Low Glycemic Index Dietary Intervention Program in Nonalcoholic Fatty Liver Disease - A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 159
- 试验地点
- 1
- 主要终点
- Resolution of NAFLD by proton-magnetic resonance spectroscopy
研究概览
简要总结
Nonalcoholic fatty liver disease (NAFLD) is the most common chronic liver disease in affluent countries. It may progress to cirrhosis and liver cancer. At present, there is no approved drug for NAFLD. Although healthy diet and exercise is often recommended, there is little supportive evidence. Therefore, the investigators plan to conduct a randomized controlled trial comparing a low glycemic index dietary intervention program and simple lifestyle advice in NAFLD patients. The primary endpoint is resolution of NAFLD. Non-invasive tests will be used to assess the study subjects. Proton-magnetic resonance spectroscopy is used to quantify hepatic triglyceride content, and transient elastography is used to quantify liver fibrosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 70 years
- •Fatty liver by proton-magnetic resonance spectroscopy, defined as hepatic triglyceride content 5% or above
- •Serum alanine aminotransferase (ALT) above 30 U/L in men and 19 U/L in women
- •Informed written consent obtained
排除标准
- •Positive hepatitis B surface antigen, anti-hepatitis C virus antibody, or anti-nuclear antibody titer above 1/160
- •Alcohol consumption above 30 g per week in men or 20 g per week in women
- •Alanine aminotransferase (ALT) above 10 times the upper limit of normal
- •Liver decompensation, as evidenced by bilirubin above 50 µmol/l, platelet count below 100 × 10e9/l, prothrombin time above 1.3 times the upper limit of normal, albumin below 35 g/l, presence of ascites or varices
- •Evidence of hepatocellular carcinoma
- •Terminal illness or cancer, unless in complete remission for more than 5 years
结局指标
主要结局
Resolution of NAFLD by proton-magnetic resonance spectroscopy
时间窗: Month 12
次要结局
- Partial resolution of NAFLD(Month 12)
- Visceral fat measurement(Month 12)
- Liver fibrosis by transient elastography(Month 12)
- Metabolic endpoints(Month 12)
研究者
Henry LY Chan
Professor
Chinese University of Hong Kong