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

Sponsor
Bispebjerg Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03093506
Collaborator
(none)
25
Enrollment
1
Location
3
Arms
3
Duration (Months)
8.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Low-dose rhEpo
  • Drug: Micro-dose rhEpo
  • Other: Placebo Control
 Early Phase 1

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 Design

Study Type:
Interventional
Actual Enrollment :
25 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Basic Science
Official Title:
Effects of Micro-dose and Low-dose Recombinant Human Erythropoietin on Mitochondrial Function and Cognitive Performance
Study Start Date :
Sep 1, 2011
Actual Primary Completion Date :
Dec 1, 2011
Actual Study Completion Date :
Dec 1, 2011

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Maximal oxygen-flux (picomol/second) [Four weeks]

    Secondary Outcome Measures

    1. Sum of speed-score and accuracy-score in the RAVEN-test [Four weeks]

    2. Number of correctly found fields in the NUFI-test [Four weeks]

    3. Rating of the interviews on a scale from -3 to +3 according to experienced change in ability to concentrate [Four weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Copenhagen University Hospital Bispebjerg, Department of Anaesthesiology Copenhagen Kbh NV Denmark 2400

    Sponsors and Collaborators

    • Bispebjerg Hospital

    Investigators

    • Principal Investigator: Soeren L. Larsen, Bispebjerg Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Soeren Lundgaard Larsen, Physician, Bispebjerg Hospital
    ClinicalTrials.gov Identifier:
    NCT03093506
    Other Study ID Numbers:
    • H-1-2011-098
    First Posted:
    Mar 28, 2017
    Last Update Posted:
    Mar 28, 2017
    Last Verified:
    Mar 1, 2017
    Keywords provided by Soeren Lundgaard Larsen, Physician, Bispebjerg Hospital
    Erythropoietin
    Randomized controlled trial
    Human volunteers
    Mitochondrial function
    Cognitive performance

    Study Results

    No Results Posted as of Mar 28, 2017