The Effect of Berry Consumption on Indicators of Cardiovascular Disease Risk

This study has been completed.
Sponsor:
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
ClinicalTrials.gov Identifier:
NCT01019499
First received: November 24, 2009
Last updated: June 18, 2010
Last verified: June 2010
  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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • PFA-100 measurement [ Time Frame: 0, 8 and 16 weeks ] [ Designated as safety issue: No ]
  • biomarkers of cardiovascular disease risk [ Time Frame: 0, 8 and 16 weeks ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   40 Years to 70 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Iris Erlund, Senior researcher, National Institute for Health and Welfare
ClinicalTrials.gov Identifier: NCT01019499     History of Changes
Other Study ID Numbers: NPHIKTL
Study First Received: November 24, 2009
Last Updated: June 18, 2010
Health Authority: Finland: Ethics Committee

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

Additional relevant MeSH terms:
Cardiovascular Diseases
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on July 31, 2014