Physical Activity Clinical Trial
Official title:
Gender-specific Role of the beta2-adrenergic Stimulation With Short- or Long-acting Selective Agonist in Relation to Muscle Remodelling, Function, Performance, and Anti-doping
NCT number | NCT03565302 |
Other study ID # | FOR/TER |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | June 25, 2018 |
Est. completion date | May 30, 2021 |
Verified date | March 2020 |
Source | University of Copenhagen |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The study aims to investigate gender-specific adaptations to beta2-adrenoceptor stimulation with selective short- and long-acting beta2-agonist with emphasis on skeletal muscle in relation to performance enhancing effects and anti-doping
Status | Recruiting |
Enrollment | 72 |
Est. completion date | May 30, 2021 |
Est. primary completion date | May 30, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 45 Years |
Eligibility |
Inclusion Criteria: - Healthy men and women, aged 18-45 years - VO2max >55 ml/kg/min for men and >50 ml/kg/min for women (± biologic and techinical variation of 5.6% (Katch et al. 1982) - Body Mass Index (BMI) < 26 Exclusion Criteria: - Chronic user of beta2-agonist or allergy towards study drugs - Serious adverse side effects of the used study drug - Chronic disease that by the project physician would affect any of the outcomes of the study - Smoker - Chronic use of prescription medication (other than contraceptives for women) - Pregnancy |
Country | Name | City | State |
---|---|---|---|
Denmark | August Krogh Building | Copenhagen |
Lead Sponsor | Collaborator |
---|---|
Morten Hostrup, PhD |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Drug exposure | Measured in urine using enantiomeric analysis | Day 1-14 and day 49-56 | |
Primary | Proteome enrichment | Change in enrichment (measured in muscle biopsies and assessed using GO annotations) | Baseline and 6 weeks | |
Secondary | Body composition | Change in body composition (measured by dual energy x ray absorptiometry) | Baseline, 2 weeks, 4 weeks and 6 weeks | |
Secondary | Maximal oxygen consumption (VO2max) | Change in VO2max (measured during bike ergometer cycling to exhaustion) | Baseline, 2 weeks, 4 weeks and 6 weeks |
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