Effects of Micro-dose and Low-dose Recombinant Human Erythropoietin on Mitochondrial Function and Cognitive Performance
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Maximal oxygen-flux (picomol/second)
研究概览
简要总结
A recent study by Plenge et al. revealed that rhEpo treatment enhances skeletal muscle mitochondrial respiratory capacity in humans indicating a muscle ergogenic effect of rhEpo on aerobic metabolism. The main purpose of the present study is to determine if a shorter treatment period with micro-dose as well as low-dose rhEpo has similar effects on muscle mitochondrial function.
Higher doses of rhEpo is known to increase cognitive performance, but it is not clear if lower doses of rhEpo have similar effects. A second purpose of the present study is to determine if micro-dose as well as low-dose rhEpo increases cognitive performance.
详细描述
Twenty-five healthy young male volunteers are randomized to either a low-dose rhEpo (60 IU/kg/week), micro-dose rhEpo (20 IU/kg/week), or placebo control (saline) group. All subjects receive two subcutaneous injections per week for four weeks. Muscle biopsies are taken at the beginning and end of the study period. Mitochondrial function is measured in permeabilized fibres using high-resolution respirometry with the substrates malate (2mM), octanoyl carnitine (1.5mM), glutamate (10mM), succinate (10mM), under saturating [ADP] (5mM), and with the membrane uncoupler FCCP (1μM).
On the first day before administration of rhEpo and after the four weeks' treatment the subjects are undergoing two cognitive performance-tests, Raven Standard Progressive Matrices (Raven), and Number Finder (NUFI). Weekly semi-structured interviews are conducted by a blinded interviewer focusing on experienced change in cognitive performance.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Normal medical examination
- •Weekly exercise for 0-5 hours
排除标准
- •Smoking daily
- •Earlier use of performance-enhancing drugs
- •Elite athletes
- •Presence of cardiovascular or metabolic disease
研究组 & 干预措施
Micro-dose rhEpo
RhEpo 20IU/kg/week
干预措施: Micro-dose rhEpo (Drug)
Placebo Control
Saline
干预措施: Placebo Control (Other)
Low-dose rhEpo
RhEpo 60IU/kg/week
干预措施: Low-dose rhEpo (Drug)
结局指标
主要结局
Maximal oxygen-flux (picomol/second)
时间窗: Four weeks
次要结局
- Sum of speed-score and accuracy-score in the RAVEN-test(Four weeks)
- Number of correctly found fields in the NUFI-test(Four weeks)
- Rating of the interviews on a scale from -3 to +3 according to experienced change in ability to concentrate(Four weeks)
研究者
Soeren Lundgaard Larsen
Physician
Bispebjerg Hospital