A Feasibility Trial of OCM Supplements for the Treatment of NAFLD

NCT05720702 | Completed Early Phase 1

• 1 other identifier: Pro00112107
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

NAFLD

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Feasibility as measured by percentage of completion of enrollment

  4 months

• Assess safety of the trial.

  12 weeks

Study Arms (1)

NAFLD Group

EXPERIMENTAL

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

Interventions

homocysteine (Hcy) lowering supplements DIETARY_SUPPLEMENT

NAFLD participants will take homocysteine (Hcy) lowering supplements daily for 12 weeks.

NAFLD Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

Homocysteine

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Ayako Suzuki

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2023
• First Posted: February 9, 2023
• Study Start: June 30, 2023
• Primary Completion: August 23, 2024
• Study Completion: August 23, 2024
• Last Updated: November 27, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)