Active — Not RecruitingNot Applicable

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

Taiwan78 participantsStarted 2024-08-08

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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 * Participat…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

intrahepatic fat

Timeframe: Week 0 and week 12

Trial details

NCT IDNCT06503120

SponsorTaichung Veterans General Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-03-25

View on ClinicalTrials.gov More Fatty Liver, Nonalcoholic trials