Response to Clenbuterol in Humans

NCT ID: NCT03860870

Last Updated: 2024-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-11

Study Completion Date

2022-12-21

Brief Summary

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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

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Two phases:

First phase sequential Second phase crossover
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
First phase - open label Second phase - double-blinded

Study Groups

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Clenbuterol

Subjects ingest 80 micrograms of clenbuterol tablets

Group Type EXPERIMENTAL

Clenbuterol Oral Product

Intervention Type DRUG

Subjects ingest 4x20 microgram clenbuterol tablets

Placebo

Subjects ingest placebo tablets

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Subjects ingest placebo tablets

Interventions

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Clenbuterol Oral Product

Subjects ingest 4x20 microgram clenbuterol tablets

Intervention Type DRUG

Placebo

Subjects ingest placebo tablets

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Copenhagen

OTHER

Sponsor Role lead

Responsible Party

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Morten Hostrup, PhD

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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August Krogh Building

Copenhagen, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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CLEN

Identifier Type: -

Identifier Source: org_study_id

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