NCT06503120Active, not recruiting

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

A Brief, Structured Online Nutritional Education Program is Effective in the Management of Metabolic Dysfunction-Associated Steatotic Liver Disease Management: A Randomized Controlled Trial

Source: ClinicalTrials.gov · Last updated 27 May 2026

Brief summary (registry, in English)

Study Summary Title: Mediterranean Diet Intervention for Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD): A Randomized Controlled Trial (The TIMA Study) Introduction: This trial, known as the TIMA (Taiwanese Mediterranean dietary intervention for MASLD) study, evaluated the clinical impact of a culturally adapted, online nutritional program. 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.

Status (registry): Active, not recruiting
Study type: Interventional
Enrollment: 78 (actual)
First submitted: 2 Jul 2024
Start date: 8 Aug 2024
Primary completion date: 25 Mar 2026
Lead sponsor: Taichung Veterans General Hospital
Diseases: Fatty liver disease (MASLD/MASH)
NCT number: NCT06503120

What you commit to

Study type: Interventional
Participants enrolled: 78
From 8 Aug 2024 to the primary completion date, 25 Mar 2026
1 site in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

Current use of weight loss medications (e.g., Liraglutide)
Presence of active cancer or undergoing chemotherapy either at present or in the prior three years
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)

Other illness

Other liver disease (viral hepatitis, autoimmune or cholestatic liver disease, Wilson's disease, hemochromatosis, or alpha-1 anti-trypsin deficiency)
Major illness that might require hospitalization

Lab values

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

Other

Unstable body weight (variation \>5% within the preceding 3-month period)
Current use of pioglitazone
Pregnancy or lactation for women
Participation in another trial
Alcohol consumption above 30 g per day in men or 20 g per day in women

Who the study is looking for

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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
Taichung Veterans General Hospital Coordinator of this site? Confirm its status	Taichung	Taiwan	Unknown status

Related publications

A culturally adapted online Mediterranean diet intervention for metabolic dysfunction-associated steatotic liver disease (TIMA): study protocol for a randomized controlled trial.Trials · 2026 · PMID 42216178

This page is information, not medical advice. Discuss any trial with your doctor.