We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Effect of Berry Consumption on Indicators of Cardiovascular Disease Risk

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01019499
First Posted: November 25, 2009
Last Update Posted: June 22, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Agrifood Research Finland
The Finnish Funding Agency for Technology and Innovation (TEKES)
Academy of Finland
University of Oslo
Information provided by:
National Institute for Health and Welfare, Finland
  Purpose
The purpose of this study is to investigate the effects of berry consumption on indicators of cardiovascular disease risk (blood pressure, cardiovascular biomarkers, nutrigenomics).

Condition Intervention
Blood Pressure Platelet Function Inflammation Other: berry products Other: control products

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: The Effect of Berry Consumption on Indicators of Cardiovascular Disease Risk

Further study details as provided by National Institute for Health and Welfare, Finland:

Primary Outcome Measures:
  • Blood pressure [ Time Frame: 0, 8 and 16 weeks ]

Secondary Outcome Measures:
  • PFA-100 measurement [ Time Frame: 0, 8 and 16 weeks ]
  • biomarkers of cardiovascular disease risk [ Time Frame: 0, 8 and 16 weeks ]

Estimated Enrollment: 37
Study Start Date: February 2009
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   40 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01019499


Locations
Finland
National Institute for Health and Welfare
Helsinki, Finland, 00300
National Institute for Health and Welfare
Turku, Finland, 20720
Sponsors and Collaborators
National Institute for Health and Welfare, Finland
Agrifood Research Finland
The Finnish Funding Agency for Technology and Innovation (TEKES)
Academy of Finland
University of Oslo
Investigators
Study Director: Antti Jula, DR. National Institute for Health and Welfare, Finland
  More Information

Responsible Party: Iris Erlund, Senior researcher, National Institute for Health and Welfare
ClinicalTrials.gov Identifier: NCT01019499     History of Changes
Other Study ID Numbers: NPHIKTL
First Submitted: November 24, 2009
First Posted: November 25, 2009
Last Update Posted: June 22, 2010
Last Verified: June 2010

Keywords provided by National Institute for Health and Welfare, Finland:
human
intervention
blood pressure
cardiovascular risk factors
polyphenols
bioavailability

Additional relevant MeSH terms:
Inflammation
Cardiovascular Diseases
Pathologic Processes