Response to Clenbuterol in Humans

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Drug: Clenbuterol Oral Product; Drug: Placebo

• Registration Number: NCT03860870
• Lead Sponsor: University of Copenhagen

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..

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-02-26
• Study First Submitted QC: 2019-02-28
• Study First Posted: 2019-03-04
• Study Start: 2019-03-11
• Primary Completion: 2022-12-21
• Study Completion: 2022-12-21
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-08
• Last Update Posted: 2024-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Clenbuterol	Clenbuterol Oral Product	Subjects ingest 80 micrograms of clenbuterol tablets
Placebo	Placebo	Subjects ingest placebo tablets

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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 mTOR signalling	Before (baseline) as well as 2.5 hours after administration of study drug	mTOR phosphorylation in vastus lateralis biopsies
Metabolic rate	Before (baseline) as well as 2.5 hours after administration of study drug	Respriatory exchange ratio of oxygen and CO2
Body composition	Before (baseline) and after two-week treatment of study drug	Lean and fat mass during a DXA-scan
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
Maximal voluntary strength	Before (baseline) and after two-week treatment of study drug	Maximal voluntary isometric muscle strength of the quadriceps
Aerobic capacity	Before (baseline) and after two-week treatment of study drug	Maximal oxygen uptake during maximal exercise

Trial Locations

Locations (1)

August Krogh Building; 🇩🇰 Copenhagen, Denmark