NCT05291104

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 10, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 22, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

April 25, 2022

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2024

Completed
Last Updated

April 14, 2026

Status Verified

April 1, 2026

Enrollment Period

2.3 years

First QC Date

March 10, 2022

Last Update Submit

April 12, 2026

Conditions

Non-alcoholic Fatty Liver Disease

Keywords

Methyl nutrientsNon-alcoholic fatty liverGut-liver axisMetabolomics

Outcome Measures

Primary Outcomes (4)

  • Liver fat proportion

    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.

    One month

  • Improvement liver dysfunction progress

    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.

    One month

  • Body fat percentage

    Body fat percentage are measured by using electronic body fat meter. Body fat percentage change after intervention.

    One month

  • Plasma methyl nutrients levels

    Folate and choline concentration in plasma are detected to refer methyl nutrients levels. Methyl nutrients levels change after finishing intervention.

    One month

Secondary Outcomes (1)

  • Change microbiota

    One month

Study Arms (2)

Placebo

NO INTERVENTION

Interventions are not received any treatments.

Intervention

EXPERIMENTAL

Interventions are received folic acid or choline

Dietary Supplement: Folic acid, choline chloride

Interventions

Folic acid, choline chlorideDIETARY_SUPPLEMENT

In this study, we divide intervention group into two groups which received folic acid (FA) or choline chloride (CC) supplement. Each subgroups contain 20 subjects, including 10 men and women. According to Recommended Daily Nutrient Allowance, FA recommended intake is 400 ug / day and choline recommended intake in men and women is 450 and 390 mg / day. From phase 1 to phase 3 stage, for every 10 days, subjects are given 2-fold, 4-fold and 8-fold recommended intake dose of FA or CC. All supplement solve in 240 ml cranberry juice.

Intervention

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei Hospital, Ministry of Health and Welfare

New Taipei City, 242, Taiwan

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

Folic AcidCholine

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

PterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsEthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesTrimethyl Ammonium CompoundsQuaternary Ammonium CompoundsOnium Compounds

Study Officials

  • Yu-Shun Lin, Ph.D

    Fu Jen Catholic University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 10, 2022

First Posted

March 22, 2022

Study Start

April 25, 2022

Primary Completion

July 31, 2024

Study Completion

July 31, 2024

Last Updated

April 14, 2026

Record last verified: 2026-04

Locations

TW(1)