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

Not Applicable

Active, not recruiting

• Conditions: Sports Drug Abuse
• Interventions: Drug: EPO; Other: Control group - saline injection

• Registration Number: NCT04965961
• Lead Sponsor: University of Copenhagen

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.

Study Timeline

• Study Start: 2019-08-28
• Primary Completion: 2021-05-17
• Study First Submitted: 2021-06-28
• Study First Submitted QC: 2021-07-08
• Study First Posted: 2021-07-16
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-28
• Last Update Posted: 2023-11-29
• Study Completion: 2024-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Recombinant human erythropoietin treatment	EPO	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.
Control group	Control group - saline injection	Participants receive intravenous injections of \~0,5 mL saline (NaCl 0,9%) three times per week for four weeks on non-consecutive days.

Primary Outcome Measures

Name	Time	Method
Change in time trial performance	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	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	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.

Trial Locations

Locations (1)

Department of Nutrition, Exercise and Sports; 🇩🇰 Copenhagen, Denmark