Effects of Exercise With or Without Blueberries on Cardiovascular Risk Markers
Primary Purpose
Risk Factors Cardiovascular Disease, Inflammation, Exercise
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Blueberries
Sponsored by
About this trial
This is an interventional basic science trial for Risk Factors Cardiovascular Disease focused on measuring inflammation, lipids, CRP
Eligibility Criteria
Inclusion Criteria:
- healthy subjects
Exclusion Criteria:
- significant disease and disabilities that hinder running
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
conventional food
Blueberries
Arm Description
Regular eating habits during exercise period
Intervention: Addition of blueberries (150g/day) to regular food during the exercise period on days with exercise
Outcomes
Primary Outcome Measures
markers for cardiovascular disease
Insulin levels, glucose levels, lipids, hs-CRP, troponin T
Secondary Outcome Measures
Full Information
NCT ID
NCT01274078
First Posted
January 10, 2011
Last Updated
July 26, 2012
Sponsor
University Hospital, Linkoeping
1. Study Identification
Unique Protocol Identification Number
NCT01274078
Brief Title
Effects of Exercise With or Without Blueberries on Cardiovascular Risk Markers
Official Title
Effects of Exercise With or Without Blueberries on Cardiovascular Risk Markers
Study Type
Interventional
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
March 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Linkoeping
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Risk Factors Cardiovascular Disease, Inflammation, Exercise, Sedentary Life
Keywords
inflammation, lipids, CRP
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
conventional food
Arm Type
No Intervention
Arm Description
Regular eating habits during exercise period
Arm Title
Blueberries
Arm Type
Active Comparator
Arm Description
Intervention: Addition of blueberries (150g/day) to regular food during the exercise period on days with exercise
Intervention Type
Biological
Intervention Name(s)
Blueberries
Intervention Description
150 grams of frozen blueberries on the same day as exercise
Primary Outcome Measure Information:
Title
markers for cardiovascular disease
Description
Insulin levels, glucose levels, lipids, hs-CRP, troponin T
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
healthy subjects
Exclusion Criteria:
significant disease and disabilities that hinder running
Facility Information:
City
Linkoeping
Country
Sweden
12. IPD Sharing Statement
Learn more about this trial
Effects of Exercise With or Without Blueberries on Cardiovascular Risk Markers
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