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.

The trial targets Indian adults with (pre)diabetes defined by fasting glucose, postprandial glucose, or HbA1c above normal thresholds per ADA 2024 criteria.

• Eligible participants must have fasting, postprandial glucose, or HbA1c above normal as per the American Diabetes Association (ADA, 2024)
• Participants are aged 25–75 years
• BMI eligibility range is 18.5–34.9 kg/m²
• Both sexes are included

The calculated sample size for the trial is 108 participants, accounting for an anticipated 25% dropout rate.

• Total sample size is 108 participants including 25% dropouts
• Participants are randomized into one of 3 groups: SOC, LS + SYN, or LS + PLA
• The trial is registered with Clinical Trials Registry-India (CTRI), registration number: CTRI/2022/08/045096

The trial uses a three-arm randomized design comparing standard of care, lifestyle modification with synbiotics, and lifestyle modification with placebo.

• SOC group follows routine clinical practice
• LS + SYN group receives multimodal lifestyle intervention (exercise, dietary modifications including a nutritional supplement) with synbiotic supplementation
• LS + PLA group receives the same multimodal lifestyle intervention with placebo supplementation
• The intervention duration is 12 weeks

The trial measures outcomes across multiple health domains including metabolic, physical, mental, and gut health.

• Changes in metabolic, physical, mental, and gut health will be compared between the 3 groups
• The trial is described as an 'exploratory randomized trial'
• The study aims to assess the effectiveness of a multimodal lifestyle intervention with a gut-centric approach

The study rationale is based on existing evidence that gut-centric interventions (probiotics, prebiotics, or synbiotics) improve glycemia among (pre)diabetic patients.

• Recent evidence has indicated improvement in glycemia with gut-centric interventions among (pre)diabetic patients
• Both lifestyle and gut-centric interventions individually have provided promising results
• The authors state 'it is important to understand their combined effect to optimize management of this disease'
• Current guidelines for (pre)diabetes management include lifestyle modifications with or without medication