A Feasibility Trial of OCM Supplements for the Treatment of NAFLD

• Sponsor: Duke University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05720702
• Collaborator: (none)
• Enrollment: 20
• Arm: 1
• Anticipated Duration (Months): 10

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
NAFLD	Dietary Supplement: homocysteine (Hcy) lowering supplements	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Feasibility Trial of One-carbon Metabolism Cofactor Supplements for the Treatment of Nonalcoholic Fatty Liver Disease (NAFLD)
• Anticipated Study Start Date: Feb 1, 2023
• Anticipated Primary Completion Date: Dec 1, 2023
• Anticipated Study Completion Date: Dec 1, 2023

Arms and Interventions

Arm

Intervention/Treatment

Experimental: NAFLD Group 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

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

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

2. Assess safety of the trial. [12 weeks]

   Based on reported adverse reactions.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Duke University

Investigators

• Principal Investigator: Ayako Suzuki, Duke University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Duke University
• ClinicalTrials.gov Identifier: NCT05720702
• Other Study ID Numbers: Pro00112107
• First Posted: Feb 9, 2023
• Last Update Posted: Feb 9, 2023
• Last Verified: Jan 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Non-alcoholic Fatty Liver Disease

Study Results

No Results Posted as of Feb 9, 2023