Healthy SubjectsPhase 2NCT00660491
Endothelial Dysfunction Induced by Postprandial Lipemia
A Phase 2 study testing exercise training in people with Healthy Subjects, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
Postprandial lipemia and exercise oppose each other in terms of cardiovascular risk, however the mechanism of their interaction is not well understood. Therefore we want to study vascular function, as assessed by brachial artery (BA) flow mediated dilation (FMD), in healthy men before and after a high fat meal (HFM)… Read more about this study
- Who is it for?
- Ages 20 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- exercise training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2008to Oct 2008
- Phase
- Phase 2
- 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 20 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- male, 20-40years, BMI between 25 and 30, resident in Trondheim.
Who cannot join
- unstable angina, CHD, heart failure,
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Endothelial Dysfunction Induced by Postprandial Lipemia: Complete Protection Afforded by High Intensity Aerobic Interval Exercise
Postprandial lipemia and exercise oppose each other in terms of cardiovascular risk, however the mechanism of their interaction is not well understood.
Therefore we want to study vascular function, as assessed by brachial artery (BA) flow mediated dilation (FMD), in healthy men before and after a high fat meal (HFM) preceded (16-18 hrs) by rest, a single bout of continuous moderate intensity exercise (CME), and high intensity interval exercise (HIIE).
- Conditions
- Healthy Subjects
- Being tested
- exercise training
- Keywords
- flow mediated dilatation, maximal oxygen uptake, blood lipid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exercise trainingOther
moderate intensity exercise group, and high intensity exercise group
| Study group | Role | What they receive |
|---|---|---|
| 1 | No intervention | Control |
| 2 | No intervention | moderate exercise training group |
| 3 | Experimental | high intensity exercise group Receives: Other: exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flow mediated dilatation
Measured: baseline, post exercise, 30min, 2hour, 4hour post exercise
Secondary outcomes (1)
blood lipid profile
Measured: same as flow mediated dilatation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2008 (estimated)
- Study startJan 2008
- Primary completionSep 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy SubjectsStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ulrik Wisloff, Professor, Study chair, National Taiwan Normal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00660491
- Sponsor's protocol ID
- Exercise, Food and Endothelium
- Status last verified
- Jan 2012
- First submitted
- 15 Apr 2008
- Last updated
- 6 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Tyldum GA, Schjerve IE, Tjonna AE, Kirkeby-Garstad I, Stolen TO, Richardson RS, Wisloff U. Endothelial dysfunction induced by post-prandial lipemia: complete protection afforded by high-intensity aerobic interval exercise. J Am Coll Cardiol. 2009 Jan 13;53(2):200-6. doi: 10.1016/j.jacc.2008.09.033.
PubMed 19130989
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endothelial Dysfunction Induced by Postprandial Lipemia: Complete Protection Afforded by High Intensity Aerobic Interval Exercise
- ClinicalTrials.gov ID
- NCT00660491
- Acronym / sponsor ID
- Exercise, Food and Endothelium
- Conditions
- Healthy Subjects
- Keywords
- flow mediated dilatation, maximal oxygen uptake, blood lipid
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Sep 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 17 Apr 2008 (estimated)
- 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.
Postprandial lipemia and exercise oppose each other in terms of cardiovascular risk, however the mechanism of their interaction is not well understood.
Therefore we want to study vascular function, as assessed by brachial artery (BA) flow mediated dilation (FMD), in healthy men before and after a high fat meal (HFM) preceded (16-18 hrs) by rest, a single bout of continuous moderate intensity exercise (CME), and high intensity interval exercise (HIIE).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | –Control |
| 2 | No intervention | –moderate exercise training group |
| 3 | Experimental | Other: exercise traininghigh intensity exercise group |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- male, 20-40years, BMI between 25 and 30, resident in Trondheim.
Key exclusion criteria (1 listed)
- unstable angina, CHD, heart failure,
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 trainingmoderate intensity exercise group, and high intensity exercise group | Other | 3 |
Primary outcome
Flow mediated dilatation
Time frame: baseline, post exercise, 30min, 2hour, 4hour post exercise
1 secondary outcome
blood lipid profile
Time frame: same as flow mediated dilatation
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 6 Jan 2012.
- Results publication: PubMed 19130989Tyldum GA, Schjerve IE, Tjonna AE, Kirkeby-Garstad I, Stolen TO, Richardson RS, Wisloff U. Endothelial dysfunction induced by post-prandial lipemia: complete protection afforded by high-intensity aerobic interval exercise. J Am Coll Cardiol. 2009 Jan 13;53(2):200-6. doi: 10.1016/j.jacc.2008.09.033.
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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.
Ulrik Wisloff, Professor study chair
National Taiwan Normal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing exercise training in people with Healthy Subjects, run by Norwegian University of Science and Technology at 1 site in Norway.
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 1 inclusion and 1 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 6 Jan 2012. 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 Norway. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Flow mediated dilatation (time frame: baseline, post exercise, 30min, 2hour, 4hour post exercise). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00660491, which also lists 1 linked publication.
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 6 Jan 2012.