Human VolunteersEarly Phase 1NCT03093506
Effects of Micro-dose and Low-dose Recombinant Human Erythropoietin on Mitochondrial Function and Cognitive Performance
A Early Phase 1 study testing Low-dose rhEpo and Micro-dose rhEpo in people with Human Volunteers, run by Bispebjerg Hospital at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Human Volunteers
- What is being tested?
- Low-dose rhEpo and Micro-dose rhEpo
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2011to Dec 2011
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Normal medical examination
- Weekly exercise for 0-5 hours
Who cannot join
- Smoking daily
- Earlier use of performance-enhancing drugs
- Elite athletes
- Presence of cardiovascular or metabolic disease
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Copenhagen University Hospital Bispebjerg, Department of Anaesthesiology
Copenhagen, Kbh NV, 2400
About this study
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.
Read the 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.
- Conditions
- Human Volunteers
- Being tested
- Low-dose rhEpo, Micro-dose rhEpo, Placebo Control
- Keywords
- Erythropoietin, Randomized controlled trial, Human volunteers, Mitochondrial function, Cognitive performance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-dose rhEpoDrug
Also called Recombinant Human Erythropoitin
60IU/kg/week
Micro-dose rhEpoDrug
Also called Recombinant Human Erythropoitin
20IU/kg/week
Placebo ControlOther
Also called Saline
Saline
| Study group | Role | What they receive |
|---|---|---|
| Low-dose rhEpo | Active comparator | RhEpo 60IU/kg/week Receives: Drug: Low-dose rhEpo |
| Micro-dose rhEpo | Active comparator | RhEpo 20IU/kg/week Receives: Drug: Micro-dose rhEpo |
| Placebo Control | Placebo comparator | Saline Receives: Other: Placebo Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal oxygen-flux (picomol/second)
Measured: Four weeks
Secondary outcomes (3)
Sum of speed-score and accuracy-score in the RAVEN-test
Measured: Four weeks
Number of correctly found fields in the NUFI-test
Measured: Four weeks
Rating of the interviews on a scale from -3 to +3 according to experienced change in ability to concentrate
Measured: Four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2017
- Study startSep 2011
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Human VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Soeren Lundgaard Larsen, Bispebjerg Hospital
- Investigators
- Soeren L. Larsen, Principal investigator, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03093506
- Sponsor's protocol ID
- H-1-2011-098
- Status last verified
- Mar 2017
- First submitted
- 8 Jan 2015
- Last updated
- 28 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22419911Viuff 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.
PubMed 28874242
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Micro-dose and Low-dose Recombinant Human Erythropoietin on Mitochondrial Function and Cognitive Performance
- ClinicalTrials.gov ID
- NCT03093506
- Acronym / sponsor ID
- H-1-2011-098
- Conditions
- Human Volunteers
- Keywords
- Erythropoietin, Randomized controlled trial, Human volunteers, Mitochondrial function, Cognitive performance
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 28 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low-dose rhEpo | Active comparator | Drug: Low-dose rhEpoRhEpo 60IU/kg/week |
| Micro-dose rhEpo | Active comparator | Drug: Micro-dose rhEpoRhEpo 20IU/kg/week |
| Placebo Control | Placebo comparator | Other: Placebo ControlSaline |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Normal medical examination
- Weekly exercise for 0-5 hours
Key exclusion criteria (4 listed)
- Smoking daily
- Earlier use of performance-enhancing drugs
- Elite athletes
- Presence of cardiovascular or metabolic disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low-dose rhEpoAlso: Recombinant Human Erythropoitin60IU/kg/week | Drug | Low-dose rhEpo |
| Micro-dose rhEpoAlso: Recombinant Human Erythropoitin20IU/kg/week | Drug | Micro-dose rhEpo |
| Placebo ControlAlso: SalineSaline | Other | Placebo Control |
Primary outcome
Maximal oxygen-flux (picomol/second)
Time frame: Four weeks
3 secondary outcomes
Sum of speed-score and accuracy-score in the RAVEN-test
Time frame: Four weeks
Number of correctly found fields in the NUFI-test
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2017.
- Background: PubMed 22419911Plenge 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.
- Derived from this study: PubMed 28874242Viuff 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Soeren L. Larsen principal investigator
Bispebjerg Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Low-dose rhEpo and Micro-dose rhEpo in people with Human Volunteers, run by Bispebjerg Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal oxygen-flux (picomol/second) (time frame: Four weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03093506, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2017.