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

Bispebjerg Hospital

Status and phase: Completed; Early Phase 1

Conditions: Human Volunteers

Treatments: Other: Placebo Control; Drug: Low-dose rhEpo; Drug: Micro-dose rhEpo

Study type: Interventional

Funder types: Other

Identifiers

NCT03093506

H-1-2011-098

Details and patient eligibility

About

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.

Full 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.

Enrollment: 25 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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25 participants in 3 patient groups, including a placebo group

Low-dose rhEpo

Active Comparator group

Description:

RhEpo 60IU/kg/week

Treatment:

Drug: Low-dose rhEpo

Micro-dose rhEpo

Active Comparator group

Description:

RhEpo 20IU/kg/week

Treatment:

Drug: Micro-dose rhEpo

Placebo Control

Placebo Comparator group

Description:

Saline

Treatment:

Other: Placebo Control