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The Effect of Micro-doses Erytropoietin on Exercise Capacity in Male and Females

Plasma and Exosome Proteomic Changes Associated With Augmented Erythropoiesis and Muscle Contractions.

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04965961
Enrollment
48
Registered
2021-07-16
Start date
2019-08-28
Completion date
2024-01-31
Last updated
2023-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sports Drug Abuse

Keywords

erythropoeitin, doping

Brief summary

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.

Detailed description

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.

Interventions

DRUGEPO

Please refer to the arm description

OTHERControl group - saline injection

Please refer to the arm description

Sponsors

University of Copenhagen
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)

Masking description

An algorithm was created using randomizer.org

Intervention model description

Explorative

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* Age * Insufficient fitness level * Blood donation 3 months prior to enrollment * Altitude exposure 2 months before enrollment * Hypertension

Design outcomes

Primary

MeasureTime frameDescription
Change in maximal oxygen uptakeChange from baseline to 5 days after last injectionChange from baseline maximal aerobic capacity 5 days after last injection. Measured via an exhaustive incremental cycle ergometer test.
Change in time trial performanceChange from baseline to 3 days after last injectionChange from baseline endurance exercise performance 3 days after last injection. Measured via a preloaded 400 kcal time-trial.
Change in total hemoglobin massChange from baseline to 3 days after last injectionChange from baseline total hemoglobin mass 3 days after last injection. Measured by the carbon monoxide rebreathing method.

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026