Response to Clenbuterol in Humans

Healthy Clinical Trial

Official title:

Detectability of Clenbuterol and Physiological Response in Human Skeletal Muscle

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03860870
• Other study ID #: CLEN
• Status: Recruiting
• Phase: N/A
• Start date: March 11, 2019
• Est. completion date: March 15, 2022

Study information

• Verified date: April 2021
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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..

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 16
• Est. completion date: March 15, 2022
• Est. primary completion date: March 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Clenbuterol Oral Product
Subjects ingest 4x20 microgram clenbuterol tablets
• Placebo
Subjects ingest placebo tablets

Locations

Country	Name	City	State
Denmark	August Krogh Building	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Muscle strength	Maximal voluntary isometric contraction in N/m2 of the quadriceps	Before (baseline) and 2.5 hours after administration of study drug
Secondary	Muscle signalling	Protein kinase A phosphorylation in vastus lateralis biopsies	Before (baseline) and 2.5 hours after administration of study drug
Secondary	Plasma K+	Venous plasma K+ concentration	Before (baseline) as well as 2.5 hours after administration of study drug
Secondary	Muscle mTOR signalling	mTOR phosphorylation in vastus lateralis biopsies	Before (baseline) as well as 2.5 hours after administration of study drug
Secondary	Metabolic rate	Respriatory exchange ratio of oxygen and CO2	Before (baseline) as well as 2.5 hours after administration of study drug
Secondary	Maximal voluntary strength	Maximal voluntary isometric muscle strength of the quadriceps	Before (baseline) and after two-week treatment of study drug
Secondary	Body composition	Lean and fat mass during a DXA-scan	Before (baseline) and after two-week treatment of study drug
Secondary	Aerobic capacity	Maximal oxygen uptake during maximal exercise	Before (baseline) and after two-week treatment of study drug