The Effect of Berry Consumption on Indicators of Cardiovascular Disease Risk

Not Applicable

Completed

• Conditions: Blood Pressure; Platelet Function; Inflammation
• Interventions: Other: berry products; Other: control products

• Registration Number: NCT01019499
• Lead Sponsor: Finnish Institute for Health and Welfare

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.

Study Timeline

• Study Start: 2009-02
• Study First Submitted: 2009-11-24
• Study First Submitted QC: 2009-11-24
• Study First Posted: 2009-11-25
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Status Verified: 2010-06
• Last Update Submitted: 2010-06-18
• Last Update Posted: 2010-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
berry products	berry products	Berry products
control products	control products	Control products

Primary Outcome Measures

Name	Time	Method
Blood pressure	0, 8 and 16 weeks

Secondary Outcome Measures

Name	Time	Method
PFA-100 measurement	0, 8 and 16 weeks
biomarkers of cardiovascular disease risk	0, 8 and 16 weeks

Trial Locations

Locations (1)

National Institute for Health and Welfare; 🇫🇮 Turku, Finland