The Effect of Micro-doses Erytropoietin on Exercise Capacity in Male and Females

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
In a randomized, double-blind, placebo-controlled design, 48 trained adults (24 females, 24 males) receive either recombinant human erythropoietin (rHuEPO; epoetin-β, 9 IU/kg, n = 24, (12 females, 12 males)) or placebo (0,9% NaCl, n = 24, (12 females, 12 males)) three times per week for four weeks. Before the intervention, time trial performance and maximal oxygen uptake will be assessed. Three and five days after the last injection, time trial performance and maximal oxygen uptake will be determined to assess the effect of the rHuEPO administration. In addition, total hemoglobin mass and intravascular volumes will be determined via the carbon monoxide rebreathing method in duplicate measures.

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

Conditions
-----------------
Sports Drug Abuse

Intervention / Treatment
-----------------
* Drug: EPO
* Other: Control group - saline injection


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Explorative
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Recombinant human erythropoietin treatment<br>Participants receive intravenous injections of 9 International Units per kg bodyweight epoetin-β (NeoRecormon, Roche, Mannheim, Germany) three times per week for four weeks on non-consecutive days. Subjects receive tablets with 80mg iron (Tardyferon, Pierre Fabre Pharme GmbH, Freiburg, Germany) to ensure sufficient iron stores for the expected increase in erythropoeisis. | Drug: EPO<br>* Please refer to the arm description<br>|
| Placebo Comparator: Control group<br>Participants receive intravenous injections of  0,5 mL saline (NaCl 0,9%) three times per week for four weeks on non-consecutive days. | Other: Control group - saline injection<br>* Please refer to the arm description<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in maximal oxygen uptake | Change from baseline maximal aerobic capacity 5 days after last injection. Measured via an exhaustive incremental cycle ergometer test. | Change from baseline to 5 days after last injection | 
| Change in time trial performance | Change from baseline endurance exercise performance 3 days after last injection. Measured via a preloaded 400 kcal time-trial. | Change from baseline to 3 days after last injection | 
| Change in total hemoglobin mass | Change from baseline total hemoglobin mass 3 days after last injection. Measured by the carbon monoxide rebreathing method. | Change from baseline to 3 days after last injection | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
erythropoeitin, doping