1c category, baseline SGLT2 inhibitor use, and baseline BMI category.
| Arm | Type | Receives |
|---|---|---|
| Microbiome-targeted oral food supplement | Experimental | Dietary Supplement: Microbiome-targeted oral food supplementFixed AI-guided microbiome-targeted oral food supplement administered orally once daily for 24 weeks as one sachet plus one capsule. The formulation is fixed and identical for all participants randomized to the active intervention arm. The proprietary formulation was reviewed as part of the ethics committee submission and is locked before participant enrolment. The artificial intelligence methodology was used before the trial for formulation design only and is not used during the trial for participant-level prediction, dosing, clinical decision-making, or formulation adjustment. |
| Matching placebo oral supplement | Placebo comparator | Dietary Supplement: Matching placebo oral supplementMatching placebo oral supplement administered orally once daily for 24 weeks as one sachet plus one capsule. The placebo is matched to the active product in appearance, taste, smell, packaging, administration schedule, and storage conditions. The placebo is intended to be microbiome- and glycaemia-neutral and free of active prebiotic, probiotic, synbiotic, postbiotic, glycaemically active, or other bioactive components reasonably expected to affect HbA1c, fasting plasma glucose, body weight, microbiome composition, or inflammatory markers. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Adults aged 18 to 65 years.
- Established diagnosis of type 2 diabetes mellitus documented in the medical record, supported by American Diabetes Association diagnostic criteria on at least one prior occasion.
- HbA1c 6.8% to 8.2% at screening, measured by an NGSP-certified central laboratory assay; confirmed on a repeat sample if discordant with prior records or if the screening value is at the upper or lower boundary.
- Body mass index 18.5 to 40.0 kg/m2 at screening.
- Stable background glucose-lowering therapy for at least 3 months before randomization, restricted to metformin, a DPP-4 inhibitor, and/or an SGLT2 inhibitor, either alone or in combination.
Key exclusion criteria (33 listed)
- Type 1 diabetes, latent autoimmune diabetes of adults, pancreatogenic diabetes, maturity-onset diabetes of the young, gestational diabetes as the current diagnosis, or any non-type-2 form of diabetes.
- HbA1c less than 6.8% or greater than 8.2% at screening.
- Current use of GLP-1 receptor agonists or GLP-1/GIP co-agonists, or use within 12 months before randomization.
- Current use of basal, prandial, or premixed insulin, or any insulin use within 6 months before randomization.
- Current use of sulfonylureas or meglitinides, or use within 3 months before randomization.
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 |
|---|---|---|
| Microbiome-targeted oral food supplementAlso: AIM-MET active intervention, AI-guided microbiome-targeted nutritional interventionFixed AI-guided microbiome-targeted oral food supplement administered for 24 weeks. The formulation is fixed and identical for all participants randomized to the active intervention arm. The artificial intelligence methodology was used before the trial for formulation design only and is not used during the trial for participant-level prediction, dosing, clinical decision-making, or formulation adjustment. Participants also receive identical structured lifestyle counselling and continue stable permitted background glucose-lowering therapy as clinically appropriate. | Dietary supplement | Microbiome-targeted oral food supplement |
| Matching placebo oral supplementMatching placebo oral supplement administered for 24 weeks. The placebo is matched to the active product in appearance, taste, smell, packaging, administration schedule, and storage conditions. The placebo is intended to be microbiome- and glycaemia-neutral and free of active prebiotic, probiotic, synbiotic, postbiotic, glycaemically active, or other bioactive components reasonably expected to affect HbA1c, fasting plasma glucose, body weight, microbiome composition, or inflammatory markers. Participants also receive identical structured lifestyle counselling and continue stable permitted background glucose-lowering therapy as clinically appropriate. | Dietary supplement | Matching placebo oral supplement |
Primary outcome
Change in HbA1c from baseline to Week 24
Time frame: Baseline to Week 24
HbA1c is a blood test that reflects average blood glucose levels over approximately the previous 2 to 3 months. HbA1c is measured using an NGSP-certified central laboratory assay and reported as a percentage. The outcome is the absolute change in HbA1c, in percentage points, from baseline to Week 24. A greater reduction indicates improved glycaemic control.
7 secondary outcomes
Proportion of participants achieving HbA1c reduction of at least 0.5 percentage points at Week 24
Time frame: Baseline to Week 24
Proportion of participants achieving HbA1c reduction of at least 0.3 percentage points at Week 24
Time frame: Baseline to Week 24
Change in HbA1c from baseline to Week 12
Time frame: Baseline to Week 12
Change in fasting plasma glucose from baseline to Week 24
Time frame: Baseline to Week 24
Achievement of HbA1c less than 7.0% at Week 24 among participants with baseline HbA1c at least 7.0%
Time frame: Baseline to Week 24
Percent change in body weight at Week 24 in participants with baseline BMI at least 25.0 kg/m2
Time frame: Baseline to Week 24
Change in waist circumference at Week 24 in participants with baseline BMI at least 25.0 kg/m2
Time frame: Baseline to Week 24
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 28 Jul 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the published primary and key secondary outcome results may be made available after publication upon reasonable request and approval by the sponsor data-access committee. Shared data may include de-identified participant-level clinical, safety, and patient-reported outcome data needed to reproduce the main published analyses. Microbiome sequencing data may be deposited or shared with minimized metadata to reduce re-identification risk, subject to participant consent and applicable data-protection regulations.
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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.
Engin Güney, Prof. Dr. study chair
Aydın Adnan Menderes University Faculty of Medicine Endocrinology Department
Varol Tunali, Dr. principal investigator
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 Microbiome-targeted oral food supplement in people with Type 2 Diabetes and Diabetes Mellitus Type 2, run by ENBIOSIS BIOTECHNOLOGIES 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 12 inclusion and 33 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: looking for participants now, as of the sponsor's last update on 28 Jul 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?
Contact Varol TUNALI, Dr. (+905556303231, vtunali@enbiosis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in HbA1c from baseline to Week 24 (time frame: Baseline to Week 24). 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 28 Jul 2026.