Clinical trial NCT05291104: Dietary Allowance of Methyl Donor Nutrients to Minimize Risks of Non-alcoholic Fatty Liver Progression
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Non-alcoholic Fatty Liver Disease
Keywords: Methyl nutrients
Non-alcoholic fatty liver
Gut-liver axis
Metabolomics
Lead sponsor: Fu Jen Catholic University Hospital
Sponsor class: OTHER
First posted: 2022-03-22
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Liver fat proportion
timeFrame: One month
measure: Improvement liver dysfunction progress
timeFrame: One month
measure: Body fat percentage
timeFrame: One month
measure: Plasma methyl nutrients levels
timeFrame: One month
Secondary outcomes:
measure: Change microbiota
timeFrame: One month
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: Taipei Hospital, Ministry of Health and Welfare
Study officials:
affiliation: Fu Jen Catholic University
name: Yu-Shun Lin, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: