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

Sports Drug Abuse Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04965961
• Other study ID #: H-18013069
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 28, 2019
• Est. completion date: January 2024

Study information

• Verified date: November 2023
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 48
• Est. completion date: January 2024
• Est. primary completion date: May 17, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Sports Drug Abuse
• Substance-Related Disorders

Intervention

Drug:
• EPO
Please refer to the arm description

Other:
• Control group - saline injection
Please refer to the arm description

Locations

Country	Name	City	State
Denmark	Department of Nutrition, Exercise and Sports	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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