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

Launched by TAICHUNG VETERANS GENERAL HOSPITAL · Jul 9, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a Mediterranean diet on patients with Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD), which is a condition where fat builds up in the liver without alcohol being the cause. The main goal is to see if following this specific diet can reduce fat in the liver more effectively than standard dietary advice. Participants will be randomly assigned to either follow the Mediterranean diet or receive standard care for 12 weeks. The study will also look at how this diet impacts liver function, blood sugar levels, and overall quality of life.

To be eligible for the trial, participants should be between 18 and 70 years old, willing to change their diet for at least three months, and have a certain level of fat in their liver as confirmed by a medical test. They should not have other serious liver diseases or be on specific medications that could interfere with the study. Those who join can expect to receive guidance on the Mediterranean diet, which emphasizes healthy foods like fruits, vegetables, nuts, and olive oil, and will complete surveys to track their progress. This trial is not yet recruiting participants, but it aims to provide valuable insights into how diet can help manage liver health.

Gender

ALL

Eligibility criteria

• 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
• • 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