The Water-Blueberry Study

Cardiovascular Disease Clinical Trial

Official title:

The Effect of Blueberry Juice on Cardiovascular Risk Factors, and Markers of Antioxidant Status, Oxidative Stress Status and Inflammation.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00520871
• Other study ID #: Water-Blueberry Study
• Secondary ID: REK SØR ref nr 3
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: August 24, 2007
• Last updated: August 24, 2007
• Start date: March 2003
• Est. completion date: April 2004

Study information

• Verified date: August 2007
• Source: University of Oslo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research Ethics
• Study type: Interventional

Clinical Trial Summary

We will study the effect of supplementation of 1 L blueberry juice to participants with at least one elevated cardiovasculat risk factor.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: April 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases

Intervention

Drug:
• Blueberry juice

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Oslo	Ullevaal University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary endpoints are cardiovascular risk factors		4 weeks
Secondary	Secondary endpoints are additional clinical markers, as well as biomarkers of antioxidant status, oxidative stress status and inflammation		4 weeks