Abstract
BACKGROUND/AIMS: Insulin resistance is a key pathogenic mechanism in metabolic dysfunction-associated steatohepatitis (MASLD). Time-restricted eating (TRE) has the potential to restore insulin sensitivity in patients with metabolic disorders. We investigated the effects of time-restricted eating on insulin resistance, metabolic profile, and steatosis in individuals with MASLD. METHODS: The study was conducted at King George's Medical College, Lucknow, and Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, from November 2024 to May 2025, with participants recruited from the medicine and hepatology outpatient departments. Adults aged 18-60 years with MASLD were screened for eligibility, excluding those with diabetes, advanced fibrosis, chronic comorbid illnesses, pregnancy, or those already undergoing treatment for MASLD. Participants were randomized to either a hypocaloric diet with time-restricted eating (TRE + HCD) or hypocaloric diet alone (HCD). The primary objective was to measure the mean changes in homeostatic model assessment of insulin resistance (HOMA-IR) at 12 weeks, while the secondary objective was to compare the proportion of participants with at least one-grade improvement in hepatic steatosis. RESULTS: A total of 84 participants, 42 in each arm were enrolled. Baseline characteristics were comparable between groups. In the intention-to-treat analysis, the mean reduction in HOMA-IR was 2.6 ± 1.9 in the TRE + HCD group and 1.55 + 1.2 in the HCD group (P = 0.024). Overall, 66.7% of participants in the TRE + HCD arm and 52.4% in the HCD arm achieved a 1-grade improvement in steatosis (P = 0.26). CONCLUSION: Time-restricted eating over 12 weeks led to greater improvement in insulin resistance compared to hypocaloric diet alone in MASLD subjects.