Beta2-adrenergic Agonism and Muscle Remodelling

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Hypertrophy, Physiologic Hypertrophy, Physical Activity

Intervention / Treatment
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* Drug: Formoterol
* Drug: Terbutaline
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

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

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control<br>Subjects receive placebo treatment | Other: Placebo<br>* Subjects are treated with placebo<br>|
| Experimental: Long acting beta2-agonist<br>Subjects are treated with long-acting beta2-agonist formoterol | Drug: Formoterol<br>* Subjects are treated with daily inhalation of formoterol<br>|
| Experimental: Short acting beta2-agonist<br>Subjects are treated with short-acting beta2-agonist terbutaline | Drug: Terbutaline<br>* Subjects are treated with daily inhalation of terbutaline<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proteome enrichment | Change in enrichment (measured in muscle biopsies and assessed using GO annotations) | Baseline and 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body composition | Change in body composition (measured by dual energy x ray absorptiometry) | Baseline, 2 weeks, 4 weeks and 6 weeks | 
| Maximal oxygen consumption (VO2max) | Change in VO2max (measured during bike ergometer cycling to exhaustion) | Baseline, 2 weeks, 4 weeks and 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Proteome, VO2max, Muscle function, Exercise performance, Skeletal muscle, Doping, Anti-Doping, Enantiomeric analysis