The Water-Blueberry Study - Full Text View

Sponsors and Collaborators:	University of Oslo Ullevaal University Hospital
Information provided by:	University of Oslo
ClinicalTrials.gov Identifier:	NCT00520871

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 I Phase II

MedlinePlus related topics: Antioxidants Drinking Water

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study
Official Title:	The Effect of Blueberry Juice on Cardiovascular Risk Factors, and Markers of Antioxidant Status, Oxidative Stress Status and Inflammation.

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

Ages Eligible for Study:	30 Years to 70 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Study ID Numbers:	Water-Blueberry Study, REK SØR ref nr 39-03-01166
Study First Received:	August 24, 2007
Last Updated:	August 24, 2007
ClinicalTrials.gov Identifier:	NCT00520871 History of Changes
Health Authority:	Norway: The National Committees for Research Ethics in Norway

Keywords provided by University of Oslo:

Cardiovascular disease
Blueberruy
Antioxidants
Oxidative stress
Inflammation

Study placed in the following topic categories:

Antioxidants
Stress
Inflammation

Additional relevant MeSH terms:

Antioxidants
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

Cardiovascular Diseases
Protective Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009