A Randomized Controlled Study on the Incretin Effect, Cognitive Function and Controlled Fasting During Bed Rest in Healthy Male Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Cognitive function
研究概览
简要总结
Bed rest produces insulin resistance in healthy volunteers. In this study the investigators aim to investigate the effect of 8 days bed rest on the incretin effect and how alternate daily fasting affects cognitive function and the insulin resistance produced by bed rest.
The subjects will be randomized to either 3 meals a day (isocaloric diet), alternate daily fasting or one meal/day every second day (25% of daily calorie need) and four meals/day every second (175% of daily calorie need).
The investigators hypothesize:
- Bed rest reduces the incretin effect
- Alternate daily fasting improves the cognitive function (memory and concentration) compared to isocaloric diet
- Alternate daily fasting reduces insulin resistance produced by bed rest compared to isocaloric diet
详细描述
All subjects will undergo 8 days of bedrest. Outcome measures will be performed before, under and immediately after the bed rest period.
The individual study period will be 10 days in total.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •BMI<25kg/m2
- •VO2 max normal for age
排除标准
- •Tobacco smoking
- •Alcohol ingestion > 14 units per week
- •Diabetes in nearby relatives
- •Resection of the small intestine
- •History of gastric bypass surgery
- •Risk of deep venous thrombosis
研究组 & 干预措施
Isocaloric diet
3 daily meals
干预措施: Bed rest (Other)
Isocaloric diet
3 daily meals
干预措施: OGTT (Other)
Isocaloric diet
3 daily meals
干预措施: IVGTT (Other)
Isocaloric diet
3 daily meals
干预措施: Cognitive testing (Other)
Isocaloric diet
3 daily meals
干预措施: Muscle and fat biopsies (Other)
Isocaloric diet
3 daily meals
干预措施: Dual-energy X-ray Absorptiometry (DXA) scan (Other)
Isocaloric diet
3 daily meals
干预措施: MRI (Other)
Alternate daily fasting
One meal (25% of caloric need) every second day and four meals (175% of caloric need) every second day
干预措施: Bed rest (Other)
Alternate daily fasting
One meal (25% of caloric need) every second day and four meals (175% of caloric need) every second day
干预措施: OGTT (Other)
Alternate daily fasting
One meal (25% of caloric need) every second day and four meals (175% of caloric need) every second day
干预措施: IVGTT (Other)
Alternate daily fasting
One meal (25% of caloric need) every second day and four meals (175% of caloric need) every second day
干预措施: Cognitive testing (Other)
Alternate daily fasting
One meal (25% of caloric need) every second day and four meals (175% of caloric need) every second day
干预措施: Muscle and fat biopsies (Other)
Alternate daily fasting
One meal (25% of caloric need) every second day and four meals (175% of caloric need) every second day
干预措施: Dual-energy X-ray Absorptiometry (DXA) scan (Other)
Alternate daily fasting
One meal (25% of caloric need) every second day and four meals (175% of caloric need) every second day
干预措施: MRI (Other)
结局指标
主要结局
Cognitive function
时间窗: 18 months
Evaluated by cognitive testing and functional Magnetic Resonance imaging (MRI)
Incretin effect
时间窗: 24 weeks
Measured by Insulin levels during Oral glucose tolerance test (OGTT) and Intravenous glucose tolerance test (IVGTT)
Insulin resistance
时间窗: 12 weeks
Evaluated by insulin resistance indexes, HOMA-IR and Matsuda index
次要结局
未报告次要终点
研究者
Anders Rasmussen Rinnov
MD, PhD
Rigshospitalet, Denmark