ArticleTrials2026
A culturally adapted online Mediterranean diet intervention for metabolic dysfunction-associated steatotic liver disease (TIMA): study protocol for a randomized controlled trial.
Article in Trials, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06503120 (A Brief, Structured Online Nutritional Education Program is Effective in the Management of Metabolic Dysfunction-Associated Steatotic Liver Disease Management), which is not on this map. Not yet cited in PubMed.
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A Brief, Structured Online Nutritional Education Program is Effective in the Management of Metabolic Dysfunction-Associated Steatotic Liver Disease Management: A Randomized Controlled Trial
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22 authors.
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Abstract
backgroundThe Mediterranean diet (MedDiet) is widely recognized for its beneficial effects on hepatic steatosis. However, optimal strategies to support dietary adherence among patients with metabolic dysfunction-associated steatotic liver disease (MASLD), particularly in non-Mediterranean regions where the MedDiet is not habitual, remain underexplored.
objectiveTo evaluate the effectiveness of a culturally adapted MedDiet for MASLD through the implementation of real-time video counseling combined with behavior change techniques (BCTs).
methodsThis is a 12-week, single-center, two-arm, parallel-group randomized controlled trial registered at ClinicalTrials.gov (identifier: NCT06503120). Adults who fulfill the clinical diagnosis of MASLD and have ≥ 5% hepatic fat content on MRI-PDFF will be randomly assigned to receive either an isocaloric culturally adapted MedDiet intervention or standard care. The intervention comprises two components. First, participants will receive four structured real-time video counseling sessions (15-20 min each) at weeks 0, 3, 6, and 9. These sessions will be delivered by a registered dietitian via an online platform, guided by each participant's 3-day photographic food diary and a Taiwanese version Mediterranean Diet Adherence Screener scores to provide personalized dietary advice. Second, participants will receive weekly text messages underpinned by BCTs to address individual dietary gaps and reinforce adherence. The primary outcome is the relative change in intrahepatic fat content, assessed by MRI-PDFF at week 12. Secondary outcomes include the changes in liver enzymes, lipid profile, liver stiffness, serum metabolites, gut microbiota composition, dietary adherence, quality of life, and anthropometric measures. DISCUSSION: This is the first randomized controlled trial to evaluate a fully remote, dietitian-led culturally adapted MedDiet intervention using real-time video counseling and text-based BCTs in patients with MASLD. This approach may support scalable, patient-centered dietary strategies for improving liver and metabolic health in this population.
trial registrationClinicalTrials.gov NCT06503120. Registered on July 9, 2024.
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