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

Human Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03093506
• Other study ID #: H-1-2011-098
• Status: Completed
• Phase: Early Phase 1
• First received: January 8, 2015
• Last updated: March 22, 2017
• Start date: September 2011
• Est. completion date: December 2011

Study information

• Verified date: March 2017
• Source: Bispebjerg Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Human Volunteers

Intervention

Drug:
• Low-dose rhEpo
60IU/kg/week
• Micro-dose rhEpo
20IU/kg/week

Other:
• Placebo Control
Saline

Locations

Country	Name	City	State
Denmark	Copenhagen University Hospital Bispebjerg, Department of Anaesthesiology	Copenhagen	Kbh NV

Sponsors (1)

Lead Sponsor	Collaborator
Bispebjerg Hospital

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

Plenge U, Belhage B, Guadalupe-Grau A, Andersen PR, Lundby C, Dela F, Stride N, Pott FC, Helge JW, Boushel R. Erythropoietin treatment enhances muscle mitochondrial capacity in humans. Front Physiol. 2012 Mar 13;3:50. doi: 10.3389/fphys.2012.00050. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximal oxygen-flux (picomol/second)		Four weeks
Secondary	Sum of speed-score and accuracy-score in the RAVEN-test		Four weeks
Secondary	Number of correctly found fields in the NUFI-test		Four weeks
Secondary	Rating of the interviews on a scale from -3 to +3 according to experienced change in ability to concentrate		Four weeks