Plasma and Exosome Proteomic Changes Associated With Augmented Erythropoiesis and Muscle Contractions.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Change in time trial performance
研究概览
简要总结
Recombinant human erythropoietin (rHuEPO) regimen enhances maximal oxygen consumption (VO2max), but the effect of micro-doses on maximal and submaximal performance is not clear and detection of micro-doses is difficult with current methods. This study investigated whether micro-doses of rHuEPO enhances maximal and endurance performance in males and females.
详细描述
In a randomized, double-blind, placebo-controlled design, 48 trained adults (24 females, 24 males) receive either recombinant human erythropoietin (rHuEPO; epoetin-β, 9 IU/kg, n = 24, (12 females, 12 males)) or placebo (0,9% NaCl, n = 24, (12 females, 12 males)) three times per week for four weeks. Before the intervention, time trial performance and maximal oxygen uptake will be assessed. Three and five days after the last injection, time trial performance and maximal oxygen uptake will be determined to assess the effect of the rHuEPO administration. In addition, total hemoglobin mass and intravascular volumes will be determined via the carbon monoxide rebreathing method in duplicate measures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
盲法说明
An algorithm was created using randomizer.org
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Relative maximum oxygen uptake (VO2-max) of at least 50 ml O2/min/kg for male participants and 45 ml O2/min/kg for female participants
排除标准
- •Insufficient fitness level
- •Blood donation 3 months prior to enrollment
- •Altitude exposure 2 months before enrollment
- •Hypertension
研究组 & 干预措施
Recombinant human erythropoietin treatment
Participants receive intravenous injections of 9 International Units per kg bodyweight epoetin-β (NeoRecormon, Roche, Mannheim, Germany) three times per week for four weeks on non-consecutive days. Subjects receive tablets with 80mg iron (Tardyferon, Pierre Fabre Pharme GmbH, Freiburg, Germany) to ensure sufficient iron stores for the expected increase in erythropoeisis.
干预措施: EPO (Drug)
Control group
Participants receive intravenous injections of ~0,5 mL saline (NaCl 0,9%) three times per week for four weeks on non-consecutive days.
干预措施: Control group - saline injection (Other)
结局指标
主要结局
Change in time trial performance
时间窗: Change from baseline to 3 days after last injection
Change from baseline endurance exercise performance 3 days after last injection. Measured via a preloaded 400 kcal time-trial.
Change in total hemoglobin mass
时间窗: Change from baseline to 3 days after last injection
Change from baseline total hemoglobin mass 3 days after last injection. Measured by the carbon monoxide rebreathing method.
Change in maximal oxygen uptake
时间窗: Change from baseline to 5 days after last injection
Change from baseline maximal aerobic capacity 5 days after last injection. Measured via an exhaustive incremental cycle ergometer test.
次要结局
未报告次要终点
研究者
Nikolai Nordsborg
Professor, Head of Department
University of Copenhagen