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

NCT06503120 | Active Not Recruiting

• 1 other identifier: CG23418A
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

MASLD, Mediterranean diet

Outcome Measures

Primary Outcomes (1)

• intrahepatic fat

  Change in intrahepatic fat by MRI at the end of week 12

  Week 0 and week 12

Secondary Outcomes (9)

• Stool microbiome

  Week 0 and week 12; At the sixth and twelfth months after completion of the trial

• Alanine Aminotransferase

  Week 0 and week 12; At the sixth and twelfth months after completion of the trial

• Level of HbA1c

  Week 0 and week 12; At the sixth and twelfth months after completion of the trial

• HOMA-IR

  Week 0 and week 12; At the sixth and twelfth months after completion of the trial

• hepatic fibrosis (elastography)

  Week 0 and week 12; At the sixth and twelfth months after completion of the trial

Study Arms (2)

Mediterranean-diet intervention group

EXPERIMENTAL

Dietitian-guided Nutritionist Education Process: 1. Conduct online educational sessions at Weeks 0, 3, 6, and 9, lasting 10 to 15 minutes each. 2. The ultimate goal is to increase the MEDAS score by more than five points within 12 weeks. 3. After the initial education session, provide participants with a common Q and A sheet, online, based on the dietary advice given. Investigators also provide education materials, a food-group list specifying preferred choices and approximate numbers and size of servings to consume per day.

Behavioral: Mediterranean-diet intervention group

Standard care group

ACTIVE COMPARATOR

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

Behavioral: Standard care

Interventions

Standard care BEHAVIORAL

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

Standard care group

Mediterranean-diet intervention group BEHAVIORAL

Dietitian-guided Nutritionist Education Process

Mediterranean-diet intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Other liver disease (viral hepatitis, autoimmune or cholestatic liver disease, Wilson's disease, hemochromatosis, or alpha-1 anti-trypsin deficiency)
• Unstable body weight (variation \>5% within the preceding 3-month period)
• Current use of weight loss medications (e.g., Liraglutide)
• Current use of pioglitazone
• Unstable diabetes (HbA1c \>8.5%)
• Decompensated cirrhosis (international normalized ratio \>1.3, platelets \<100 × 109/mm, bilirubin \>20 mmol/L, albumin \<35 g/L, ascites, or hepatic encephalopathy)
• A serum creatinine level ≥ 2mg/dL
• Presence of active cancer or undergoing chemotherapy either at present or in the prior three years
• Major illness that might require hospitalization
• Pregnancy or lactation for women
• Participation in another trial
• Chronic treatment with warfarin (given its interaction with vitamin K)
• Being implanted with a pacemaker or platinum implant (due to inability to undergo magnetic resonance imaging included in the study design)
• Alcohol consumption above 30 g per week in men or 20 g per week in women

Sponsors & Collaborators

• Taichung Veterans General Hospital: lead

Study Sites (1)

Taichung Veterans General Hospital

Taichung, Taichung, 407219, Taiwan

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Ying-Cheng Lin, Bachelor

  Taichung Veteran's General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Radiologists who evaluate the magnetic resonance images, physicians performing transient elastography using Fibroscan, and statisticians analysing the final results will be blinded to the treatment assignments.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician, Division of Gastroenterology, Principal Investigator, Clinical Professor

Model Details: A 12-week, prospective, two parallel-group, randomized controlled trial. One group is Mediterranean-diet intervention group; Another group is standard care

Study Record Dates

• First Submitted: July 2, 2024
• First Posted: July 16, 2024
• Study Start: August 8, 2024
• Primary Completion: March 25, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: Protocol and SAP will be published first when investigators start the trial. CSR and analytic code will be shared starting 6 months after publication
• Access Criteria: Data will be available to qualified researchers affiliated with academic or research institutions for the purpose of conducting scientifically valid analyses. Requests for access must include a detailed research proposal outlining the objectives, methodology, and potential impact of the analysis. Access will be granted through a secure data-sharing platform, ensuring the protection of participant confidentiality. Requests will be reviewed by an independent data access committee, which will evaluate proposals based on scientific merit, ethical considerations, and the potential to contribute to the advancement of knowledge in the field. Researchers must also agree to use the data solely for the approved analyses and comply with data protection regulations.

Locations

TW (1)