A Feasibility Trial of OCM Supplements for the Treatment of NAFLD

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Primary Purpose

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

homocysteine (Hcy) lowering supplements

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

NCT ID

NCT05720702

First Posted

January 31, 2023

Last Updated

July 17, 2023

Sponsor

Duke University

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

NAFLD

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial