The Effect of Berry Consumption on Indicators of Cardiovascular Disease Risk

Inflammation Clinical Trial

Official title:

The Effect of Berry Consumption on Indicators of Cardiovascular Disease Risk

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01019499
• Other study ID #: NPHIKTL
• Status: Completed
• Phase: N/A
• First received: November 24, 2009
• Last updated: June 18, 2010
• Start date: February 2009
• Est. completion date: December 2009

Study information

• Verified date: June 2010
• Source: National Institute for Health and Welfare, Finland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ethics Committee
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Blood Pressure
• Cardiovascular Diseases
• Inflammation
• Platelet Function

Intervention

Other:
• berry products
effects of berry consumption on cardiovascular indicators two portions daily
• control products
two portions daily

Locations

Country	Name	City	State
Finland	National Institute for Health and Welfare	Helsinki
Finland	National Institute for Health and Welfare	Turku

Sponsors (5)

Lead Sponsor	Collaborator
National Institute for Health and Welfare, Finland	Academy of Finland, Agrifood Research Finland, The Finnish Funding Agency for Technology and Innovation (TEKES), University of Oslo

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood pressure		0, 8 and 16 weeks	No
Secondary	PFA-100 measurement		0, 8 and 16 weeks	No
Secondary	biomarkers of cardiovascular disease risk		0, 8 and 16 weeks	No