The Role of Dietary Carbohydrate and Fat Availability in the Regulation of Hepatic Lipid Content
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Liverfat
研究概览
简要总结
The purpose of this study is to investigate dietary compositions effect on liverfat measured by magnetic resonance imaging.
详细描述
Overweight but otherwise healthy men will be included in the study which is a randomized diet intervention study in a cross over design.
The study involves 2 intervention periods of 5 days each, during which the participant ingests two different types of experimental diet. Participants will in randomized order (determined by block randomization) ingest a diet with low carbohydrate and high fat content, and a diet with high carbohydrate and low fat content.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy men being 18-50 years old.
- •Overweight (BMI 25-35)
- •Low to moderate physical activity level, defined as ≤ 1 weekly session of aerobic exercise.
- •Non-smokers
- •No use of medicine
排除标准
- •Fasting blood glucose indicating overt diabetes (≥7 mmol/l)
- •HbA1C >48 mmol/mol
- •Fasting plasma triacylglycerol indicating dyslipidemia (≥2.2 mmol/l)
- •FIB-4 score >1.45
- •Contraindications for MR-scan: abdominal height exceed limitations of the MR-scanner, pacemaker or other electronic device implanted, implanted metal devices, severe claustrophobia.
结局指标
主要结局
Liverfat
时间窗: (MRS Day -1 (before intervention starts), Day 5 (after diet intervention is completed)
The effect of high-carbohydrate/low-fat vs low-carbohydrate/high-fat diet on change in MRS determined liver fat.
次要结局
- Glycogen((MRS Day -1 (before intervention starts), Day 5 (after diet intervention is completed))
- fasting blood triacylglycerol concentration((Day 0 and Day 6 of the diet intervention))
- Insulin clearance determined during steady state insulin infusion((Day 0 and Day 6 of the diet intervention))
- fasting hepatic glucose output((Day 0 and Day 6 of the diet intervention))
研究者
Kirstine Nyvold Bojsen-Moeller
Principal investigator, MD, PhD
Hvidovre University Hospital