HealthyNCT03317704
Regulation of Metabolism and Ion Handling
A study testing Speed endurance training in people with Healthy, run by Morten Hostrup, PhD at 1 site in Denmark.
Trial summary
This study investigates the relation between ion-handling (K+) and fatigue development during exercise. Before and after a 6-week period of high intensity interval training, performance and ion-handling is assessed in young adults. In addition, mitochondrial function is examined. 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?
- Speed endurance training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteDenmark
- Study dates
- 25 Oct 2017to 20 May 2020
- 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 men
- 45-55 ml/kg/min
- BMI 19-26 kg/m2
- Normal ECG (assessed by MD)
Who cannot join
- Allergic to n-acetylcystine (NAC) or digoxin
- Severe side effects from NAC or digoxin
- Chronic diseases (assessed by MD to be a potential hazard or to interfere with outcome measures)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Regulation of Metabolism and Ion Handling - Effect of High Intensity Training and NAC-infusion in Young Men
This study investigates the relation between ion-handling (K+) and fatigue development during exercise. Before and after a 6-week period of high intensity interval training, performance and ion-handling is assessed in young adults. In addition, mitochondrial function is examined.
- Conditions
- Healthy
- Being tested
- Speed endurance training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Speed endurance trainingBehavioural
Speed endurance training
| Study group | Role | What they receive |
|---|---|---|
| speed endurance training (SET) | Active comparator | Training 6 weeks 3 times pr. week Receives: Behavioral: Speed endurance training |
| Controls | No intervention | Asked to continue their usual life style |
| speed endurance training (SET) II | Active comparator | Training 6 weeks 3 times pr. week Receives: Behavioral: Speed endurance training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quadriceps endurance
Time to exhaustion during knee-extensor exercise
Measured: Change from before (baseline) to after 6 weeks of training (Week 6)
Secondary outcomes (1)
K+ release
Net leg K+ release in mmol/min during knee-extensor exercise
Measured: Change from before (baseline) to after 6 weeks of training (Week 6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2017
- Study start25 Oct 2017
- Primary completion18 Dec 2019
- Study completion20 May 2020
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 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
- NCT03317704
- Sponsor's protocol ID
- SET-NAC
- Status last verified
- Sep 2020
- First submitted
- 3 Oct 2017
- Last updated
- 10 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- 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 10 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regulation of Metabolism and Ion Handling - Effect of High Intensity Training and NAC-infusion in Young Men
- ClinicalTrials.gov ID
- NCT03317704
- Acronym / sponsor ID
- SET-NAC
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Morten Hostrup, PhDUniversity, hospital or other
- Study start
- 25 Oct 2017 (actual)
- Primary completion
- 18 Dec 2019 (actual)
- Study completion
- 20 May 2020 (actual)
- First posted
- 23 Oct 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.
This study investigates the relation between ion-handling (K+) and fatigue development during exercise. Before and after a 6-week period of high intensity interval training, performance and ion-handling is assessed in young adults. In addition, mitochondrial function is examined.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| speed endurance training (SET) | Active comparator | Behavioral: Speed endurance trainingTraining 6 weeks 3 times pr. week |
| Controls | No intervention | –Asked to continue their usual life style |
| speed endurance training (SET) II | Active comparator | Behavioral: Speed endurance trainingTraining 6 weeks 3 times pr. week |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy men
- 45-55 ml/kg/min
- BMI 19-26 kg/m2
- Normal ECG (assessed by MD)
Key exclusion criteria (3 listed)
- Allergic to n-acetylcystine (NAC) or digoxin
- Severe side effects from NAC or digoxin
- Chronic diseases (assessed by MD to be a potential hazard or to interfere with outcome measures)
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 |
|---|---|---|
| Speed endurance trainingSpeed endurance training | Behavioural | speed endurance training (SET), speed endurance training (SET) II |
Primary outcome
Quadriceps endurance
Time frame: Change from before (baseline) to after 6 weeks of training (Week 6)
Time to exhaustion during knee-extensor exercise
1 secondary outcome
K+ release
Time frame: Change from before (baseline) to after 6 weeks of training (Week 6)
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 10 Sep 2020.
- 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 Speed endurance 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 3 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 10 Sep 2020. 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?
Quadriceps endurance (time frame: Change from before (baseline) to after 6 weeks of training (Week 6)). 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 10 Sep 2020.