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The Effect of Berry Consumption on Indicators of Cardiovascular Disease Risk

F

Finnish Institute for Health and Welfare

Status

Completed

Conditions

Inflammation
Platelet Function
Blood Pressure

Treatments

Other: control products
Other: berry products

Study type

Interventional

Funder types

Other

Identifiers

NCT01019499
NPHIKTL

Details and patient eligibility

About

The purpose of this study is to investigate the effects of berry consumption on indicators of cardiovascular disease risk (blood pressure, cardiovascular biomarkers, nutrigenomics).

Full 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.

Enrollment

37 estimated patients

Sex

All

Ages

40 to 70 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Quadruple Blind

37 participants in 2 patient groups, including a placebo group

berry products
Active Comparator group
Description:
Berry products
Treatment:
Other: berry products
control products
Placebo Comparator group
Description:
Control products
Treatment:
Other: control products

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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