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The Effect of Berry Consumption on Indicators of Cardiovascular Disease Risk

Primary Purpose

Blood Pressure, Platelet Function, Inflammation

Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
berry products
control products
Sponsored by
Finnish Institute for Health and Welfare
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Blood Pressure focused on measuring human, intervention, blood pressure, cardiovascular risk factors, polyphenols, bioavailability

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • National Institute for Health and Welfare
  • National Institute for Health and Welfare

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

berry products

control products

Arm Description

Berry products

Control products

Outcomes

Primary Outcome Measures

Blood pressure

Secondary Outcome Measures

PFA-100 measurement
biomarkers of cardiovascular disease risk

Full Information

First Posted
November 24, 2009
Last Updated
June 18, 2010
Sponsor
Finnish Institute for Health and Welfare
Collaborators
Agrifood Research Finland, The Finnish Funding Agency for Technology and Innovation (TEKES), Academy of Finland, University of Oslo
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1. Study Identification

Unique Protocol Identification Number
NCT01019499
Brief Title
The Effect of Berry Consumption on Indicators of Cardiovascular Disease Risk
Official Title
The Effect of Berry Consumption on Indicators of Cardiovascular Disease Risk
Study Type
Interventional

2. Study Status

Record Verification Date
June 2010
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Finnish Institute for Health and Welfare
Collaborators
Agrifood Research Finland, The Finnish Funding Agency for Technology and Innovation (TEKES), Academy of Finland, University of Oslo

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to investigate the effects of berry consumption on indicators of cardiovascular disease risk (blood pressure, cardiovascular biomarkers, nutrigenomics).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blood Pressure, Platelet Function, Inflammation
Keywords
human, intervention, blood pressure, cardiovascular risk factors, polyphenols, bioavailability

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
37 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
berry products
Arm Type
Active Comparator
Arm Description
Berry products
Arm Title
control products
Arm Type
Placebo Comparator
Arm Description
Control products
Intervention Type
Other
Intervention Name(s)
berry products
Intervention Description
effects of berry consumption on cardiovascular indicators two portions daily
Intervention Type
Other
Intervention Name(s)
control products
Intervention Description
two portions daily
Primary Outcome Measure Information:
Title
Blood pressure
Time Frame
0, 8 and 16 weeks
Secondary Outcome Measure Information:
Title
PFA-100 measurement
Time Frame
0, 8 and 16 weeks
Title
biomarkers of cardiovascular disease risk
Time Frame
0, 8 and 16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antti Jula, DR.
Organizational Affiliation
Finnish Institute for Health and Welfare
Official's Role
Study Director
Facility Information:
Facility Name
National Institute for Health and Welfare
City
Helsinki
ZIP/Postal Code
00300
Country
Finland
Facility Name
National Institute for Health and Welfare
City
Turku
ZIP/Postal Code
20720
Country
Finland

12. IPD Sharing Statement

Learn more about this trial

The Effect of Berry Consumption on Indicators of Cardiovascular Disease Risk

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