NCT02491229已完成不适用
Clinical Trial for Investigating the Effects of "Hepafast" on Non-alcoholic Fatty Liver Disease (NAFLD)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- change from baseline in hepatorenal index at two weeks, six weeks and twelve weeks after starting a defined way of nutrition
研究概览
简要总结
The purpose of this study is to investigate whether a weight reduction with "Hepafast" in combination with raw food and vegetables for two weeks followed by a meal substitution with "Hepafast" and a calorie restriction in accordance with the Low Glycemic and Insulinemic Diet (LOGI) for 10 weeks is superior regarding improvement of non-alcoholic Fatty Liver Disease (NAFLD) compared to a conventional weight reduction in accordance with the LOGI diet without use of "Hepafast" for 12 weeks.
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI between 30-40 kg/m2
- •suspected or diagnosed non-alcoholic fatty liver disease (NAFLD)
排除标准
- •other liver diseases
- •kidney failure
- •pregnancy, lactation
- •diabetes mellitus which is treated with insulin
- •alcohol abuse
- •several drugs
结局指标
主要结局
change from baseline in hepatorenal index at two weeks, six weeks and twelve weeks after starting a defined way of nutrition
时间窗: Participants will be followed for the time of twelve weeks. Examinations take place at two weeks, six weeks and twelve weeks.
次要结局
- change from baseline in blood pressure (systolic and diastolic) at two weeks, six weeks and twelve weeks after starting a defined way of nutrition(Participants will be followed for the time of twelve weeks. Examinations take place at two weeks, six weeks and twelve weeks.)
- change from baseline in fatty liver index at two weeks, six weeks and twelve weeks after starting a defined way of nutrition(Participants will be followed for the time of twelve weeks. Examinations take place at two weeks, six weeks and twelve weeks.)
- change from baseline in GGT at two weeks, six weeks and twelve weeks after starting a defined way of nutrition(Participants will be followed for the time of twelve weeks. Examinations take place at two weeks, six weeks and twelve weeks.)
- change from baseline in GPT at two weeks, six weeks and twelve weeks after starting a defined way of nutrition(Participants will be followed for the time of twelve weeks. Examinations take place at two weeks, six weeks and twelve weeks.)
- change from baseline in triglycerides at two weeks, six weeks and twelve weeks after starting a defined way of nutrition(Participants will be followed for the time of twelve weeks. Examinations take place at two weeks, six weeks and twelve weeks.)
- change from baseline in the classification of non-alcoholic fatty liver disease (NAFLD) based on ultrasound at two weeks, six weeks and twelve weeks after starting a defined way of nutrition(Participants will be followed for the time of twelve weeks. Examinations take place at two weeks, six weeks and twelve weeks.)
- change from baseline in HbA1c at two weeks, six weeks and twelve weeks after starting a defined way of nutrition(Participants will be followed for the time of twelve weeks. Examinations take place at two weeks, six weeks and twelve weeks.)
- change from baseline in hsCRP at two weeks, six weeks and twelve weeks after starting a defined way of nutrition(Participants will be followed for the time of twelve weeks. Examinations take place at two weeks, six weeks and twelve weeks.)
- change from baseline in body weight at two weeks, six weeks and twelve weeks after starting a defined way of nutrition(Examinations take place at two weeks, six weeks and twelve weeks.)
- change from baseline in GOT at two weeks, six weeks and twelve weeks after starting a defined way of nutrition(Participants will be followed for the time of twelve weeks. Examinations take place at two weeks, six weeks and twelve weeks.)
- change from baseline in AP at two weeks, six weeks and twelve weeks after starting a defined way of nutrition(Participants will be followed for the time of twelve weeks. Examinations take place at two weeks, six weeks and twelve weeks.)
- change from baseline in HDL cholesterol at two weeks, six weeks and twelve weeks after starting a defined way of nutrition(Participants will be followed for the time of twelve weeks. Examinations take place at two weeks, six weeks and twelve weeks.)
- change from baseline in fasting glucose at two weeks, six weeks and twelve weeks after starting a defined way of nutrition(Participants will be followed for the time of twelve weeks. Examinations take place at two weeks, six weeks and twelve weeks.)
- change from baseline in insulin at two weeks, six weeks and twelve weeks after starting a defined way of nutrition(Participants will be followed for the time of twelve weeks. Examinations take place at two weeks, six weeks and twelve weeks.)
- change from baseline in LDL cholesterol at two weeks, six weeks and twelve weeks after starting a defined way of nutrition(Participants will be followed for the time of twelve weeks. Examinations take place at two weeks, six weeks and twelve weeks.)
研究者
Stephan C. Bischoff, MD, Professor
Stephan C. Bischoff, MD, Professor
University of Hohenheim
研究点 (2)
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