MedDataX Logo

The Water-Blueberry Study

NCT ID: NCT00520871

Last Updated: 2007-08-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-03-31

Study Completion Date

2004-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cardiovascular Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Blueberry juice

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ullevaal University Hospital

OTHER

Sponsor Role collaborator

University of Oslo

OTHER

Sponsor Role lead

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Rune Blomhoff, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Oslo

Serena Tonstad, MD

Role: PRINCIPAL_INVESTIGATOR

Ullevaal University Hospital

Anette Karlsen, MSc

Role: PRINCIPAL_INVESTIGATOR

University of Oslo

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

REK SØR ref nr 39-03-01166

Identifier Type: -

Identifier Source: secondary_id

Water-Blueberry Study

Identifier Type: -

Identifier Source: org_study_id