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

NCT ID: NCT03093506

Last Updated: 2017-03-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2011-12-31

Brief Summary

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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

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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.

Conditions

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Human Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Low-dose rhEpo

RhEpo 60IU/kg/week

Group Type ACTIVE_COMPARATOR

Low-dose rhEpo

Intervention Type DRUG

60IU/kg/week

Micro-dose rhEpo

RhEpo 20IU/kg/week

Group Type ACTIVE_COMPARATOR

Micro-dose rhEpo

Intervention Type DRUG

20IU/kg/week

Placebo Control

Saline

Group Type PLACEBO_COMPARATOR

Placebo Control

Intervention Type OTHER

Saline

Interventions

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Low-dose rhEpo

60IU/kg/week

Intervention Type DRUG

Micro-dose rhEpo

20IU/kg/week

Intervention Type DRUG

Placebo Control

Saline

Intervention Type OTHER

Other Intervention Names

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Recombinant Human Erythropoitin Recombinant Human Erythropoitin Saline

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Bispebjerg Hospital

OTHER

Sponsor Role lead

Responsible Party

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Soeren Lundgaard Larsen

Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Soeren L. Larsen

Role: PRINCIPAL_INVESTIGATOR

Bispebjerg Hospital

Locations

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Copenhagen University Hospital Bispebjerg, Department of Anaesthesiology

Copenhagen, Kbh NV, Denmark

Site Status

Countries

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Denmark

References

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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. eCollection 2012.

Reference Type BACKGROUND
PMID: 22419911 (View on PubMed)

Viuff SL, Plenge U, Belhage B, Boushel R, Koester T. Effects of low-dose recombinant human erythropoietin treatment on cognitive performance. Dan Med J. 2017 Sep;64(9):A5403.

Reference Type DERIVED
PMID: 28874242 (View on PubMed)

Other Identifiers

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H-1-2011-098

Identifier Type: -

Identifier Source: org_study_id

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