A Feasibility Trial of OCM Supplements for the Treatment of NAFLD

Early Phase 1

Completed

• Conditions: NAFLD
• Interventions: Dietary Supplement: homocysteine (Hcy) lowering supplements

• Registration Number: NCT05720702
• Lead Sponsor: Duke University

Brief Summary

The purpose of the study is to assess the feasibility of a trial to test the effects of homocysteine (Hcy) lowering supplements in patients with NAFLD.

NAFLD patients 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 to complete activities such as physical exam, fibroscan, blood draws, and questionnaires.

Detailed Description

The purpose of the study is to assess the feasibility of a trial to test the effects of homocysteine (Hcy) lowering supplements in patients with NAFLD.

NAFLD patients 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

Study Timeline

• Study First Submitted: 2023-01-31
• Study First Submitted QC: 2023-01-31
• Study First Posted: 2023-02-09
• Study Start: 2023-06-30
• Primary Completion: 2024-08-23
• Study Completion: 2024-08-23
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-26
• Last Update Posted: 2024-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
NAFLD Group	homocysteine (Hcy) lowering supplements	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

Primary Outcome Measures

Name	Time	Method
FibroScan-aspartate aminotransferase (FAST) score	12 weeks	To minimize interindividual variability of fibroscan measurements, all of the fibroscan will be performed by a single, experienced operator using the same probe (M vs. XL) and technique for the paired measurements. The FibroScan-aspartate aminotransferase (FAST) score is a simple algorithm that can diagnose NASH using an elevated (≥ 4) NAFLD activity score (NAS) and significant fibrosis score (≥ 2).

Secondary Outcome Measures

Name	Time	Method
Feasibility as measured by percentage of completion of enrollment	4 months	The trial design will be considered feasible if at least 13 NAFLD patients (≥80%) are enrolled over the 4-month period
Assess safety of the trial.	12 weeks	Based on reported adverse reactions.

Trial Locations

Locations (1)

Duke University; 🇺🇸 Durham, North Carolina, United States