Time Restricted Eating versus Standard Care in Metabolic Dysfunction-associated Steatotic Liver Disease: A Randomized Controlled Trial of Fibrosis Surrogates and Cardiometabolic Risk Over 12 Weeks

Background and Aims: Metabolic dysfunction-associated steatotic liver disease (MASLD) is common and strongly linked to cardiometabolic morbidity and mortality. Lifestyle modification is first-line therapy, but adherence to sustained calorie restriction is difficult in routine care. Time-restricted eating (TRE) is a simple meal-timing strategy that may improve cardiometabolic risk through circadian alignment. We tested whether a 12-week 16:8 TRE protocol improves noninvasive fibrosis surrogate scores compared with guideline-based standard dietary care when participant-specific calorie prescriptions and macronutrient targets are matched between groups. Materials and Methods: Single-center, open-label, parallel-group randomized controlled trial in adults (18–65 years) with MASLD. Participants were allocated 1:1 to TRE (all prescribed calories within a consistent 8-hour window daily) or standard care (same prescribed calories/macronutrients distributed across the day) for 12 weeks. Primary outcomes were change in FIB-4 and NAFLD Fibrosis Score (NFS) from baseline to week 12. The secondary outcomes included weight, body mass index (BMI), waist circumference, blood pressure (BP), fasting glucose, HbA1c, lipids, alanine aminotransferase/aspartate aminotransferase (ALT/AST), C-reactive protein (CRP), platelets, albumin, and APRI. FIB-4, NFS, and APRI were calculated using published formulae. Analyses used a modified intention-to-treat approach (complete cases) with baseline-adjusted sensitivity analyses where relevant. Reporting followed CONSORT. Results: Of 123 screened, 100 were randomized; 90 completed follow-up (TRE n = 44; standard care n = 46). TRE did not outperform standard care for FIB-4 (week-12 mean 1.15 vs. 1.13; between-group P = 0.79) or NFS (−2.26 vs. −2.12; P = 0.80). TRE achieved greater reductions in body weight (−4.04 vs. −1.63 kg; P = 0.025), BMI (−1.33 vs. −0.55 kg/m 2 ; P = 0.030), systolic BP (−8.22 vs. −3.04 mmHg; P = 0.014), fasting glucose ( P = 0.015), and triglycerides (−11.30 vs. −1.93 mg/dL; P = 0.040). ALT/AST and CRP improved similarly in both groups. No serious adverse events were reported. Conclusions: Over 12 weeks, 16:8 TRE did not improve fibrosis surrogate scores beyond guideline-based standard dietary care when calorie/macronutrient prescriptions were matched, but it produced clinically relevant improvements in weight, BMI, systolic BP, fasting glucose, and triglycerides. Longer duration and sustained larger weight loss may be required to meaningfully influence fibrosis risk.