Fietsprestatie Cycling performance slow cycling
Conditions
Interventions
Weekly subcutaneous doses of Neorecormon (5000 IU, or adjusted to reach the
desired Hemoglobin increase, maximum dose is 10.000 IU). Additionally, all
subject will receive Vitamin C and iron supplem
Sponsors
Centre for Human Drug Research
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Well-trained (as determined by cycling history and maximal power output >4 W/kg) male subjects, 18 to 50 years old (inclusive); 2. Subjects must be healthy / medically stable on the basis of clinical laboratory tests, medical history, vital signs, and 12-lead ECG performed at screening, including exercise ECG. 3. Each subject must sign an informed consent form prior to the study. This means the subject understands the purpose of and procedures required for the study.
Exclusion criteria
Exclusion criteria: 1. Any clinically significant abnormality, as determined by medical history taking and physical examinations, obtained during the screening visit that in the opinion of the investigator would interfere with the study objectives or compromise subject safety. 2. Unacceptable known concomitant diagnoses or diseases at baseline, e.g., known cardiovascular, pulmonary, muscle, metabolic or haematological disease, renal or liver dysfunction, ECG or laboratory abnormalities, etc. 3. Unacceptable concomitant medications at baseline, e.g., drugs known or likely to interact with the study drugs or study assessments. 4. Unacceptable potential cycling performance enhancing medications at baseline, e.g. Erythropoiesis-stimulating agents, Anabolic Androgenic Steroids, Growth Hormone, Insulin, IGF-I and Beta-Adrenergic Agents or methods, e.g. altitude tents. 5. Blood transfusion in the past three months. 6. Loss or donation of blood over 500 mL within three months. 7. Participation in a clinical trial within 90 days of screening or more than 4 times in the previous year. 8. Known hypersensitivity to the treatment or drugs of the same class, or any of their excipients. 9. Any known factor, condition, or disease that might interfere with treatment compliance, study conduct or interpretation of the results such as drug or alcohol dependence or psychiatric disease. 10. Positive urine drug test at screening 11. Positive alcohol breath test at screening 12. Haemoglobin (Hb) concentration > 9.8 mmol/l at screening. 13. Hb concentration
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Exercise tests All subjects will breathe during the exercise test through a facemask that will be connected to an oxymeter to collect inspired and expired gasses for analyzing: - Oxygen consumption, VO2 (L/min) - Carbon dioxide production, VCO2 (L/min) - Respiratory minute ventilation, VE (L/min) - Tidal volume, Vt (L) - Respiratory frequency, Rf - Maximal oxygen consumption, VO2,max (ml kg-1 min-1) During the exercise tests blood will be collected at predetermined stages to measure: - Lactate levels - Tissue plasminogen activator - Creatinine phosphokinase - C-reactive protein levels VO2 and VCO2 will be used to calculate: - Ventilatory equivalent for oxygen (VE/VO2), eqVO2 - Ventilatory equivalent for carbon dioxide (VE/VCO2), eqVCO2 these values will be used to determine: - Ventilatory threshold 1, VT1 - Ventilatory threshold 2, VT2 Physiological parameters that will be determined at VT1 and VT2: - Oxygen consumption, VO2 (L/min) - Oxygen consumption per kg, VO2 (L/min/kg) - Percentage of maximal oxygen consumption, %VO2max (L/min) - Power output, P (J/s) - Power output per kg, P (J/s/kg) Physiological parameters that will be determined at maximal effort: - Maximal oxygen consumption, VO2max (L/min) - Maximal oxygen consumption per kg, VO2max (L/min/kg) - Maximal power output, Pmax (J/s) - Maximal power output per kg, Pmax (J/s/kg) - Lactate values Other determinations: - Lactate threshold 1, LT1 - Lactate threshold 2, LT2 - Cycling economy, CE (W L-1 min-1) - Gross efficiency, GE (%) - Heart rate (bpm) - Systolic blood pressure (mmHg) - Diastolic blood pressure (mmHg) Competition Maximal and submaximal exercise parameters that will be measured and calculated during the competition: - Power (W) - Heart rate (bpm) - Systolic blood pressure (mmHg) - Diastolic blood pressure (mmHg) | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety markers: Monitoring vital signs o Pulse Rate (bpm) o Systolic blood pressure (mmHg) o Diastolic blood pressure (mmHg) o Temperature measurements (ºC) Electrocardiogram (ECG) o Heart Rate (HR) (bpm), PR, QRS, QT, QTcB, QTcF Clinical Laboratory Assessments o Haematology Ht must be | — |
Countries
Netherlands
Outcome results
None listed