Clinical trial NCT05720702: 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
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: NAFLD
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2023-02-09
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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:

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

Primary outcomes:
measure: FibroScan-aspartate aminotransferase (FAST) score
timeFrame: 12 weeks
Secondary outcomes:
measure: Feasibility as measured by percentage of completion of enrollment
timeFrame: 4 months
measure: Assess safety of the trial.
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University
state: North Carolina
Study officials:
affiliation: Duke University
name: Ayako Suzuki
role: PRINCIPAL_INVESTIGATOR
References: