The Effect of Berry Consumption on Indicators of Cardiovascular Disease Risk

June 18, 2010 updated by: Finnish Institute for Health and Welfare
The purpose of this study is to investigate the effects of berry consumption on indicators of cardiovascular disease risk (blood pressure, cardiovascular biomarkers, nutrigenomics).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study has a randomized crossover design. It consists of two 8-wk dietary treatments, with no washout period between periods. The participants are blinded to treatments. The subjects are randomly assigned to either a berry diet or a control diet which they follow for 8 weeks. After that they are crossed over to the other diet for another 8 weeks. The main visits to the study site are at baseline and after 8 and 16 weeks (for blood pressure measurement/ cardiovascular measurements and sample collection). The additional visits are at 4 and 12 wk; these visits are for compliance checks, meeting the study nurse and receiving the study products. The subjects are asked to maintain their normal dietary and lifestyle habits, as well as to keep alcohol intake and physical activity constant during the study.

Study Type

Interventional

Enrollment (Anticipated)

37

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Helsinki, Finland, 00300
        • National Institute for Health and Welfare
      • Turku, Finland, 20720
        • National Institute for Health and Welfare

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • mild hypertension (systolic blood pressure 130-159 mmHg, diastolic blood pressure 85-99 mmHg)

Exclusion Criteria:

  • smoking
  • regular use of medications (except hormone replacement therapy) or dietary supplements
  • intestinal disorders
  • obesity (BMI> 35 kg/m2)
  • vegetarianism
  • pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: berry products
Berry products
Other: berry products

effects of berry consumption on cardiovascular indicators

two portions daily
Placebo Comparator: control products
Control products
Other: control products
two portions daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Blood pressure
Time Frame: 0, 8 and 16 weeks
0, 8 and 16 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
PFA-100 measurement
Time Frame: 0, 8 and 16 weeks
0, 8 and 16 weeks
biomarkers of cardiovascular disease risk
Time Frame: 0, 8 and 16 weeks
0, 8 and 16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Finnish Institute for Health and Welfare

Collaborators

University of Oslo
Academy of Finland
The Finnish Funding Agency for Technology and Innovation (TEKES)
Agrifood Research Finland

Investigators

  • Study Director: Antti Jula, Dr., Finnish Institute for Health and Welfare

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

November 24, 2009

First Submitted That Met QC Criteria

November 24, 2009

First Posted (Estimate)

November 25, 2009

Study Record Updates

Last Update Posted (Estimate)

June 22, 2010

Last Update Submitted That Met QC Criteria

June 18, 2010

Last Verified

June 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NPHIKTL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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