Clinical trial

Plasma and Exosome Proteomic Changes Associated With Augmented Erythropoiesis and Muscle Contractions.

Name

H-18013069

Description

Recombinant human erythropoietin (rHuEPO) regimen enhances maximal oxygen consumption (VO2max), but the effect of micro-doses on maximal and submaximal performance is not clear and detection of micro-doses is difficult with current methods. This study investigated whether micro-doses of rHuEPO enhances maximal and endurance performance in males and females.

Trial arms

Trial start

2019-08-28

Estimated PCD

2021-05-17

Trial end

2024-01-01

Status

Active (not recruiting)

Treatment

EPO

Please refer to the arm description

Arms:

Recombinant human erythropoietin treatment

Control group - saline injection

Please refer to the arm description

Arms:

Control group

Size

Primary endpoint

Change in maximal oxygen uptake

Change from baseline to 5 days after last injection

Change in time trial performance

Change from baseline to 3 days after last injection

Change in total hemoglobin mass

Change from baseline to 3 days after last injection

Eligibility criteria

Inclusion Criteria: * Relative maximum oxygen uptake (VO2-max) of at least 50 ml O2/min/kg for male participants and 45 ml O2/min/kg for female participants Exclusion Criteria: * Age * Insufficient fitness level * Blood donation 3 months prior to enrollment * Altitude exposure 2 months before enrollment * Hypertension

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Explorative', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'An algorithm was created using randomizer.org', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 48, 'type': 'ACTUAL'}}

Updated at

2023-11-29

1 organization

1 product

1 indication

Organization

University of Copenhagen

Product

EPO

Indication

Substance Use Disorder