Clinical Research Directory

Nutritional Education Program for Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)

Sponsor: Taichung Veterans General Hospital

Summary

Study Summary Title: Mediterranean Diet Intervention for Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD): A Randomized Controlled Trial Aims: * Primary Aim: Assess the impact of an iso-calorie Mediterranean diet compared to standard care on intrahepatic fat in MASLD patients. * Secondary Aims: Evaluate the effects on liver function tests, lipid profiles, HbA1c and insulin resistance (homeostatic model assessment of insulin resistance; HOMA-IR), noninvasive assessment of hepatic fibrosis with transient elastography by Fibroscan, Framingham Risk Score (FRS), serum metabolites, quality of life (QoL), compliance and stool microbiome. Study Design: * Type: 12-week, prospective, two parallel-group, randomized controlled trial. * Participants: MASLD patients with \>5% hepatic steatosis diagnosed by MRI-PDFF, randomized into two groups: Mediterranean diet intervention and standard care. Randomization: * Method: Computer-generated random numbers, 1:1 allocation. * Blinding: Radiologists and statisticians blinded to treatment assignment. Intervention: * Mediterranean Diet Group: Specific dietary guidelines provided. * Standard Care Group: Simple lifestyle advice. Compliance: • Monitored through standardized questionnaires and T-MEDAS at each visit. Assessments: Reduction of hepatic triglyceride content by MRI-PDFF at baseline and week 12. Conclusion: This trial aims to determine the effectiveness of a Mediterranean diet in reducing intrahepatic fat and improving related metabolic and microbiome parameters in MASLD patients compared to standard care.

Official title: A Brief, Structured Online Nutritional Education Program is Effective in the Management of Metabolic Dysfunction-Associated Steatotic Liver Disease Management: A Randomized Controlled Trial

Key Details

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Interventions

Locations (1)