Status:
ACTIVE_NOT_RECRUITING
Nutritional Education Program for Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Lead Sponsor:
Taichung Veterans General Hospital
Conditions:
Fatty Liver, Nonalcoholic
Diet, Healthy
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
Detailed Description
Subject selection 1. Screening of potential subjects at the out-patient clinic Consecutive patients attending the hepatology of the Taichung Veterans General Hospital will be screened. Patients with ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 8 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2026
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT06503120
Start Date
August 8 2024
End Date
December 31 2026
Last Update
December 30 2025
Active Locations (1)
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1
Taichung Veterans General Hospital
Taichung, Taichung, Taiwan, 407219