- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04136457
Proteome Remodelling
December 19, 2023 updated by: Morten Hostrup, PhD
Proteome Remodelling and Dynamics in Human Skeletal Muscle: Effect of Training
The purpose of the project is to investigate the proteome signature dynamics and remodelling in human skeletal muscle induced by exercise training
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
72
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 Locations
-
-
-
Copenhagen, Denmark
- August Krogh Building
-
-
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
18 years to 45 years (Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Healthy men and women
- VO2max > 55 mL/min/kgLM for men and > 50 for women (only applicable for endurance and sprint training interventions)
- BMI < 26
Exclusion Criteria:
- Chronic disease deemed by the medical doctor to pose a risk or to affect study outcomes
- smoking
- Use of prescription medicine deemed by the medical to affect study outcomes
- Pregnancy
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: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Endurance
Endurance training
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Subjects perform a period of endurance training
|
|
Experimental: Resistance
Resistance training
|
Subjects perform a period of resistance training
|
|
Experimental: Sprint
Sprint training
|
Subjects perform a period of sprint training
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Skeletal muscle proteome signature
Time Frame: Change from baseline at week 6 or 8 depending on the intervention
|
Pathway enrichment analysis of the muscle proteome
|
Change from baseline at week 6 or 8 depending on the intervention
|
|
Anabolic signaling
Time Frame: Change in anabolic signaling from rest to 1 hour following resistance exercise both at baseline and following 8 weeks of resistance training
|
Western blotting of proteins related to anabolic signaling
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Change in anabolic signaling from rest to 1 hour following resistance exercise both at baseline and following 8 weeks of resistance training
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Skeletal muscle mitochondrial respiration
Time Frame: Change from baseline at week 6 following endurance and sprint training
|
High resolution respirometry
|
Change from baseline at week 6 following endurance and sprint training
|
|
Maximal oxygen consumption
Time Frame: Change from baseline at week 6 following endurance and sprint training
|
VO2max during incremental exercise
|
Change from baseline at week 6 following endurance and sprint training
|
|
Body composition
Time Frame: Change from baseline at week 6 or 8 depending on the intervention
|
Lean and fat mass during dual X-ray absorptiometry
|
Change from baseline at week 6 or 8 depending on the intervention
|
|
Myonuclei
Time Frame: Change from baseline at week 8 following resistance training
|
Immunohistochemistry to determine number of myonuclei
|
Change from baseline at week 8 following resistance training
|
|
Satellite cells
Time Frame: Change from baseline at week 8 following resistance training
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Immunohistochemistry to determine number of satellite cells
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Change from baseline at week 8 following resistance training
|
|
Fiber size
Time Frame: Change from baseline at week 8 following resistance training
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Immunohistochemistry to determine fiber size
|
Change from baseline at week 8 following resistance training
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Skeletal muscle mitochondrial supercomplexes
Time Frame: Change from baseline at week 6 following endurance and sprint training
|
Pathway enrichment analysis of mitochondrial supercomplexes
|
Change from baseline at week 6 following endurance and sprint training
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (Actual)
October 30, 2019
Primary Completion (Actual)
November 28, 2023
Study Completion (Actual)
November 28, 2023
Study Registration Dates
First Submitted
October 21, 2019
First Submitted That Met QC Criteria
October 21, 2019
First Posted (Actual)
October 23, 2019
Study Record Updates
Last Update Posted (Actual)
December 27, 2023
Last Update Submitted That Met QC Criteria
December 19, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- MiDy
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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