The Effect of Berry Consumption on Indicators of Cardiovascular Disease Risk

Sponsor

Finnish Institute for Health and Welfare (Other)

Overall Status

Completed

CT.gov ID

NCT01019499

Collaborator

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

Enrollment

Locations

Arms

Duration (Months)

18.5

Patients Per Site

1.9

Patients Per Site Per Month

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Blood Pressure Platelet Function Inflammation	Other: berry products Other: control products	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

37 participants

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

Study Start Date :

Feb 1, 2009

Actual Primary Completion Date :

Dec 1, 2009

Actual Study Completion Date :

Dec 1, 2009

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Blood pressure [0, 8 and 16 weeks]

Secondary Outcome Measures

PFA-100 measurement [0, 8 and 16 weeks]
biomarkers of cardiovascular disease risk [0, 8 and 16 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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