Muscle Memory After Treatment With Anabolic Substance Clenbuterol and Resistance Training in Humans

Sponsor

Morten Hostrup, PhD (Other)

Overall Status

Recruiting

CT.gov ID

NCT05692856

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Skeletal Muscle Physiology	Drug: Clenbuterol Drug: Placebo	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Basic Science

Official Title:

Muscle Memory After Treatment With Anabolic Substance Clenbuterol and Resistance Training in Humans: Myonuclear Addition, Hypertrophy and Myocellular Reprogramming

Anticipated Study Start Date :

Feb 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2024

Anticipated Study Completion Date :

Aug 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Clenbuterol Participants are randomized to daily ingestion of clenbuterol for a period of 8 weeks, with or without supervised resistance training.	Drug: Clenbuterol 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.
Placebo Comparator: Placebo Participants are randomized to daily ingestion of placebo for a period of 8 weeks, with or without supervised resistance training.	Drug: Placebo 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.

Arm

Intervention/Treatment

Experimental: Clenbuterol

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

Drug: Clenbuterol

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.

Placebo Comparator: Placebo

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

Drug: Placebo

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.

Outcome Measures

Primary Outcome Measures

Fiber cross-sectional area [The change in fiber cross-sectional is assessed at baseline, 8, 24 and 32 weeks]
Immunohistochemistry to determine fiber cross-sectional area
Myonuclei [The change in myonuclei is assessed at baseline, 8, 24 and 32 weeks]
Immunohistochemistry to determine number of myonuclei
Skeletal muscle proteome [The change in the muscle proteome is assessed at baseline, 8, 24 and 32 weeks]
Pathway enrichment analysis of the muscle proteome using mass-spectrometry based proteomics

Secondary Outcome Measures

Lean mass [The change in lean mass is assessed at baseline, 8, 24 and 32 weeks]
Lean mass assessed by dual X-ray absorptiometry (DXA)
Isometric muscle strength [The change in maximal voluntary isometric contraction is assessed at baseline, 8, 24 and 32 weeks]
Maximal voluntary isometric contraction of m. quadriceps
Dynamic muscle strength [The change in 1-repetition maximum is assessed at baseline, 8, 24 and 32 weeks]
1-repetition maximum
Sprint performance [The change in sprint performance is assessed at baseline, 8, 24 and 32 weeks]
Work performed (W) during a sprint on a bicycle ergometer
Satellite cells [The change in satellite cells is assessed at baseline, 8, 24 and 32 weeks]
Immunohistochemistry to determine number of satellite cells

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	August Krogh Building	Copenhagen		Denmark	2100

Sponsors and Collaborators

Morten Hostrup, PhD

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Morten Hostrup, PhD, Associate Professor, University of Copenhagen

ClinicalTrials.gov Identifier:

NCT05692856

Other Study ID Numbers:

CLEN-MEM

First Posted:

Jan 20, 2023

Last Update Posted:

Jan 20, 2023

Last Verified:

Jan 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Clenbuterol

Study Results

No Results Posted as of Jan 20, 2023