A Feasibility Trial of One-carbon Metabolism Cofactor Supplements for the Treatment of Nonalcoholic Fatty Liver Disease (NAFLD)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- FibroScan-aspartate aminotransferase (FAST) score
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 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
排除标准
- •for NAFLD Group:
- •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
结局指标
主要结局
FibroScan-aspartate aminotransferase (FAST) score
时间窗: 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).
次要结局
- Feasibility as measured by percentage of completion of enrollment(4 months)
- Assess safety of the trial.(12 weeks)