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Dietary Supplement

Hcy Lowering Supplements for Non-alcoholic Fatty Liver Disease

N/A
Recruiting
Led By Ayako Suzuki
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 months
Awards & highlights
No Placebo-Only Group

Summary

This trial will assess the effects of Hcy-lowering supplements on NAFLD patients. Supplements taken daily for 12 weeks, with physical exams, blood draws, & questionnaires.

Who is the study for?
This trial is for adults over 18 with Non-alcoholic Fatty Liver Disease (NAFLD), who have increased liver fat confirmed by ultrasound or CT, a high CAP score, insulin resistance or metabolic syndrome, and chronic elevated liver enzymes. Participants must have been on stable NAFLD treatments for at least 6 months.
What is being tested?
The study tests if homocysteine-lowering supplements (Vitamin B12, Folate, Vitamin B6, Betaine) taken daily can benefit those with NAFLD. Over about 3 months, participants will visit the clinic twice and have two phone calls to check their health status through exams and questionnaires.
What are the potential side effects?
Potential side effects of the supplements may include allergic reactions, mild digestive upset like nausea or diarrhea, headache, feeling of being fullness or loss of appetite. However specific side effects related to this trial are not detailed.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
FibroScan-aspartate aminotransferase (FAST) score
Secondary study objectives
Assess safety of the trial.
Feasibility as measured by percentage of completion of enrollment

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: NAFLD GroupExperimental Treatment1 Intervention
The NAFLD group will be asked to take Hcy lowering supplements (Vitamin B12, Folate, Vitamin B6, and Betaine) daily for 12 weeks. Over the course of approximately 12 to 13 weeks, participants will complete two in person visits and two phone visits. During the in person visits NAFLD participants will complete the following activities: Review medical history; Physical examination; Vital signs (blood pressure, heart rate, respiratory rate, body temperature); Measure height, weight, body mass index, and waist circumference; Grip test; Fasting blood tests; Pregnancy test (if applicable); Fibroscan with CAP score; QOL questionnaire

Find a Location

Who is running the clinical trial?

Duke UniversityLead Sponsor
2,454 Previous Clinical Trials
2,971,591 Total Patients Enrolled
8 Trials studying Non-alcoholic Fatty Liver Disease
2,134 Patients Enrolled for Non-alcoholic Fatty Liver Disease
Ayako SuzukiPrincipal InvestigatorDuke University
1 Previous Clinical Trials
70 Total Patients Enrolled
1 Trials studying Non-alcoholic Fatty Liver Disease
70 Patients Enrolled for Non-alcoholic Fatty Liver Disease

Media Library

Non-alcoholic Fatty Liver Disease Research Study Groups: NAFLD Group
Homocysteine (Hcy) lowering supplements (Dietary Supplement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05720702 — N/A
~9 spots leftby Nov 2025
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