NCT01274078

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2010

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2010

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 10, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 11, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

July 27, 2012

Status Verified

July 1, 2012

Enrollment Period

5 months

First QC Date

January 10, 2011

Last Update Submit

July 26, 2012

Conditions

Risk Factors Cardiovascular DiseaseInflammationExerciseSedentary Life

Keywords

inflammationlipidsCRP

Outcome Measures

Primary Outcomes (1)

  • markers for cardiovascular disease

    Insulin levels, glucose levels, lipids, hs-CRP, troponin T

    3 months

Study Arms (2)

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

Biological: Blueberries

Interventions

BlueberriesBIOLOGICAL

150 grams of frozen blueberries on the same day as exercise

Blueberries

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy subjects

You may not qualify if:

  • significant disease and disabilities that hinder running

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Linköping, Sweden

Location

MeSH Terms

Conditions

InflammationMotor Activity

Interventions

blueberry extract

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD professor

Study Record Dates

First Submitted

January 10, 2011

First Posted

January 11, 2011

Study Start

July 1, 2010

Primary Completion

December 1, 2010

Study Completion

March 1, 2011

Last Updated

July 27, 2012

Record last verified: 2012-07

Locations

SE(1)