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

NCT06503120 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2026-05-05

No results posted yet for this study

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.

Conditions

  • Fatty Liver, Nonalcoholic
  • Diet, Healthy

Interventions

BEHAVIORAL

Mediterranean-diet intervention group

Dietitian-guided Nutritionist Education Process

BEHAVIORAL

Standard care

A 10-minute talk on the epidemiology of MASLD and balanced diet, resembling routine clinical practice.

Sponsors & Collaborators

  • Taichung Veterans General Hospital

    lead OTHER

Principal Investigators

  • Ying-Cheng Lin, Bachelor · Taichung Veteran's General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-08
Primary Completion
2026-03-25
Completion
2027-03-31

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06503120 on ClinicalTrials.gov