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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06188767
Other study ID # TESTO
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date September 1, 2024
Est. completion date September 1, 2025

Study information

Verified date December 2023
Source University of Copenhagen
Contact Lukas Moesgaard
Phone +4561724440
Email lm@nexs.ku.dk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 30
Est. completion date September 1, 2025
Est. primary completion date September 1, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 40 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Morten Hostrup, PhD

Outcome

Type Measure Description Time frame Safety issue
Primary Fiber cross-sectional area Immunohistochemistry to determine fiber cross-sectional area The change in fiber cross-sectional is assessed at baseline, 4, 20 and 24 weeks
Primary Myonuclei Immunohistochemistry to determine number of myonuclei The change in myonuclei is assessed at baseline, 4, 20 and 24 weeks
Primary 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, 4, 20 and 24 weeks
Secondary Lean mass Lean mass assessed by dual X-ray absorptiometry (DXA) The change in lean mass is assessed at baseline, 4, 20 and 24 weeks
Secondary Satellite cells Immunohistochemistry to determine number of satellite cells The change in satellite cells is assessed at baseline, 4, 20 and 24 weeks
Secondary Muscle strength 1-repetition maximum The change in 1-repetition maximum is assessed at baseline, 4, 20 and 24 weeks
See also
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Recruiting NCT05692856 - Muscle Memory After Treatment With Anabolic Substance Clenbuterol and Resistance Training in Humans N/A