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. 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.
• 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.