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Dietary Allowance of Methyl Donor Nutrients to Minimize Risks of Non-alcoholic Fatty Liver Progression

Non-alcoholic Fatty Liver Disease Clinical Trial

Official title:
Dietary Allowance of Methyl Donor Nutrients to Minimize Risks of Non-alcoholic Fatty Liver Progression: Novel Diagnostic and Therapeutic Markers in Metabolomics of Gut Microbiome/Host Methyl Nutrition and the Working Mechanisms

Clinical Trial Summary

Investigate the methyl donors requirement of NAFLD patients to correct the malnutrition, lipid-toxicity, microbiota dysfunction, and metabolomics biomarkers.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05291104
Study type Interventional
Source Fu Jen Catholic University Hospital
Contact
Status Enrolling by invitation
Phase N/A
Start date April 1, 2022
Completion date July 31, 2024
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