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

Early Phase 1

Completed

• Conditions: Human Volunteers
• Interventions: Drug: Low-dose rhEpo; Drug: Micro-dose rhEpo; Other: Placebo Control

• Registration Number: NCT03093506
• Lead Sponsor: Bispebjerg Hospital

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.

Study Timeline

• Study Start: 2011-09
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Study First Submitted: 2015-01-08
• Status Verified: 2017-03
• Study First Submitted QC: 2017-03-22
• Last Update Submitted: 2017-03-22
• Study First Posted: 2017-03-28
• Last Update Posted: 2017-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low-dose rhEpo	Low-dose rhEpo	RhEpo 60IU/kg/week
Micro-dose rhEpo	Micro-dose rhEpo	RhEpo 20IU/kg/week
Placebo Control	Placebo Control	Saline

Primary Outcome Measures

Name	Time	Method
Maximal oxygen-flux (picomol/second)	Four weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Copenhagen University Hospital Bispebjerg, Department of Anaesthesiology; 🇩🇰 Copenhagen, Kbh NV, Denmark