Beta2-adrenergic Agonism and Muscle Remodelling
Overview
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
Full Title of Study: “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”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Basic Science
- Masking: Triple (Participant, Investigator, Outcomes Assessor)
- Study Primary Completion Date: May 30, 2021
Interventions
- Drug: Formoterol
- Subjects are treated with daily inhalation of formoterol
- Drug: Terbutaline
- Subjects are treated with daily inhalation of terbutaline
- Other: Placebo
- Subjects are treated with placebo
Arms, Groups and Cohorts
- Placebo Comparator: Control
- Subjects receive placebo treatment
- Experimental: Long acting beta2-agonist
- Subjects are treated with long-acting beta2-agonist formoterol
- Experimental: Short acting beta2-agonist
- Subjects are treated with short-acting beta2-agonist terbutaline
Clinical Trial Outcome Measures
Primary Measures
- Proteome enrichment
- Time Frame: Baseline and 6 weeks
- Change in enrichment (measured in muscle biopsies and assessed using GO annotations)
Secondary Measures
- Body composition
- Time Frame: Baseline, 2 weeks, 4 weeks and 6 weeks
- Change in body composition (measured by dual energy x ray absorptiometry)
- Maximal oxygen consumption (VO2max)
- Time Frame: Baseline, 2 weeks, 4 weeks and 6 weeks
- Change in VO2max (measured during bike ergometer cycling to exhaustion)
Participating in This Clinical Trial
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
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: 45 Years
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
Investigator Details
- Lead Sponsor
- Morten Hostrup, PhD
- Provider of Information About this Clinical Study
- Sponsor-Investigator: Morten Hostrup, PhD, Associate Professor – University of Copenhagen
Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.