The Effect of Berry Consumption on Indicators of Cardiovascular Disease Risk

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2009-12-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Blood Pressure Platelet Function Inflammation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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berry products

Berry products

Group Type ACTIVE_COMPARATOR

berry products

Intervention Type OTHER

effects of berry consumption on cardiovascular indicators

two portions daily

control products

Control products

Group Type PLACEBO_COMPARATOR

control products

Intervention Type OTHER

two portions daily

Interventions

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berry products

effects of berry consumption on cardiovascular indicators

two portions daily

Intervention Type OTHER

control products

two portions daily

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes