A Brief, Structured Online Nutritional Education Program is Effective in the Management of Metabolic Dysfunction-Associated Steatotic Liver Disease Management: 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.
• Willing to change diet for at least three months (accepting reduced sugar, less processed foods, reduced red meat, and following a Mediterranean diet with olive oil, high-fiber foods, vegetables, fruits, nuts, and legumes)
• Intrahepatic triglyceride content (IHTG) of 5%
• Age 18 to 70 years
• Fulfill the diagnosis of Metabolic Dysfunction-Associated Steatotic Liver Disease
• Baseline Mediterranean Diet Adherence Screener (T-MEDAS) score equal to or less than 5
• Participants must not have initiated any new probiotic treatment in the past three months or must have been on a stable probiotic regimen for at least three months, which they are willing to continue for the duration of the study