NCT00520871

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

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

Enrollment
62

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Mar 2003

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

March 1, 2003

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2004

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

August 24, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 27, 2007

Completed
Last Updated

August 27, 2007

Status Verified

August 1, 2007

First QC Date

August 24, 2007

Last Update Submit

August 24, 2007

Conditions

Cardiovascular Disease

Keywords

Cardiovascular diseaseBlueberruyAntioxidantsOxidative stressInflammation

Outcome Measures

Primary Outcomes (1)

  • Primary endpoints are cardiovascular risk factors

    4 weeks

Secondary Outcomes (1)

  • Secondary endpoints are additional clinical markers, as well as biomarkers of antioxidant status, oxidative stress status and inflammation

    4 weeks

Interventions

Blueberry juiceDRUG

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cardiovascular DiseasesInflammation

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Rune Blomhoff, PhD

    University of Oslo

    PRINCIPAL INVESTIGATOR

  • Serena Tonstad, MD

    Ullevaal University Hospital

    PRINCIPAL INVESTIGATOR

  • Anette Karlsen, MSc

    University of Oslo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 24, 2007

First Posted

August 27, 2007

Study Start

March 1, 2003

Study Completion

April 1, 2004

Last Updated

August 27, 2007

Record last verified: 2007-08