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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
University Hospital, Linkoeping
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Risk Factors Cardiovascular Disease focused on measuring inflammation, lipids, CRP

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

First Posted
January 10, 2011
Last Updated
July 26, 2012
Sponsor
University Hospital, Linkoeping
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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

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Effects of Exercise With or Without Blueberries on Cardiovascular Risk Markers

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