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Completed

NCT Number: NCT03093506

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

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.

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Key information

Conditions

Human Volunteers

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Early Phase 1

Primary location

Copenhagen University Hospital Bispebjerg, Department of Anaesthesiology

Copenhagen, Kbh NV, 2400, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Low-dose rhEpo

Drug

60IU/kg/week

Other names: Recombinant Human Erythropoitin

Micro-dose rhEpo

Drug

20IU/kg/week

Other names: Recombinant Human Erythropoitin

Placebo control

Other

Saline

Other names: Saline

Primary outcomes

  1. Maximal oxygen-flux (picomol/second)

    Time frame: Four weeks

Secondary outcomes

  1. Sum of speed-score and accuracy-score in the RAVEN-test

    Time frame: Four weeks

  2. Number of correctly found fields in the NUFI-test

    Time frame: Four weeks

  3. Rating of the interviews on a scale from -3 to +3 according to experienced change in ability to concentrate

    Time frame: Four weeks

Sponsors and collaborators

Lead sponsor

Bispebjerg Hospital

Other

Registry information

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Mar 28, 2017
Registry last updated
Mar 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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