A Feasibility Trial of OCM Supplements for the Treatment of NAFLD

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.

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 higherHOMA-IR ≥ 2 or the diagnosis of metabolic syndromeChronic 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+ yearsAble to provide legal consentExclusion Criteria for NAFLD Group:Any contraindication to the study supplementsInability to obtain valid fibroscan measures at the screeningPregnancy or lactationClinical diagnosis of cirrhosis or other chronic liver diseasesRecent use of steatogenic medicationsExcess alcohol use (>21/ >14 drinks weekly in men/women)Chronic kidney diseaseSupplement use within 30 days, containing any of the study supplementsTotal parenteral nutritionAny clinical conditions associated with malabsorptionAny active diagnosis of malignancyUse of immunosuppression