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

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

Interventions

DIETARY_SUPPLEMENT

Microbiome-targeted oral food 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.

DIETARY_SUPPLEMENT

Matching placebo oral 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.

Sponsors & Collaborators

• Bakırçay University, Faculty of Medicine

  collaborator UNKNOWN

• Aydin Adnan Menderes University

  collaborator OTHER

• Buca Seyfi Demirsoy State Hospital

  collaborator OTHER

• Izmir University of Economics

  collaborator OTHER

• ENBIOSIS BIOTECHNOLOGIES

  lead INDUSTRY

Principal Investigators

• Engin Güney, Prof. Dr. · Aydın Adnan Menderes University Faculty of Medicine Endocrinology Department

• Varol Tunali, Dr. · Enbiosis Biotechnology Limited

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-06-01

Primary Completion

2027-03-30

Completion

2027-06-30

Countries

• Turkey (Türkiye)

Study Locations