Effects of Micro-dose and Low-dose Recombinant Human Erythropoietin on Mitochondrial Function and Cognitive Performance
1 other identifier
interventional
25
1 country
1
Brief Summary
A recent study by Plenge et al. revealed that rhEpo treatment enhances skeletal muscle mitochondrial respiratory capacity in humans indicating a muscle ergogenic effect of rhEpo on aerobic metabolism. The main purpose of the present study is to determine if a shorter treatment period with micro-dose as well as low-dose rhEpo has similar effects on muscle mitochondrial function. Higher doses of rhEpo is known to increase cognitive performance, but it is not clear if lower doses of rhEpo have similar effects. A second purpose of the present study is to determine if micro-dose as well as low-dose rhEpo increases cognitive performance.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for early_phase_1
Started Sep 2011
Shorter than P25 for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedFirst Submitted
Initial submission to the registry
January 8, 2015
CompletedFirst Posted
Study publicly available on registry
March 28, 2017
CompletedMarch 28, 2017
March 1, 2017
3 months
January 8, 2015
March 22, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Maximal oxygen-flux (picomol/second)
Four weeks
Secondary Outcomes (3)
Sum of speed-score and accuracy-score in the RAVEN-test
Four weeks
Number of correctly found fields in the NUFI-test
Four weeks
Rating of the interviews on a scale from -3 to +3 according to experienced change in ability to concentrate
Four weeks
Study Arms (3)
Low-dose rhEpo
ACTIVE COMPARATORRhEpo 60IU/kg/week
Micro-dose rhEpo
ACTIVE COMPARATORRhEpo 20IU/kg/week
Placebo Control
PLACEBO COMPARATORSaline
Interventions
Eligibility Criteria
You may qualify if:
- Normal medical examination
- Weekly exercise for 0-5 hours
You may not qualify if:
- Smoking daily
- Earlier use of performance-enhancing drugs
- Elite athletes
- Presence of cardiovascular or metabolic disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Copenhagen University Hospital Bispebjerg, Department of Anaesthesiology
Copenhagen, Kbh NV, 2400, Denmark
Related Publications (2)
Plenge U, Belhage B, Guadalupe-Grau A, Andersen PR, Lundby C, Dela F, Stride N, Pott FC, Helge JW, Boushel R. Erythropoietin treatment enhances muscle mitochondrial capacity in humans. Front Physiol. 2012 Mar 13;3:50. doi: 10.3389/fphys.2012.00050. eCollection 2012.
PMID: 22419911BACKGROUNDViuff SL, Plenge U, Belhage B, Boushel R, Koester T. Effects of low-dose recombinant human erythropoietin treatment on cognitive performance. Dan Med J. 2017 Sep;64(9):A5403.
PMID: 28874242DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Soeren L. Larsen
Bispebjerg Hospital
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Physician
Study Record Dates
First Submitted
January 8, 2015
First Posted
March 28, 2017
Study Start
September 1, 2011
Primary Completion
December 1, 2011
Study Completion
December 1, 2011
Last Updated
March 28, 2017
Record last verified: 2017-03