NCT01354626已完成不适用
Influence of Increasing Dietary Protein on Hepatic Fat Accumulation and Postprandial Metabolism
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- hepatic fat accumulation
研究概览
简要总结
The objective of this study is to investigate the potential beneficial effect of increasing protein in the diet in order to decrease hepatic lipid accumulation on a high-fat diet.
The investigators hypothesize that increasing protein in a high-fat diet suppresses lipid accumulation in the liver, and that changes in (hepatic) fat handling underlie this reduced lipid accumulation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •body mass index (BMI) 18-25 kg/ m2;
- •stable dietary habits;
- •physical activity levels.
- •caucasian
排除标准
- •Unable or unwilling to comply with study procedures;
- •not caucasian
- •Unstable body weight (weight gain or loss > 3 kg in the past three months);
- •Moderate intense physical activity (exercise) for more than 4 hours/week;
- •(Chronic) disease which might influence the study outcomes e.g. diabetes mellitus or any other endocrine disorder, active cardiovascular disease, hepatic disease, renal disease, cancer;
- •Family history of diabetes mellitus;
- •Use of medication, except incidental use of paracetamol;
- •Abuse of drugs;
- •Alcohol consumption of more than 14 glasses per week;
- •Participation in another biomedical study within 1 months prior to the first screening visit;
- •Contraindications to MRI scanning. These contraindications include patients with one of the following conditions:
- •Claustrophobia;
- •Central nervous system aneurysm clips;
- •Implanted neural stimulator;
- •Implanted cardiac pacemaker or defibrillator;
- •Cochlear implant;
- •Ocular foreign body (e.g. metal shavings);
- •Insulin pump;
- •Metal shrapnel or bullet;
- •Or metal containing corpora aliena in the eye of brains.
结局指标
主要结局
hepatic fat accumulation
时间窗: baseline, 2 weeks, 4 weeks
次要结局
- Postprandial lipid metabolism(2 weeks, 4 weeks)
- Peripheral blood mononuclear cells gene expression (PBMC's).(baseline, 2 weeks, 4 weeks)
- Circulating cytokines(baseline, 2 weeks, 4 weeks)
- Glucose homeostasis(baseline, 2 weeks, 4 weeks)
- Adipose tissue gene expression(2 weeks, 4 weeks)
- Biomarkers of liver function/hepatic steatosis(baseline, 2 weeks, 4 weeks)
研究者
研究点 (2)
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