Risk Factors Cardiovascular DiseaseNCT01274078
Effects of Exercise With or Without Blueberries on Cardiovascular Risk Markers
A study testing Blueberries in people with Risk Factors Cardiovascular Disease and Inflammation, run by University Hospital, Linkoeping at 1 site in Sweden.
Trial summary
About 32 healthy subjects are subjected to 4 weeks of exercise, 4 weeks of washout and 4 weeks of sedentary life style, randomization decides whether they start with exercise or with being "couch potatoes". All participants are also randomized to also consume 150 g of blueberries on exercise days or not. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Risk Factors Cardiovascular Disease, Inflammation, Exercise
- What is being tested?
- Blueberries
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteSweden
- Study dates
- Jul 2010to Mar 2011
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy subjects
Who cannot join
- significant disease and disabilities that hinder running
Trial locations and contacts
1 site in 1 country.
About this study
About 32 healthy subjects are subjected to 4 weeks of exercise, 4 weeks of washout and 4 weeks of sedentary life style, randomization decides whether they start with exercise or with being "couch potatoes". All participants are also randomized to also consume 150 g of blueberries on exercise days or not. The exercise is constituted of 5 km running 5 days a week during the 4 week period. The exercise period and the "couch" period are started and ended with a 5 km run at maximal speed and the fasting blood samples for cardiovascular risk factors are measured before and after this run, ie 8 times in total.
- Being tested
- Blueberries
- Keywords
- inflammation, lipids, CRP
- Medical subject headings
- Inflammation, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BlueberriesBiological
150 grams of frozen blueberries on the same day as exercise
| Study group | Role | What they receive |
|---|---|---|
| conventional food | No intervention | Regular eating habits during exercise period |
| Blueberries | Active comparator | Intervention: Addition of blueberries (150g/day) to regular food during the exercise period on days with exercise Receives: Biological: Blueberries |
What is being measured
The primary outcome is the main question the study is designed to answer.
markers for cardiovascular disease
Insulin levels, glucose levels, lipids, hs-CRP, troponin T
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2011 (estimated)
- Study startJul 2010
- Primary completionDec 2010
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Risk Factors Cardiovascular DiseaseStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Linkoeping
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fredrik H Nystrom, University Hospital, Linkoeping
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01274078
- Sponsor's protocol ID
- FHN_exc_blueberries
- Status last verified
- Jul 2012
- First submitted
- 10 Jan 2011
- Last updated
- 27 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Exercise With or Without Blueberries on Cardiovascular Risk Markers
- ClinicalTrials.gov ID
- NCT01274078
- Acronym / sponsor ID
- FHN_exc_blueberries
- Keywords
- inflammation, lipids, CRP
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University Hospital, LinkoepingUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 11 Jan 2011 (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.
About 32 healthy subjects are subjected to 4 weeks of exercise, 4 weeks of washout and 4 weeks of sedentary life style, randomization decides whether they start with exercise or with being "couch potatoes". All participants are also randomized to also consume 150 g of blueberries on exercise days or not. The exercise is constituted of 5 km running 5 days a week during the 4 week period. The exercise period and the "couch" period are started and ended with a 5 km run at maximal speed and the fasting blood samples for cardiovascular risk factors are measured before and after this run, ie 8 times in total.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional food | No intervention | –Regular eating habits during exercise period |
| Blueberries | Active comparator | Biological: BlueberriesIntervention: Addition of blueberries (150g/day) to regular food during the exercise period on days with exercise |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- healthy subjects
Key exclusion criteria (1 listed)
- significant disease and disabilities that hinder running
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 |
|---|---|---|
| Blueberries150 grams of frozen blueberries on the same day as exercise | Biological | Blueberries |
Primary outcome
markers for cardiovascular disease
Time frame: 3 months
Insulin levels, glucose levels, lipids, hs-CRP, troponin T
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 27 Jul 2012.
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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 Blueberries in people with Risk Factors Cardiovascular Disease and Inflammation, run by University Hospital, Linkoeping at 1 site in Sweden.
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 27 Jul 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 Sweden. 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?
markers for cardiovascular disease (time frame: 3 months). 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 27 Jul 2012.