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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03093506
Study type Interventional
Source Bispebjerg Hospital
Contact
Status Completed
Phase Early Phase 1
Start date September 2011
Completion date December 2011

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