Effects of Micro-dose and Low-dose Recombinant Human Erythropoietin on Mitochondrial Function and Cognitive Performance

Status

Completed

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03093506

Enrollment

Registered

2017-03-28

Start date

2011-09-30

Completion date

2011-12-31

Last updated

2017-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Human Volunteers

Keywords

Erythropoietin, Randomized controlled trial, Human volunteers, Mitochondrial function, Cognitive performance

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.

Detailed description

Twenty-five healthy young male volunteers are randomized to either a low-dose rhEpo (60 IU/kg/week), micro-dose rhEpo (20 IU/kg/week), or placebo control (saline) group. All subjects receive two subcutaneous injections per week for four weeks. Muscle biopsies are taken at the beginning and end of the study period. Mitochondrial function is measured in permeabilized fibres using high-resolution respirometry with the substrates malate (2mM), octanoyl carnitine (1.5mM), glutamate (10mM), succinate (10mM), under saturating \[ADP\] (5mM), and with the membrane uncoupler FCCP (1μM). On the first day before administration of rhEpo and after the four weeks' treatment the subjects are undergoing two cognitive performance-tests, Raven Standard Progressive Matrices (Raven), and Number Finder (NUFI). Weekly semi-structured interviews are conducted by a blinded interviewer focusing on experienced change in cognitive performance.

Interventions

DRUGLow-dose rhEpo

60IU/kg/week

DRUGMicro-dose rhEpo

20IU/kg/week

OTHERPlacebo Control

Saline

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

MALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

* Normal medical examination * Weekly exercise for 0-5 hours

Exclusion criteria

* Smoking daily * Earlier use of performance-enhancing drugs * Elite athletes * Presence of cardiovascular or metabolic disease

Design outcomes

Primary

Measure	Time frame
Maximal oxygen-flux (picomol/second)	Four weeks

Secondary

Measure	Time frame
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

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026