- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01274078
Effects of Exercise With or Without Blueberries on Cardiovascular Risk Markers
July 26, 2012 updated by: Fredrik H Nystrom, University Hospital, Linkoeping
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 Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
32
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
-
-
-
Linkoeping, Sweden
-
-
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 60 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- healthy subjects
Exclusion Criteria:
- significant disease and disabilities that hinder running
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: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: conventional food
Regular eating habits during exercise period
|
|
|
Active Comparator: Blueberries
Intervention: Addition of blueberries (150g/day) to regular food during the exercise period on days with exercise
|
150 grams of frozen blueberries on the same day as exercise
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
markers for cardiovascular disease
Time Frame: 3 months
|
Insulin levels, glucose levels, lipids, hs-CRP, troponin T
|
3 months
|
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
July 1, 2010
Primary Completion (Actual)
December 1, 2010
Study Completion (Actual)
March 1, 2011
Study Registration Dates
First Submitted
January 10, 2011
First Submitted That Met QC Criteria
January 10, 2011
First Posted (Estimate)
January 11, 2011
Study Record Updates
Last Update Posted (Estimate)
July 27, 2012
Last Update Submitted That Met QC Criteria
July 26, 2012
Last Verified
July 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FHN_exc_blueberries
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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