HealthyNCT03270475
Effect of Exercise on Muscle Proteome Signature
A study testing exercise training in people with Healthy, run by Morten Hostrup, PhD at 1 site in Denmark.
Trial summary
The aim of the study is to investigate skeletal muscle proteome signature changes induced by exercise training in young men Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- exercise training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteDenmark
- Study dates
- 28 Aug 2017to 15 Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy
- VO2max of 45-55 ml/kg/min (+/- SD) / 3000-4000 ml/min (+/- SD)
- Body mass index (BMI) of 19-26 kg/m2
- Normal ECG (electrocardiography)
Who cannot join
- Serious adverse effects to exercise
- Chronic disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Exercise Training on Skeletal Muscle Proteome Signature of Young Men
The aim of the study is to investigate skeletal muscle proteome signature changes induced by exercise training in young men
Read the detailed description
Advances in omics technologies have allowed for the identification of biomarkers with importance for the beneficial adaptations imposed by exercise training. Skeletal muscle exhibits remarkable plasticity to exercise training, as illustrated by pronounced alterations to the proteomic landscape, such as mitochondrial biogenesis. However, despite recent advances that have helped describe the proteomic landscape in response to a period of exercise training, our understanding of the processes pertaining to post-translation modification is scant. In this study, we aim to investigate the human acetylome and proteome in response to exercise training.
- Conditions
- Healthy
- Being tested
- exercise training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exercise trainingOther
subjects complete 4-5 weeks of training
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | 12-15 training sessions of 30 min over 4-5 weeks Receives: Other: exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skeletal muscle proteome signature
proteomics
Measured: Change from baseline proteome signature at 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2017
- Study start28 Aug 2017
- Primary completion15 Oct 2017
- Study completion15 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Morten Hostrup, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Morten Hostrup, PhD, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03270475
- Sponsor's protocol ID
- ACE
- Status last verified
- Jan 2021
- First submitted
- 28 Aug 2017
- Last updated
- 15 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Exercise Training on Skeletal Muscle Proteome Signature of Young Men
- ClinicalTrials.gov ID
- NCT03270475
- Acronym / sponsor ID
- ACE
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Morten Hostrup, PhDUniversity, hospital or other
- Study start
- 28 Aug 2017 (actual)
- Primary completion
- 15 Oct 2017 (actual)
- Study completion
- 15 Oct 2017 (actual)
- First posted
- 1 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study is to investigate skeletal muscle proteome signature changes induced by exercise training in young men
Detailed description
Advances in omics technologies have allowed for the identification of biomarkers with importance for the beneficial adaptations imposed by exercise training. Skeletal muscle exhibits remarkable plasticity to exercise training, as illustrated by pronounced alterations to the proteomic landscape, such as mitochondrial biogenesis. However, despite recent advances that have helped describe the proteomic landscape in response to a period of exercise training, our understanding of the processes pertaining to post-translation modification is scant. In this study, we aim to investigate the human acetylome and proteome in response to exercise training.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Other: exercise training12-15 training sessions of 30 min over 4-5 weeks |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy
- VO2max of 45-55 ml/kg/min (+/- SD) / 3000-4000 ml/min (+/- SD)
- Body mass index (BMI) of 19-26 kg/m2
- Normal ECG (electrocardiography)
Key exclusion criteria (2 listed)
- Serious adverse effects to exercise
- Chronic disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| exercise trainingsubjects complete 4-5 weeks of training | Other | Exercise |
Primary outcome
Skeletal muscle proteome signature
Time frame: Change from baseline proteome signature at 5 weeks
proteomics
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercise training in people with Healthy, run by Morten Hostrup, PhD at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skeletal muscle proteome signature (time frame: Change from baseline proteome signature at 5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2021.