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 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 range18 Years

SexALL

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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…

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