Healthy
Conditions
Keywords
dried blood spots, skeletal muscle biopsies, muscle strength, muscle signaling
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..
Interventions
DRUGClenbuterol Oral Product
Subjects ingest 4x20 microgram clenbuterol tablets
DRUGPlacebo
Subjects ingest placebo tablets
Sponsors
University of Copenhagen
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
First phase - open label Second phase - double-blinded
Intervention model description
Two phases: First phase sequential Second phase crossover
Eligibility
Sex/Gender
MALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood clenbuterol concentration | Before (baseline) as well as 3, 8, 24, 72, 168 and 240 hours after administration of clenbuterol | Concentration of clenbuterol in dried blood spots |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Urine clenbuterol concentration | Before (baseline) as well as 3, 8, 24, 72, 168 and 240 hours after administration of study drug | Concentration of clenbuterol in urine |
| Muscle strength | Before (baseline) and 2.5 hours after administration of study drug | Maximal voluntary isometric contraction in N/m2 of the quadriceps |
| Muscle signalling | Before (baseline) and 2.5 hours after administration of study drug | Protein kinase A phosphorylation in vastus lateralis biopsies |
| Plasma K+ | Before (baseline) as well as 2.5 hours after administration of study drug | Venous plasma K+ concentration |
| Blood clenbuterol concentration | Before (baseline) as well as 3, 8, 24, 72, 168 and 240 hours after administration of study drug | Concentration of clenbuterol in venous blood |
| Metabolic rate | Before (baseline) as well as 2.5 hours after administration of study drug | Respriatory exchange ratio of oxygen and CO2 |
| Maximal voluntary strength | Before (baseline) and after two-week treatment of study drug | Maximal voluntary isometric muscle strength of the quadriceps |
| Body composition | Before (baseline) and after two-week treatment of study drug | Lean and fat mass during a DXA-scan |
| Aerobic capacity | Before (baseline) and after two-week treatment of study drug | Maximal oxygen uptake during maximal exercise |
| Muscle mTOR signalling | Before (baseline) as well as 2.5 hours after administration of study drug | mTOR phosphorylation in vastus lateralis biopsies |
Countries
Denmark
Outcome results
None listed