Healthy
Conditions
Brief summary
Blood donations is a essential and crucial in the clinic. Normal biological variation of relevant biomarkers and hormones before the donation of 450 mL whole blood as well as the expected alterations in systemic levels of plasma iron indices and RBC measures up to 4 weeks after donation in healthy, non-anemic, young men and women is investigated Likewise, the possibilities for detecting autologous blood transfusion is investigated.
Detailed description
Blood donations is a essential and crucial in the clinic. A whole blood donation results in the loss of 450-525 mL whole blood in eight to ten minutes and is known to reduce body iron stores with 200-265 mg iron depending on the donor's age, hematocrit and sex and accounts for 25% of average tissue iron stores in men and up to 75% in women.In the present study, the investigators aimed at thoroughly evaluate normal biological variation of relevant biomarkers and hormones before the donation of 450 mL whole blood as well as the expected alterations in systemic levels of plasma iron indices and red blood cell measures up to 4 weeks after donation in healthy, non-anemic, young men and women Likewise, doping in sport is a major problem concerning both the health of the athletes and the integrity of sports. Despite major improvements in anti-doping work in recent years, it is still impossible to test for all existing and future doping strategies, such as manipulation with blood oxygen carrying capacity. A well-known doping strategy is autologous blood transfusion (ABT), and at present, the detection of ABT is a challenge for anti-doping authorities. The hypotheses for this study are that 1) ret% and abnormal blood profile score (ABPS) have higher sensitivity to micro-dose ABT compared to current variables in the Athlete Biological Passport (ABP); 2) The plasma concentration of hepcidin and erythroferrone (ERFE) is sensitive to micro-dose ABT; 3) Gender-specific variations in hematologic variables affect the interpretation of the athlete's biological passport.
Interventions
PROCEDUREBlood donation and blood transfusion
24 subjects (12 female, 12 male) is phlebotomized and four weeks later \ 130 mL packed red blood cells are re-infused in the same subjects.
Sponsors
University of Copenhagen
World Anti-Doping Agency
University of California, Los Angeles
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
An algorithm was created using randomizer.org
Intervention model description
Explorative
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Relative maximum oxygen uptake (VO2-max) of at least 55 ml O2/min/kg for male participants and 50 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobin centration | 6 days after reinfusion | The effect of the intervention on \[Hb\] levels will be investigated |
| reticulocyte percentage | 6 days after reinfusion | The effect of the intervention on ret% levels will be investigated |
| OFF-score | 6 days after reinfusion | The effect of the intervention on OFF-score (an algorithm computed from reticulocyte percentage and hemoglobin concentration resulting in a arbitrary value) will be investigated |
| Homeostatic markers of iron metabolism | 6 days after reinfusion | Markers of iron metabolism such as hepcidin and erythroferrone are collected and analyzed for evaluation of iron metabolism during and after donation and reinfusion of blood. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean corpuscular volume | 6 days after reinfusion. | Markers of red blood cell size and hemoglobin content are collected and analyzed for Determining the impact of donation and reinfusion of blood. |
| Endurance exercise performance measured as a preloaded 400 kcal time-trial | 6 days after reinfusion. | Endurance exercise performance are measured in a subgroup of 13 subjects. |
| Dried Blood Spots | 6 days after reinfusion. | Dried blood spots will be analyzed for the CD71/Band3 concentration as well as transcriptomic markers for reticolucytes including the ALAS2 L and LC. |
| Maximal oxugen uptake (VO2max) | 6 days after reinfusion. | Maximal aerobic capacity is measured via a maximal oxygen uptake incremental test in a subgroup of 13 subjects. |
| Mean corpuscular concentration | 6 days after reinfusion. | Markers of red blood cell size and hemoglobin content are collected and analyzed for Determining the impact of donation and reinfusion of blood. |
| Mean corpuscular hemoglobin concentration | 6 days after reinfusion. | Markers of red blood cell size and hemoglobin content are collected and analyzed for Determining the impact of donation and reinfusion of blood. |
Countries
Denmark
Outcome results
None listed