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The Water-Blueberry Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00520871
First Posted: August 27, 2007
Last Update Posted: August 27, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Ullevaal University Hospital
Information provided by:
University of Oslo
  Purpose
We will study the effect of supplementation of 1 L blueberry juice to participants with at least one elevated cardiovasculat risk factor.

Condition Intervention Phase
Cardiovascular Disease Drug: Blueberry juice Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Prevention
Official Title: The Effect of Blueberry Juice on Cardiovascular Risk Factors, and Markers of Antioxidant Status, Oxidative Stress Status and Inflammation.

Resource links provided by NLM:


Further study details as provided by University of Oslo:

Primary Outcome Measures:
  • Primary endpoints are cardiovascular risk factors [ Time Frame: 4 weeks ]

Secondary Outcome Measures:
  • Secondary endpoints are additional clinical markers, as well as biomarkers of antioxidant status, oxidative stress status and inflammation [ Time Frame: 4 weeks ]

Enrollment: 62
Study Start Date: March 2003
Study Completion Date: April 2004
Detailed Description:

Participants with at leat one elevated cardiovacsular risk factor, as defined as systolic blood pressure between 140 and 165 mmHg, diastolic blood pressure between 90 and 105 mmHg, low density lipoprotein (LDL) cholesterol ≥3.4 mmol/L, total/high density lipoprotein (HDL) cholesterol ratio >4 or smoking a minimum of 3 cigarettes daily.

Subjects were randomized to two groups, where the blueberry group were supplemented with 1 L blueberry juice per day for four weeks. The control group consumed an equal amount of water.

Clinical markers, as well as biomarkers of antioxidant status, oxidative stress status and inflammation were measured in blood samples before amd after the intervention period.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 30-70 years for men and 45-70 years or at least 12 months postmenopausal for women
  • at least one elevated cardiovascular risk factor, defined as systolic blood pressure between 140 and 165 mmHg, diastolic blood pressure between 90 and 105 mmHg, low density lipoprotein (LDL) cholesterol ≥3.4 mmol/L, total/high density lipoprotein (HDL) cholesterol ratio >4 or smoking a minimum of 3 cigarettes daily.

Exclusion Criteria:

  • clinically recognized chronic diseases as impaired renal function, diabetes mellitus, cardiovascular disease, liver or gastrointestinal disease or cancer within the last 5 years
  • use of lipid-lowering drugs, diuretics or hormone replacement therapy for women
  • Subjects with a body-mass index ≥31
  • with a alcohol consumption above 3 units/day for men and 1 unit/day for women
  • blood donation within the last six months
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00520871


Sponsors and Collaborators
University of Oslo
Ullevaal University Hospital
Investigators
Principal Investigator: Rune Blomhoff, PhD University of Oslo
Principal Investigator: Serena Tonstad, MD Ullevaal University Hospital
Principal Investigator: Anette Karlsen, MSc University of Oslo
  More Information

ClinicalTrials.gov Identifier: NCT00520871     History of Changes
Other Study ID Numbers: Water-Blueberry Study
REK SØR ref nr 39-03-01166
First Submitted: August 24, 2007
First Posted: August 27, 2007
Last Update Posted: August 27, 2007
Last Verified: August 2007

Keywords provided by University of Oslo:
Cardiovascular disease
Blueberruy
Antioxidants
Oxidative stress
Inflammation

Additional relevant MeSH terms:
Cardiovascular Diseases
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs