Impact of Supervised and Structured Diet and Exercise in Management of Patients with Metabolic Dysfunction Associated Steatohepatitis– A Randomized Controlled Trial

Abstract

Background: Metabolic Dysfunction Associated Steatohepatitis (MASH) represents the progressive, inflammatory form of metabolic dysfunction associated fatty liver disease (MAFLD), which has emerged as a global health concern. Given the lack of approved pharmacological treatments for MASH, structured lifestyle interventions involving supervised diet and exercise have gained attention.

Objective: To evaluate the impact of a supervised and structured dietary and physical activity intervention on liver health, metabolic parameters, and anthropometric indices in newly diagnosed MASH patients.

Methods: A randomized controlled trial was conducted among 188 first-time diagnosed MASH patients at KLE’s Dr. Prabhakar Kore Hospital and Medical Research Centre, Belagavi. Participants were randomly assigned to either a study group (supervised structured diet and exercise regimen) or a control group (standard care). Anthropometry, liver function tests, lipid profile, and FibroScan parameters were recorded at baseline and 24 weeks. The intervention included a calorie-restricted Mediterranean diet, aerobic exercise (30–45 minutes/day for 5 days/week), and weekly telephonic follow-up.

Results: Participants in the intervention group demonstrated statistically significant improvements across all measured parameters over 24 weeks. Notable reductions were observed in weight (↓11.41 kg), BMI (↓3.73 kg/m²), waist circumference (↓3.69 cm), AST (↓20.27 U/L), ALT (↓32.35 U/L), triglycerides (↓99 mg/dL), CAP score (↓61.89 dB/m), LSM (↓4.05 kPa), FIB-4 (↓0.22), and APRI (↓0.12) (p < 0.05 for all). Post-intervention, 86.1% of participants in the intervention group attained “good” health practice scores compared to 15% in the control group.

Conclusion: Supervised and structured dietary and exercise interventions significantly improved clinical and biochemical markers in MASH patients. Incorporating such lifestyle modifications into routine care may mitigate disease progression and improve long-term outcomes.