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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01019499
Other study ID # NPHIKTL
Secondary ID
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


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
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