NCT05692856

Brief Summary

The purpose of the project is investigate muscle memory and underlying mechanisms in humans following resistance training and use of the anabolic substance clenbuterol.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 23, 2022

Completed
28 days until next milestone

First Posted

Study publicly available on registry

January 20, 2023

Completed
12 days until next milestone

Study Start

First participant enrolled

February 1, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

January 20, 2023

Status Verified

January 1, 2023

Enrollment Period

1.8 years

First QC Date

December 23, 2022

Last Update Submit

January 19, 2023

Conditions

Outcome Measures

Primary Outcomes (3)

  • Fiber cross-sectional area

    Immunohistochemistry to determine fiber cross-sectional area

    The change in fiber cross-sectional is assessed at baseline, 8, 24 and 32 weeks

  • Myonuclei

    Immunohistochemistry to determine number of myonuclei

    The change in myonuclei is assessed at baseline, 8, 24 and 32 weeks

  • Skeletal muscle proteome

    Pathway enrichment analysis of the muscle proteome using mass-spectrometry based proteomics

    The change in the muscle proteome is assessed at baseline, 8, 24 and 32 weeks

Secondary Outcomes (5)

  • Lean mass

    The change in lean mass is assessed at baseline, 8, 24 and 32 weeks

  • Isometric muscle strength

    The change in maximal voluntary isometric contraction is assessed at baseline, 8, 24 and 32 weeks

  • Dynamic muscle strength

    The change in 1-repetition maximum is assessed at baseline, 8, 24 and 32 weeks

  • Sprint performance

    The change in sprint performance is assessed at baseline, 8, 24 and 32 weeks

  • Satellite cells

    The change in satellite cells is assessed at baseline, 8, 24 and 32 weeks

Study Arms (2)

Clenbuterol

EXPERIMENTAL

Participants are randomized to daily ingestion of clenbuterol for a period of 8 weeks, with or without supervised resistance training.

Drug: Clenbuterol

Placebo

PLACEBO COMPARATOR

Participants are randomized to daily ingestion of placebo for a period of 8 weeks, with or without supervised resistance training.

Drug: Placebo

Interventions

Participants ingest 80 micrograms clenbuterol daily during the initial 8-week period. This period is followed by a washout of 16 weeks with no drug and resistance training. Thereafter, an 8-week period with supervised resistance training is commenced, with no drug.

Clenbuterol

Participants ingest placebo tablets daily during the initial 8-week period. This period is followed by a washout of 16 weeks with no drug and resistance training. Thereafter, an 8-week period with supervised resistance training is commenced, with no drug.

Placebo

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy men and women
  • BMI of \<26 and normal ECG and blood pressure

You may not qualify if:

  • Smoking
  • Chronic disease,
  • Use of prescription medication
  • Pain due to current or previous musculoskeletal injury
  • Resistance training more than once per week in the 12 months leading up to the intervention
  • Current or previous use of prohibited anabolic substances

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

August Krogh Building

Copenhagen, 2100, Denmark

RECRUITING

MeSH Terms

Interventions

Clenbuterol

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAmines

Central Study Contacts

Morten Hostrup

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 23, 2022

First Posted

January 20, 2023

Study Start

February 1, 2023

Primary Completion

December 1, 2024

Study Completion

August 1, 2025

Last Updated

January 20, 2023

Record last verified: 2023-01

Locations