Testosterone-induced Muscle Memory and Underlying Mechanisms

December 18, 2023 updated by: Morten Hostrup, PhD

Long-term Effects of Anabolic Androgenic Steroids on Muscle Growth Potential: Testosterone-induced Muscle Memory and Underlying Mechanisms

The purpose of this project is to investigate underlying mechanisms of testosterone- and resistance training-induced muscle hypertrophy and muscle memory in humans.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Lukas Moesgaard
  • Phone Number: +4561724440
  • Email: lm@nexs.ku.dk

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Testosterone
Participants are randomized to a single injection of 1000 mg testosterone undecanoate
Drug: Testosterone Undecanoate
Following testosterone/placebo injection, participants undergo supervised resistance training for 4 weeks. This period is followed by a washout of 16 weeks with no drug and resistance training. Thereafter, another 4-week period with supervised resistance training is commenced, with no drug.
Placebo Comparator: Placebo
Participants are randomized to a single placebo injection
Drug: Testosterone Undecanoate
Following testosterone/placebo injection, participants undergo supervised resistance training for 4 weeks. This period is followed by a washout of 16 weeks with no drug and resistance training. Thereafter, another 4-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
Time Frame: The change in fiber cross-sectional is assessed at baseline, 4, 20 and 24 weeks
Immunohistochemistry to determine fiber cross-sectional area
The change in fiber cross-sectional is assessed at baseline, 4, 20 and 24 weeks
Myonuclei
Time Frame: The change in myonuclei is assessed at baseline, 4, 20 and 24 weeks
Immunohistochemistry to determine number of myonuclei
The change in myonuclei is assessed at baseline, 4, 20 and 24 weeks
Skeletal muscle proteome
Time Frame: The change in the muscle proteome is assessed at baseline, 4, 20 and 24 weeks
Pathway enrichment analysis of the muscle proteome using mass spectrometry-based proteomics
The change in the muscle proteome is assessed at baseline, 4, 20 and 24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lean mass
Time Frame: The change in lean mass is assessed at baseline, 4, 20 and 24 weeks
Lean mass assessed by dual X-ray absorptiometry (DXA)
The change in lean mass is assessed at baseline, 4, 20 and 24 weeks
Satellite cells
Time Frame: The change in satellite cells is assessed at baseline, 4, 20 and 24 weeks
Immunohistochemistry to determine number of satellite cells
The change in satellite cells is assessed at baseline, 4, 20 and 24 weeks
Muscle strength
Time Frame: The change in 1-repetition maximum is assessed at baseline, 4, 20 and 24 weeks
1-repetition maximum
The change in 1-repetition maximum is assessed at baseline, 4, 20 and 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Morten Hostrup, PhD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2024

Primary Completion (Estimated)

September 1, 2025

Study Completion (Estimated)

September 1, 2025

Study Registration Dates

First Submitted

December 18, 2023

First Submitted That Met QC Criteria

December 18, 2023

First Posted (Estimated)

January 3, 2024

Study Record Updates

Last Update Posted (Estimated)

January 3, 2024

Last Update Submitted That Met QC Criteria

December 18, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TESTO

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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