Abstract
BACKGROUND: Lifestyle modifications, including nutritional therapy and physical activity, are recommended as a first-line treatment for non-alcoholic fatty liver disease (NAFLD). However, both the best dietary approach and the optimal exercise pattern remain controversial. We will assess the efficacy of structured exercise and oats supplementation in NAFLD patients. METHODS/DESIGN: Participants aged 18-65 years with intrahepatic lipid content ≥5% according to quantitative computed tomography (QCT) (N = 180) will be included in this randomized controlled 24-week structured exercise and dietary intervention study. Eligible participants will be randomly assigned (1:1:1:1) to the structured exercise group (aerobic exercise and resistance training), diet intervention group (80 g oats/daily supplementation), combined group (structured exercise + diet intervention) or control group. All participants will receive routine lifestyle education based on their daily caloric intake. The primary outcome was the change in the intrahepatic lipid content in the four groups. Body composition, muscle strength, and 72-hour dietary records will be assessed, and blood, urine and faeces tissue samples at baseline and at 12 and 24 weeks will be collected. Data will be analysed using t tests or Wilcoxon rank sum tests to compare the changes in the outcome measures among the different groups. DISCUSSION: There are limited data on the efficiency of structured exercise and oat supplementation for NAFLD treatment. The findings of this study will provide evidence-based data to health providers on lifestyle interventions aimed at alleviating the current NAFLD epidemic. TRIAL REGISTRATION: The study was registered with the Chinese Clinical Trial Registry (ChiCTR2100048042) on June 28, 2021.