24-Week Randomized Trial of an AI-Designed Nutritional Supplement to Improve Blood Sugar Control in Adults with Type 2 Diabetes

What this Trial Is About

Researchers are evaluating a fixed microbiome-targeted nutritional product designed using artificial intelligence to improve blood sugar control in adults with type 2 diabetes. This proof-of-concept study aims to estimate the treatment effect size, safety, and feasibility over 24 weeks, comparing the active nutritional product with a matching placebo. The trial involves 100 participants aged 18 to 65 years who continue their usual stable diabetes treatment throughout the study. Participants are randomly assigned to receive either the AI-guided microbiome-targeted oral food supplement or a matching placebo daily for 24 weeks. Both groups receive identical lifestyle counseling and maintain stable glucose-lowering therapy. The investigational product consists of one sachet plus one capsule taken orally each day, while the placebo matches the active product in appearance and administration but is designed to be microbiome- and glycaemia-neutral. Throughout the study, participants attend visits for assessments including blood tests measuring HbA1c and fasting glucose, body weight and waist measurements for those with higher BMI, safety monitoring, stool sample collection for gut microbiome analysis, and patient-reported outcome questionnaires. The main outcome is the change in HbA1c from baseline to Week 24, with additional evaluations at Week 12 and other related measures. Participation lasts 24 weeks, during which adherence to study product use and lifestyle counseling is monitored.

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