NCT04355910Unknown不适用
Effects of Intermittent and Continuous Calorie Restriction on Body Weight and Metabolism in Adults With Nonalcoholic Fatty Liver Disease
Shaoguan University1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2018年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Body weight
研究概览
简要总结
Although preliminary evidence suggests that intermittent fasting mimic-diet (IFD) exerts stronger effects on body weight and metabolic parameters, which may link obesity, non-alcoholic fatty liver disease (NAFLD) and major chronic diseases, compared with continuous calorie restriction (CCR), there is a lack of well-powered intervention studies. This randomized controlled trial will test whether IFD, operationalized as the "5:2 diet," has stronger effects on anthropometric and body composition characteristics, and circulating metabolic biomarkers than CCR and a control regimen in adults with NAFLD.
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
- Single (Outcomes Assessor)
盲法说明
The patient is represented in code
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The diagnosed criteria of fatty liver by ultrasound were presence of two of the three following criteria: increased hepatic echogenicity compared with cortical of the right kidney, blurring of liver vasculature, and deep attenuation of the ultrasonographic signal.
排除标准
- •Excessive alcohol consumption (ethanol > 140 g/wk for men and > 70 g/wk for women), cirrhosis, viral hepatitis, cardiovascular disease, cancer, any consumption of nonsteroidal anti-inflammatory drugs, corticosteroids or prescriptive medicine that affect liver function, lipid and glucose metabolism.
结局指标
主要结局
Body weight
时间窗: Change from baseline body weight at week 8
Change of body weight
次要结局
- Gut microbiota(Change from baseline plasma bile acids and the gut microbiome at week 8)
- Insulin resistance(Change from baseline plasma glucose and insulin at week 8)
- Lipid profile(Change from baseline plasma TG, TC and LDL at week 8)
研究者
研究点 (1)
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