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

March 22, 2017 updated by: Soeren Lundgaard Larsen, Bispebjerg Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

25

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Kbh NV
      • Copenhagen, Kbh NV, Denmark, 2400
        • Copenhagen University Hospital Bispebjerg, Department of Anaesthesiology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Low-dose rhEpo
RhEpo 60IU/kg/week
Drug: Low-dose rhEpo
60IU/kg/week
Other Names:
  • Recombinant Human Erythropoitin
Active Comparator: Micro-dose rhEpo
RhEpo 20IU/kg/week
Drug: Micro-dose rhEpo
20IU/kg/week
Other Names:
  • Recombinant Human Erythropoitin
Placebo Comparator: Placebo Control
Saline
Other: Placebo Control
Saline
Other Names:
  • Saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Maximal oxygen-flux (picomol/second)
Time Frame: Four weeks
Four weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Sum of speed-score and accuracy-score in the RAVEN-test
Time Frame: Four weeks
Four weeks
Number of correctly found fields in the NUFI-test
Time Frame: Four weeks
Four weeks
Rating of the interviews on a scale from -3 to +3 according to experienced change in ability to concentrate
Time Frame: Four weeks
Four weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bispebjerg Hospital

Investigators

  • Principal Investigator: Soeren L. Larsen, Bispebjerg Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

January 8, 2015

First Submitted That Met QC Criteria

March 22, 2017

First Posted (Actual)

March 28, 2017

Study Record Updates

Last Update Posted (Actual)

March 28, 2017

Last Update Submitted That Met QC Criteria

March 22, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • H-1-2011-098

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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