The Effect of Micro-doses Erytropoietin on Exercise Capacity in Male and Females
Primary Purpose
Sports Drug Abuse
Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
EPO
Control group - saline injection
Sponsored by
About this trial
This is an interventional other trial for Sports Drug Abuse focused on measuring erythropoeitin, doping
Eligibility Criteria
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
Sites / Locations
- Department of Nutrition, Exercise and Sports
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Recombinant human erythropoietin treatment
Control group
Arm Description
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.
Participants receive intravenous injections of ~0,5 mL saline (NaCl 0,9%) three times per week for four weeks on non-consecutive days.
Outcomes
Primary Outcome Measures
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 in time trial performance
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 total hemoglobin mass 3 days after last injection. Measured by the carbon monoxide rebreathing method.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04965961
Brief Title
The Effect of Micro-doses Erytropoietin on Exercise Capacity in Male and Females
Official Title
Plasma and Exosome Proteomic Changes Associated With Augmented Erythropoiesis and Muscle Contractions.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 28, 2019 (Actual)
Primary Completion Date
May 17, 2021 (Actual)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Copenhagen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sports Drug Abuse
Keywords
erythropoeitin, doping
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Explorative
Masking
ParticipantInvestigator
Masking Description
An algorithm was created using randomizer.org
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Recombinant human erythropoietin treatment
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Participants receive intravenous injections of ~0,5 mL saline (NaCl 0,9%) three times per week for four weeks on non-consecutive days.
Intervention Type
Drug
Intervention Name(s)
EPO
Intervention Description
Please refer to the arm description
Intervention Type
Other
Intervention Name(s)
Control group - saline injection
Intervention Description
Please refer to the arm description
Primary Outcome Measure Information:
Title
Change in maximal oxygen uptake
Description
Change from baseline maximal aerobic capacity 5 days after last injection. Measured via an exhaustive incremental cycle ergometer test.
Time Frame
Change from baseline to 5 days after last injection
Title
Change in time trial performance
Description
Change from baseline endurance exercise performance 3 days after last injection. Measured via a preloaded 400 kcal time-trial.
Time Frame
Change from baseline to 3 days after last injection
Title
Change in total hemoglobin mass
Description
Change from baseline total hemoglobin mass 3 days after last injection. Measured by the carbon monoxide rebreathing method.
Time Frame
Change from baseline to 3 days after last injection
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Department of Nutrition, Exercise and Sports
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
Fully anonymous data can be shared with other researchers.
Learn more about this trial
The Effect of Micro-doses Erytropoietin on Exercise Capacity in Male and Females
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