Influence of Bed-Rest and Hypocaloric Nutrition on Endothelium-Dependent Vasoreactivity
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Drug-induced changes of forearm blood flow
研究概览
简要总结
Aim of the study is to assess the impact of the factors ´bed rest´ and ´hypocaloric nutrition´ on endothelium-dependent vasoreactivity in healthy volunteers.
详细描述
In a randomized, four-phase cross-over study the effect of simulated microgravity (13 days of bed rest), energetic restriction (-25%, fat reduced), and their combination on endothelium-dependent and -independent vasodilation will be compared with ambulatory control conditions. Using venous occlusion plethysmography cumulative intraarterial dose-response curves to endothelium-dependent (acetylcholine) and -independent (sodium nitroprusside) vasodilators will be constructed in 10 healthy male volunteers before and on day 13 of each of the four intervention periods.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Ect
- 盲法
- Single
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy, male volunteers, age: 18-40
- •Able and willing to give written informed consent
排除标准
- •Known condition causing endothelial dysfunction (e.g. diabetes, hyperlipidaemia, arterial hypertension, smoking, hyperhomocysteinaemia)
- •Regular medication and/or treatment with drugs within the last 4-6 weeks (exclusion has to be decided in each case)
- •Acute or chronic illness
- •Participation in clinical trial/blood donation within 2 month before the study
- •Nicotine during 1 year before the study; drug and/or alcohol abuse.
结局指标
主要结局
Drug-induced changes of forearm blood flow
次要结局
未报告次要终点