Efficacy and safety of time-restricted eating in metabolic dysfunction-associated steatotic liver disease

Abstract

Background & Aims: Time-restricted eating (TRE) may improve weight loss, insulin resistance, and body composition, which are key factors in the pathophysiology of metabolic dysfunction-associated steatotic liver disease (MASLD). However, evidence on the efficacy of TRE in patients with MASLD is limited. This study aimed to evaluate the potential benefits of TRE in patients with overweight or obesity and MASLD. Methods: In this 16-week randomized controlled trial, patients with overweight or obesity and MASLD were randomized into three groups in a 1:1:1 ratio: standard of care (SOC), calorie restriction (CR), and TRE. The primary endpoint was an improvement in hepatic steatosis, measured using MRI-proton density fat fraction. Changes in liver fibrosis, body composition, lipid profiles, glucose homeostasis, and sleep quality were also analyzed. Results: Among the 337 participants randomized, 333 were included in the full analysis set (113 in SOC, 110 in CR, and 110 in TRE). After the 16-week intervention, hepatic steatosis significantly decreased in the TRE group (-25.8%) compared to the SOC group (0.7%, p <0.001), with no significant difference between TRE and CR (-24.7%, p >0.999). The TRE group also showed greater reductions in body weight, waist circumference, and body fat mass compared to the SOC group, while changes were comparable between TRE and CR. Liver stiffness, glucose homeostasis, and sleep quality were similar between the TRE and CR groups. No serious adverse events were reported. Conclusions: TRE effectively reduces hepatic steatosis in MASLD, with comparable benefits on weight loss, body composition, and metabolic parameters as CR. This approach may serve as a practical dietary strategy for MASLD management. ClinicalTrals.gov: NCT05579158. Impact and implications: The efficacy of time-restricted eating in managing metabolic dysfunction-associated steatotic liver disease (MASLD) remains uncertain despite its potential metabolic benefits. This 16-week randomized controlled trial compared the effects of time-restricted eating, calorie restriction, and standard of care on hepatic steatosis and metabolic outcomes in patients with MASLD. Time-restricted eating effectively reduces hepatic steatosis in MASLD, with comparable benefits on weight loss, body composition, and metabolic parameters as calorie restriction. Time-restricted eating may serve as a practical dietary strategy for MASLD management, warranting further long-term investigations.