AIM-MET: AI-Guided Microbiome-Targeted Nutrition for Glycemic Improvement in Type 2 Diabetes

NCT07622628 | Recruiting

• 1 other identifier: Enbiosis_AIM-MET
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 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.

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; AI-guided formulation design; Artificial intelligence; Randomized controlled trial; AIM-MET

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline to Week 24

Secondary Outcomes (7)

• Proportion of participants achieving HbA1c reduction of at least 0.5 percentage points at Week 24

  Baseline to Week 24

• Proportion of participants achieving HbA1c reduction of at least 0.3 percentage points at Week 24

  Baseline to Week 24

• Change in HbA1c from baseline to Week 12

  Baseline to Week 12

• Change in fasting plasma glucose from baseline to Week 24

  Baseline to Week 24

• Achievement of HbA1c less than 7.0% at Week 24 among participants with baseline HbA1c at least 7.0%

  Baseline to Week 24

Other Outcomes (9)

• Change in fasting plasma glucose from baseline to Week 12

  Baseline to Week 12

• Achievement of HbA1c less than 6.5% at Week 24

  Baseline to Week 24

• Absolute change in body weight at Week 12 and Week 24 by BMI subgroup

  Baseline to Week 12 and Week 24

Study Arms (2)

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.

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.

Dietary Supplement: Matching placebo oral supplement

Interventions

Microbiome-targeted oral food supplement DIETARY_SUPPLEMENT

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.

Also known as: AIM-MET active intervention, AI-guided microbiome-targeted nutritional intervention

Microbiome-targeted oral food supplement

Matching placebo oral supplement DIETARY_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.

Matching placebo oral supplement

Eligibility Criteria

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

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• ENBIOSIS BIOTECHNOLOGIES: lead
• Bakırçay University, Faculty of Medicine: collaborator
• Aydin Adnan Menderes University: collaborator
• Buca Seyfi Demirsoy State Hospital: collaborator
• Izmir University of Economics: collaborator

Study Sites (1)

Bakırçay University Faculty of Medicine Endocrinology Department

Izmir, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Engin Güney, Prof. Dr.

  Aydın Adnan Menderes University Faculty of Medicine Endocrinology Department

  STUDY CHAIR

• Varol Tunali, Dr.

  Enbiosis Biotechnology Limited

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Varol TUNALI, Dr.

CONTACT

+905556303231; vtunali@enbiosis.com

Buğra Yağmur, Mr

CONTACT

+90 505 632 82 82; byagmur@enbiosis.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants, care providers, investigators, and outcome assessors remain masked to allocation throughout the 24-week treatment period. Laboratory staff performing primary and key secondary outcome assessments and the statistician performing the primary analysis remain masked until database lock and locking of the Statistical Analysis Plan-defined primary analysis. Active intervention and placebo are matched for appearance, taste, smell, packaging, administration schedule, and storage conditions. Emergency unblinding is permitted only when knowledge of allocation is essential for participant management.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Medical Officer (CMO)

Model Details: 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.

Study Record Dates

• First Submitted: May 28, 2026
• First Posted: June 3, 2026
• Study Start: June 8, 2026
• Primary Completion (Estimated): March 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: June 9, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Beginning 12 months after publication of the primary trial results and ending 5 years after publication.
• Access Criteria: Requests will be reviewed by the sponsor data-access committee. Requestors must provide a methodologically sound research proposal, a statistical analysis plan, and a signed data-use agreement. Data will be shared only for approved scientific purposes and in accordance with participant consent, applicable ethics approvals, and data-protection regulations.

Locations

TU (1)