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A Feasibility Trial of OCM Supplements for the Treatment of NAFLD

Primary Purpose

NAFLD

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
homocysteine (Hcy) lowering supplements
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for NAFLD

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

We will enroll NAFLD patients, blocked by age 50 years (≤ 50; > 50) and sex (M; F, four patients/subjects in each block). Inclusion Criteria for NAFLD Group: Increased hepatic fat accumulation diagnosed by either abdominal ultrasound or CT AND elevated CAP score of 280 dB/m or higher HOMA-IR ≥ 2 or the diagnosis of metabolic syndrome Chronic elevation of transaminases: ALT elevation (more than 2 times during the past 12 months, defined by 19 U/L for women and 30 U/L for men 31) Stable use of any potential anti-NASH therapy (i.e., vitamin E, pioglitazone, glucagon like peptide 1 agonist, etc.) for 6 months prior to screening. Aged 18+ years Able to provide legal consent Exclusion Criteria for NAFLD Group: Any contraindication to the study supplements Inability to obtain valid fibroscan measures at the screening Pregnancy or lactation Clinical diagnosis of cirrhosis or other chronic liver diseases Recent use of steatogenic medications Excess alcohol use (>21/ >14 drinks weekly in men/women) Chronic kidney disease Supplement use within 30 days, containing any of the study supplements Total parenteral nutrition Any clinical conditions associated with malabsorption Any active diagnosis of malignancy Use of immunosuppression

Sites / Locations

  • Duke UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

NAFLD Group

Arm Description

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

Outcomes

Primary Outcome Measures

FibroScan-aspartate aminotransferase (FAST) score
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

Feasibility as measured by percentage of completion of enrollment
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.
Based on reported adverse reactions.

Full Information

First Posted
January 31, 2023
Last Updated
July 17, 2023
Sponsor
Duke University
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1. Study Identification

Unique Protocol Identification Number
NCT05720702
Brief Title
A Feasibility Trial of OCM Supplements for the Treatment of NAFLD
Official Title
A Feasibility Trial of One-carbon Metabolism Cofactor Supplements for the Treatment of Nonalcoholic Fatty Liver Disease (NAFLD)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 30, 2023 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
NAFLD

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
NAFLD Group
Arm Type
Experimental
Arm Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
homocysteine (Hcy) lowering supplements
Intervention Description
NAFLD participants will take homocysteine (Hcy) lowering supplements daily for 12 weeks.
Primary Outcome Measure Information:
Title
FibroScan-aspartate aminotransferase (FAST) score
Description
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).
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Feasibility as measured by percentage of completion of enrollment
Description
The trial design will be considered feasible if at least 13 NAFLD patients (≥80%) are enrolled over the 4-month period
Time Frame
4 months
Title
Assess safety of the trial.
Description
Based on reported adverse reactions.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
We will enroll NAFLD patients, blocked by age 50 years (≤ 50; > 50) and sex (M; F, four patients/subjects in each block). Inclusion Criteria for NAFLD Group: Increased hepatic fat accumulation diagnosed by either abdominal ultrasound or CT AND elevated CAP score of 280 dB/m or higher HOMA-IR ≥ 2 or the diagnosis of metabolic syndrome Chronic elevation of transaminases: ALT elevation (more than 2 times during the past 12 months, defined by 19 U/L for women and 30 U/L for men 31) Stable use of any potential anti-NASH therapy (i.e., vitamin E, pioglitazone, glucagon like peptide 1 agonist, etc.) for 6 months prior to screening. Aged 18+ years Able to provide legal consent Exclusion Criteria for NAFLD Group: Any contraindication to the study supplements Inability to obtain valid fibroscan measures at the screening Pregnancy or lactation Clinical diagnosis of cirrhosis or other chronic liver diseases Recent use of steatogenic medications Excess alcohol use (>21/ >14 drinks weekly in men/women) Chronic kidney disease Supplement use within 30 days, containing any of the study supplements Total parenteral nutrition Any clinical conditions associated with malabsorption Any active diagnosis of malignancy Use of immunosuppression
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ayako Suzuki
Phone
919-684-6211
Email
ayako.suzuki@duke.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ayako Suzuki
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chukwuemeka Oko
Phone
919-668-5499
Email
co129@duke.edu
First Name & Middle Initial & Last Name & Degree
Ayako Suzuki

12. IPD Sharing Statement

Learn more about this trial

A Feasibility Trial of OCM Supplements for the Treatment of NAFLD

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