Response to Clenbuterol in Humans

NCT03860870 | Completed

• 1 other identifier: CLEN
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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..

Conditions

Healthy

Keywords

dried blood spots; skeletal muscle biopsies; muscle strength; muscle signaling

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Blood clenbuterol concentration

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

• Urine clenbuterol concentration

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

• Muscle strength

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

• Muscle signalling

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

• Plasma K+

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

Study Arms (2)

Clenbuterol

EXPERIMENTAL

Subjects ingest 80 micrograms of clenbuterol tablets

Drug: Clenbuterol Oral Product

Placebo

PLACEBO COMPARATOR

Subjects ingest placebo tablets

Drug: Placebo

Interventions

Clenbuterol Oral Product DRUG

Subjects ingest 4x20 microgram clenbuterol tablets

Clenbuterol

Placebo DRUG

Subjects ingest placebo tablets

Placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy
• Male
• years of age
• No known contraindications for anabolic drugs (e.g. cancer)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Copenhagen: lead

Study Sites (1)

August Krogh Building

Copenhagen, Denmark

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: First phase - open label Second phase - double-blinded
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Two phases: First phase sequential Second phase crossover

Study Record Dates

• First Submitted: February 26, 2019
• First Posted: March 4, 2019
• Study Start: March 11, 2019
• Primary Completion: December 21, 2022
• Study Completion: December 21, 2022
• Last Updated: August 9, 2024

Record last verified: 2024-08

Locations

DK (1)