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Completed

NCT Number: NCT01019499

The Effect of Berry Consumption on Indicators of Cardiovascular Disease Risk

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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Key information

Conditions

Blood Pressure Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Platelet Function

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Institute for Health and Welfare, Helsinki, Finland

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

berry products

Other

effects of berry consumption on cardiovascular indicators

two portions daily

control products

Other

two portions daily

Primary outcomes

  1. Blood pressure

    Time frame: 0, 8 and 16 weeks

Secondary outcomes

  1. PFA-100 measurement

    Time frame: 0, 8 and 16 weeks

  2. biomarkers of cardiovascular disease risk

    Time frame: 0, 8 and 16 weeks

Sponsors and collaborators

Lead sponsor

Finnish Institute for Health and Welfare

Other Gov

Collaborators

  • Academy of Finland
  • Agrifood Research Finland
  • The Finnish Funding Agency for Technology and Innovation
  • University of Oslo

Registry information

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Nov 25, 2009
Registry last updated
Jun 22, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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