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

F

Fu Jen Catholic University Hospital

Status

Invitation-only

Conditions

Non-alcoholic Fatty Liver Disease

Treatments

Dietary Supplement: Folic acid, choline chloride

Study type

Interventional

Funder types

Other

Identifiers

NCT05291104
C108076

Details and patient eligibility

About

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

Full 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.

Enrollment

60 estimated patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

60 participants in 2 patient groups

Placebo
No Intervention group
Description:
Interventions are not received any treatments.
Intervention
Experimental group
Description:
Interventions are received folic acid or choline
Treatment:
Dietary Supplement: Folic acid, choline chloride

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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