Non-erythroid Effects of Erythropoietin on Cognitive Function and Exercise Capacity in Humans
试验速览
- 阶段
- 1 期
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Cognitive Function
研究概览
简要总结
The blood hormone Erythropoietin (Epo) is not only produced by the kidneys but also by the brain, especially under hypoxic conditions. It has been shown in animal studies and human studies that Epo has neuroprotective properties. Furthermore, there is scientific evidence for central modulatory effects of Epo in the brain but high dose of Epo is needed to overcome the blood brain barrier. In a double blind placebo controlled crossover study we will investigate the effects of a single high dose of Epo on cognitive function and exercise capacity in healthy subjects. The subjects will receive a single high dose of Epo (60.000 IU) and will perform a computerized cognitive test battery, a breathing test, a maximal exercise capacity test (VO2max), and a time trial (TT) 24 hours after the treatment. The primary outcome of the study will be the cognitive function.
- Trial with medicinal product
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
0.9% sodium chloride solution
Short infusion of 0.9% sodium chloride solution (250 ml)
干预措施: Placebo (Drug)
Erythropoietin (Epoetin beta)
Short infusion of 60.000 IU Epoetin beta in 0.9% sodium chloride solution (250 ml)
干预措施: Erythropoietin (Epoetin beta) (Drug)
结局指标
主要结局
Cognitive Function
时间窗: 1 year
The following parameters of cognitive function will be tested via computer-based cognitive testing (Units: Scores, Percent Correct, Response time): * Working memory capacity * Executive function * Processing speed
次要结局
- Exercise Capacity(1 year)