The Effect of Micro-doses Erytropoietin on Exercise Capacity in Male and Females
November 28, 2023 updated by: Nikolai Nordsborg, University of Copenhagen
Plasma and Exosome Proteomic Changes Associated With Augmented Erythropoiesis and Muscle Contractions.
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
48
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Copenhagen, Denmark, 2100
- Department of Nutrition, Exercise and Sports
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Recombinant human erythropoietin treatment
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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Please refer to the arm description
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Placebo Comparator: Control group
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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Please refer to the arm description
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in maximal oxygen uptake
Time Frame: Change from baseline to 5 days after last injection
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Change from baseline maximal aerobic capacity 5 days after last injection.
Measured via an exhaustive incremental cycle ergometer test.
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Change from baseline to 5 days after last injection
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Change in time trial performance
Time Frame: Change from baseline to 3 days after last injection
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Change from baseline endurance exercise performance 3 days after last injection.
Measured via a preloaded 400 kcal time-trial.
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Change from baseline to 3 days after last injection
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Change in total hemoglobin mass
Time Frame: Change from baseline to 3 days after last injection
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Change from baseline total hemoglobin mass 3 days after last injection.
Measured by the carbon monoxide rebreathing method.
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Change from baseline to 3 days after last injection
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 28, 2019
Primary Completion (Actual)
May 17, 2021
Study Completion (Estimated)
January 1, 2024
Study Registration Dates
First Submitted
June 28, 2021
First Submitted That Met QC Criteria
July 8, 2021
First Posted (Actual)
July 16, 2021
Study Record Updates
Last Update Posted (Actual)
November 29, 2023
Last Update Submitted That Met QC Criteria
November 28, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- H-18013069
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
Fully anonymous data can be shared with other researchers.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.