Nutritional Education Program for Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
NCT Number: NCT06503120
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Fatty Liver, Nonalcoholic|Diet, Healthy
Interventions: BEHAVIORAL: Mediterranean-diet intervention group|BEHAVIORAL: Standard care
Sponsor: Taichung Veterans General Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 78
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-07
Completion Date: 2026-12-31

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.

Primary Outcome Measures: intrahepatic fat, Change in intrahepatic fat by MRI at the end of week 12, Week 0 and week 12
Secondary Outcome Measures: Stool microbiome, Change in the alpha-diversity and beta-diversity of stool microbiome, Week 0 and week 12; At the sixth and twelfth months after completion of the trial|Alanine Aminotransferase, Alanine Aminotransferase changes, Week 0 and week 12; At the sixth and twelfth months after completion of the trial|Level of HbA1c, HbA1c, Week 0 and week 12; At the sixth and twelfth months after completion of the trial|HOMA-IR, insulin resistance (homeostatic model assessment of insulin resistance; HOMA-IR), Week 0 and week 12; At the sixth and twelfth months after completion of the trial|hepatic fibrosis (elastography), Changes in elastography measurement by fibroscan. The normal range for the elastography is between 2 to 7 kPa., Week 0 and week 12; At the sixth and twelfth months after completion of the trial|Serum metabolites, Changes in the amount of secondary bile salts. Tiny amounts of bile salts, up to 1 or 2 μg per ml, are present normally in the blood., Week 0 and week 12; At the sixth and twelfth months after completion of the trial|Quality of life (QoL), World Health Organization Quality-of-Life Scale, is a 26-item instrument consisting of four domains. The scores are then transformed linearly to a 0-100-scale., Week 0 and week 12; At the sixth and twelfth months after completion of the trial|Compliance, Taiwanese version of the Mediterranean Diet Adherence Screener, Week 0 and week 12; At the sixth and twelfth months after completion of the trial|intrahepatic fat, Change in intrahepatic fat at the end of 1 year, twelfth months after completion of the trial