Human Volunteers Clinical Trial
Official title:
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.
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.
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