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

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

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

Study Overview

• Status: Recruiting
• Conditions: Skeletal Muscle Physiology
• Intervention / Treatment: Drug: Clenbuterol; Drug: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Morten Hostrup; Phone Number: +4535321595; Email: mhostrup@nexs.ku.dk

Study Locations

• Denmark
  • Copenhagen, Denmark, 2100
    • Recruiting
    • August Krogh Building
    • Contact: Morten Hostrup; Phone Number: +4535321595; Email: mhostrup@nexs.ku.dk
    • Sub-Investigator: Lukas Moesgaard, MSc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Morten Hostrup, PhD

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2023
• Primary Completion (Anticipated): December 1, 2024
• Study Completion (Anticipated): August 1, 2025

Study Registration Dates

• First Submitted: December 23, 2022
• First Submitted That Met QC Criteria: January 19, 2023
• First Posted (Actual): January 20, 2023

Study Record Updates

• Last Update Posted (Actual): January 20, 2023
• Last Update Submitted That Met QC Criteria: January 19, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Adrenergic Agonists; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Adrenergic beta-Agonists; Sympathomimetics; Clenbuterol
• Other Study ID Numbers: CLEN-MEM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No