Dietary Allowance of Methyl Donor Nutrients to Minimize Risks of Non-alcoholic Fatty Liver Progression: Novel Diagnostic and Therapeutic Markers in Metabolomics of Gut Microbiome/Host Methyl Nutrition and the Working Mechanisms
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Plasma methyl nutrients levels
研究概览
简要总结
Investigate the methyl donors requirement of NAFLD patients to correct the malnutrition, lipid-toxicity, microbiota dysfunction, and metabolomics biomarkers.
详细描述
Folate/choline/betaine, service as a methyl-donor nutrients, are essential nutrients involving in hepatic one-carbon and bioenergetic metabolism. Methyl-donor nutrients deficiency cause liver and muscle dysfunction as result of non-alcoholic fatty liver diseases (NAFLD) and its progressive lesions of steatohepatitis (NASH), fibrinogen cirrhosis and hepatoma. As methyl-donor nutrients intakes in Taiwanese population are highly insufficient, the dietary requirement of methyl-donor nutrients upon genetic, epigenetic and microbiota interaction to prevent or/and co-therapy of NAFLD progression is currently not known. In this study, we investigate whether intervention of methyl-donor nutrients improve or retard NAFLD progress. NAFLD patients are randomly divided into three groups and received placebo, folic acid, or choline, respectively. From first day to ten day, interventions are given double recommended daily intake dose of folic acid or double adequate Intakes dose of choline, then continuing with four times, and eight times dose for every 10 days. All supplements solve in cranberry juice. At the end of every ten days intervention prior, interventions are measurement of weight and body fat, and collection of blood and feces. The primary outcome measures are described to decreased body weight or body fat, improvement of liver function and fatty liver, and increasing methyl-donor nutrients levels.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 20 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •NAFLD/NASH patients
- •Folate levels in plasma < 6 ng/mL or choline levels in plasma < 5 micromol per liter
- •Folate intake < estimated average requirement or choline intake < 50% adequate Intakes
- •Homocysteine levels in plasma > 9 micromol per liter
排除标准
- •Asymptomatic carrier of hepatitis B and C
- •Liver disease except NAFLD
- •Taking drugs that causes fatty liver
- •Inflammation about stomach or intestines
- •Pregnancy
- •Cancer except liver cancer
- •Heart disease, vascular disease, or psychosis
- •Intake alcohol over 100 g or unaccessible intake alcohol
研究组 & 干预措施
Placebo
Interventions are not received any treatments.
Intervention
Interventions are received folic acid or choline
干预措施: Folic acid, choline chloride (Dietary Supplement)
结局指标
主要结局
Plasma methyl nutrients levels
时间窗: One month
Folate and choline concentration in plasma are detected to refer methyl nutrients levels. Methyl nutrients levels change after finishing intervention.
Body fat percentage
时间窗: One month
Body fat percentage are measured by using electronic body fat meter. Body fat percentage change after intervention.
Improvement liver dysfunction progress
时间窗: One month
To estimate liver dysfunction, we detect biochemical markers in plasma, including alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, and glutamyl transpeptidase. After finishing intervention, we assume improving liver function.
Liver fat proportion
时间窗: One month
To estimate hepatic fat content, interventions are detected fat content in liver by using MRI or abdominal ultrasound. We assume changing liver fat proportion after finishing intervention.
次要结局
- Change microbiota(One month)
研究者
Rwei-Fen Syu Huang
Professor
Fu Jen Catholic University
