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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Recombinant human erythropoietin treatment | Experimental | 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. |
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| Control group | Placebo Comparator | Participants receive intravenous injections of ~0,5 mL saline (NaCl 0,9%) three times per week for four weeks on non-consecutive days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EPO | Drug | Please refer to the arm description |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in maximal oxygen uptake | Change from baseline maximal aerobic capacity 5 days after last injection. Measured via an exhaustive incremental cycle ergometer test. | Change from baseline to 5 days after last injection |
| Change in time trial performance | Change from baseline endurance exercise performance 3 days after last injection. Measured via a preloaded 400 kcal time-trial. | Change from baseline to 3 days after last injection |
| Change in total hemoglobin mass | Change from baseline total hemoglobin mass 3 days after last injection. Measured by the carbon monoxide rebreathing method. | Change from baseline to 3 days after last injection |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Nutrition, Exercise and Sports | Copenhagen | 2100 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37095637 | Derived | Breenfeldt Andersen A, Bejder J, Bonne TC, Graae J, Seier S, Nordsborg NB. Changes in Immature Reticulocytes Aid the Indirect Detection of Microdose Recombinant Erythropoietin Use in Men and Women. Med Sci Sports Exerc. 2023 Sep 1;55(9):1695-1705. doi: 10.1249/MSS.0000000000003197. Epub 2023 Apr 24. | |
| 36317927 | Derived |
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Fully anonymous data can be shared with other researchers.
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Explorative
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An algorithm was created using randomizer.org
| Control group - saline injection |
| Other |
Please refer to the arm description |
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| Breenfeldt Andersen A, Graae J, Bejder J, Bonne TC, Seier S, Debertin M, Eibye K, Hostrup M, Nordsborg NB. Microdoses of Recombinant Human Erythropoietin Enhance Time Trial Performance in Trained Males and Females. Med Sci Sports Exerc. 2023 Feb 1;55(2):311-321. doi: 10.1249/MSS.0000000000003052. Epub 2022 Nov 1. |