A Feasibility Trial of OCM Supplements for the Treatment of NAFLD

NAFLD Clinical Trial

Official title:

A Feasibility Trial of One-carbon Metabolism Cofactor Supplements for the Treatment of Nonalcoholic Fatty Liver Disease (NAFLD)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05720702
• Other study ID #: Pro00112107
• Status: Recruiting
• Phase: N/A
• Start date: June 30, 2023
• Est. completion date: October 2024

Study information

• Verified date: April 2024
• Source: Duke University
• Contact: Ayako Suzuki
• Phone: 919-684-6211
• Email: ayako.suzuki[@]duke.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

1. Increased hepatic fat accumulation diagnosed by either abdominal ultrasound or CT AND elevated CAP score of 280 dB/m or higher

2. HOMA-IR = 2 or the diagnosis of metabolic syndrome

3. 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)

4. 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.

5. Aged 18+ years

6. Able to provide legal consent

Exclusion Criteria for NAFLD Group:

1. Any contraindication to the study supplements

2. Inability to obtain valid fibroscan measures at the screening

3. Pregnancy or lactation

4. Clinical diagnosis of cirrhosis or other chronic liver diseases

5. Recent use of steatogenic medications

6. Excess alcohol use (>21/ >14 drinks weekly in men/women)

7. Chronic kidney disease

8. Supplement use within 30 days, containing any of the study supplements

9. Total parenteral nutrition

10. Any clinical conditions associated with malabsorption

11. Any active diagnosis of malignancy

12. Use of immunosuppression

Related Conditions & MeSH terms

• NAFLD
• Non-alcoholic Fatty Liver Disease

Intervention

Dietary Supplement:
• homocysteine (Hcy) lowering supplements
NAFLD participants will take homocysteine (Hcy) lowering supplements daily for 12 weeks.

Locations

Country	Name	City	State
United States	Duke University	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	12 weeks
Secondary	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	4 months
Secondary	Assess safety of the trial.	Based on reported adverse reactions.	12 weeks