Effect of an early time restricted eating Mediterranean diet compared to naltrexone/bupropion on liver fibrosis in people with cardiometabolic risk factors in a hospital outpatient clinic: study protocol for a randomised controlled trial (MEDFAST trial)

作者：Carmen A. W. Dietvorst, Laura A M Konings, Alina Saidi, Tessa Noordermeer, Martien van Wenum, Robin P. Peeters, Kirsten A. Berk, Manuel Castro Cabezas · 发表于：BMJ Open · 年份：2026 · DOI：10.1136/bmjopen-2025-113058 · 研究领域：Liver Disease Diagnosis and Treatment、Dietary Effects on Health、Nutritional Studies and Diet

INTRODUCTION: Metabolic dysfunction-associated steatotic liver disease (MASLD) is a progressive condition that may lead to liver cirrhosis and hepatocellular carcinoma. It is strongly associated with cardiometabolic diseases such as type 2 diabetes (T2D) and obesity. Weight loss is a key therapeutic strategy to treat MASLD. In recent years, there has been increasing attention to weight-reducing medication, but promising dietary interventions-such as early time restricted eating (eTRE)-have also been developed. Whether these dietary interventions are a good alternative to weight-reducing medication remains unclear, as direct comparative studies are still lacking. Therefore, this study will compare the effects of an early time restricted eating Mediterranean diet (eTRE-MD) intervention with naltrexone/bupropion (N/B) treatment on liver fibrosis, measured as liver stiffness (LSM) by transient elastography, in individuals with cardiometabolic risk factors. METHODS AND ANALYSIS: We will conduct a randomised controlled trial with a planned sample size of 70 overweight (Body mass index, BMI >27 kg/m2) adults aged 18-75 years with T2D, hypertension, dyslipidaemia or obesity and moderate to severe liver fibrosis, measured as LSM (>7.0 kPa and <13.6 kPa). The diet group will receive eTRE-MD, with a 10-hour eating time restriction (8AM-6PM). The medication group will receive 32 mg/360 mg of N/B (after a dose increase period following Summary of Product Characteristics). The main study e...