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Completed

NCT Number: NCT03860870

Response to Clenbuterol in Humans

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..

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Key information

Conditions

Healthy

Age range

18 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

August Krogh Building

Copenhagen, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Clenbuterol Oral Product

Drug

Subjects ingest 4x20 microgram clenbuterol tablets

Placebo

Drug

Subjects ingest placebo tablets

Primary outcomes

  1. Blood clenbuterol concentration

    Time frame: 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 outcomes

  1. Blood clenbuterol concentration

    Time frame: Before (baseline) as well as 3, 8, 24, 72, 168 and 240 hours after administration of study drug

    Concentration of clenbuterol in venous blood

  2. Urine clenbuterol concentration

    Time frame: Before (baseline) as well as 3, 8, 24, 72, 168 and 240 hours after administration of study drug

    Concentration of clenbuterol in urine

  3. Muscle strength

    Time frame: Before (baseline) and 2.5 hours after administration of study drug

    Maximal voluntary isometric contraction in N/m2 of the quadriceps

  4. Muscle signalling

    Time frame: Before (baseline) and 2.5 hours after administration of study drug

    Protein kinase A phosphorylation in vastus lateralis biopsies

  5. Plasma K+

    Time frame: Before (baseline) as well as 2.5 hours after administration of study drug

    Venous plasma K+ concentration

  6. Muscle mTOR signalling

    Time frame: Before (baseline) as well as 2.5 hours after administration of study drug

    mTOR phosphorylation in vastus lateralis biopsies

  7. Metabolic rate

    Time frame: Before (baseline) as well as 2.5 hours after administration of study drug

    Respriatory exchange ratio of oxygen and CO2

  8. Maximal voluntary strength

    Time frame: Before (baseline) and after two-week treatment of study drug

    Maximal voluntary isometric muscle strength of the quadriceps

  9. Body composition

    Time frame: Before (baseline) and after two-week treatment of study drug

    Lean and fat mass during a DXA-scan

  10. Aerobic capacity

    Time frame: Before (baseline) and after two-week treatment of study drug

    Maximal oxygen uptake during maximal exercise

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Registry information

Official study title

Detectability of Clenbuterol and Physiological Response in Human Skeletal Muscle

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Mar 4, 2019
Registry last updated
Aug 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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