Dietary Allowance of Methyl Donor Nutrients to Minimize Risks of Non-alcoholic Fatty Liver Progression
- Conditions
- Non-alcoholic Fatty Liver Disease
- Interventions
- Dietary Supplement: Folic acid, choline chloride
- Registration Number
- NCT05291104
- Lead Sponsor
- Fu Jen Catholic University Hospital
- Brief Summary
Investigate the methyl donors requirement of NAFLD patients to correct the malnutrition, lipid-toxicity, microbiota dysfunction, and metabolomics biomarkers.
- Detailed Description
Folate/choline/betaine, service as a methyl-donor nutrients, are essential nutrients involving in hepatic one-carbon and bioenergetic metabolism. Methyl-donor nutrients deficiency cause liver and muscle dysfunction as result of non-alcoholic fatty liver diseases (NAFLD) and its progressive lesions of steatohepatitis (NASH), fibrinogen cirrhosis and hepatoma. As methyl-donor nutrients intakes in Taiwanese population are highly insufficient, the dietary requirement of methyl-donor nutrients upon genetic, epigenetic and microbiota interaction to prevent or/and co-therapy of NAFLD progression is currently not known. In this study, we investigate whether intervention of methyl-donor nutrients improve or retard NAFLD progress. NAFLD patients are randomly divided into three groups and received placebo, folic acid, or choline, respectively. From first day to ten day, interventions are given double recommended daily intake dose of folic acid or double adequate Intakes dose of choline, then continuing with four times, and eight times dose for every 10 days. All supplements solve in cranberry juice. At the end of every ten days intervention prior, interventions are measurement of weight and body fat, and collection of blood and feces. The primary outcome measures are described to decreased body weight or body fat, improvement of liver function and fatty liver, and increasing methyl-donor nutrients levels.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 60
- NAFLD/NASH patients
- Folate levels in plasma < 6 ng/mL or choline levels in plasma < 5 micromol per liter
- Folate intake < estimated average requirement or choline intake < 50% adequate Intakes
- Homocysteine levels in plasma > 9 micromol per liter
- Asymptomatic carrier of hepatitis B and C
- Liver disease except NAFLD
- Taking drugs that causes fatty liver
- Inflammation about stomach or intestines
- Pregnancy
- Cancer except liver cancer
- Heart disease, vascular disease, or psychosis
- Intake alcohol over 100 g or unaccessible intake alcohol
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Folic acid, choline chloride Interventions are received folic acid or choline
- Primary Outcome Measures
Name Time Method Plasma methyl nutrients levels One month Folate and choline concentration in plasma are detected to refer methyl nutrients levels. Methyl nutrients levels change after finishing intervention.
Body fat percentage One month Body fat percentage are measured by using electronic body fat meter. Body fat percentage change after intervention.
Improvement liver dysfunction progress One month To estimate liver dysfunction, we detect biochemical markers in plasma, including alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, and glutamyl transpeptidase. After finishing intervention, we assume improving liver function.
Liver fat proportion One month To estimate hepatic fat content, interventions are detected fat content in liver by using MRI or abdominal ultrasound. We assume changing liver fat proportion after finishing intervention.
- Secondary Outcome Measures
Name Time Method Change microbiota One month After intervention change microbiota to improve NAFLD
Trial Locations
- Locations (1)
Taipei Hospital, Ministry of Health and Welfare
🇨🇳New Taipei City, Taiwan