Response to Clenbuterol in Humans

Study Overview
=================
Brief Summary
-----------------
Due to the long half-life ( 36 hr) of clenbuterol, detection methods such as dried blood spots (DBS) are a potentially suitable method to easily and non-invasively detect doping misuse of this compound for several days after ingestion. If, and how long, the compound can be detected by DBS has not yet been investigated but is of interest due to its potential in doping-control. The aim is to evaluate whether abuse of clenbuterol can be detected at relevant concentration levels in samples obtained using DBS and to assess the physiological response to clenbuterol in skeletal muscle..

Official Title
-----------------
Detectability of Clenbuterol and Physiological Response in Human Skeletal Muscle

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: Clenbuterol Oral Product
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Male 18-40 years of age No known contraindications for anabolic drugs (e.g. cancer) Exclusion Criteria: Abnormal ECG Steroid abuse Ongoing use of prescription medication heavy resistance training more than 2 times weekly Disease deemed by the MD to infer a risk to participate in the trial

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Two phases: First phase sequential Second phase crossover
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Clenbuterol<br>Subjects ingest 80 micrograms of clenbuterol tablets | Drug: Clenbuterol Oral Product<br>* Subjects ingest 4x20 microgram clenbuterol tablets<br>|
| Placebo Comparator: Placebo<br>Subjects ingest placebo tablets | Drug: Placebo<br>* Subjects ingest placebo tablets<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood clenbuterol concentration | Concentration of clenbuterol in dried blood spots | Before (baseline) as well as 3, 8, 24, 72, 168 and 240 hours after administration of clenbuterol | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood clenbuterol concentration | Concentration of clenbuterol in venous blood | Before (baseline) as well as 3, 8, 24, 72, 168 and 240 hours after administration of study drug | 
| Urine clenbuterol concentration | Concentration of clenbuterol in urine | Before (baseline) as well as 3, 8, 24, 72, 168 and 240 hours after administration of study drug | 
| Muscle strength | Maximal voluntary isometric contraction in N/m2 of the quadriceps | Before (baseline) and 2.5 hours after administration of study drug | 
| Muscle signalling | Protein kinase A phosphorylation in vastus lateralis biopsies | Before (baseline) and 2.5 hours after administration of study drug | 
| Plasma K+ | Venous plasma K+ concentration | Before (baseline) as well as 2.5 hours after administration of study drug | 
| Muscle mTOR signalling | mTOR phosphorylation in vastus lateralis biopsies | Before (baseline) as well as 2.5 hours after administration of study drug | 
| Metabolic rate | Respriatory exchange ratio of oxygen and CO2 | Before (baseline) as well as 2.5 hours after administration of study drug | 
| Maximal voluntary strength | Maximal voluntary isometric muscle strength of the quadriceps | Before (baseline) and after two-week treatment of study drug | 
| Body composition | Lean and fat mass during a DXA-scan | Before (baseline) and after two-week treatment of study drug | 
| Aerobic capacity | Maximal oxygen uptake during maximal exercise | Before (baseline) and after two-week treatment of study drug | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
dried blood spots, skeletal muscle biopsies, muscle strength, muscle signaling