A multimodal lifestyle intervention program targeting the muscle and gut to improve metabolic health among Indian adults with (pre)diabetes: Design of the GUT-DM randomized trial

Introduction: Type 2 diabetes (T2D) is one of the most common non-communicable diseases worldwide. Current guidelines for prediabetes or T2D ((pre)diabetes) management include lifestyle modifications with or without medication. Recent evidence has indicated improvement in glycemia with gut-centric interventions (probiotics, prebiotics, or synbiotics) among (pre)diabetic patients. This study aims to explore the effect of a lifestyle intervention (exercise and dietary modification) with/without synbiotics on metabolic, physical, mental and gut health of (pre)diabetic Indian adults compared to standard of care (SOC). Methods and analysis: The calculated sample-size is 108 participants (including 25% dropouts), both sexes, 25–75 years of age, body mass index (BMI)18.5–34.9 kg/m² with either fasting, postprandial glucose or HbA1c above normal as per the American Diabetes Association (ADA, 2024). Participants will be randomized into one of 3 groups: SOC, lifestyle modification with synbiotics (LS + SYN), or lifestyle modification with placebo (LS + PLA). SOC group will follow routine practice, LS + SYN group will receive multimodal lifestyle-intervention (exercise, dietary modifications including a nutritional supplement) with synbiotic supplementation, while LS + PLA group will be enrolled for the same intervention with placebo supplementation for 12 weeks. Changes in metabolic, physical, mental and gut health will be compared between the 3 groups. Discussion: This exploratory randomized trial will assess the effectiveness of a multimodal lifestyle intervention with a gut centric approach in the management of different domains of health among (pre)diabetic adults. Since both lifestyle and gut-centric interventions individually have provided promising results, it is important to understand their combined effect to optimize management of this disease. Trial registry: Clinical trials registry-India (CTRI), registration number: CTRI/2022/08/045096.