The Effect of Berry Consumption on Indicators of Cardiovascular Disease Risk

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01019499

Enrollment

Registered

2009-11-25

Start date

2009-02-28

Completion date

2009-12-31

Last updated

2010-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood Pressure, Inflammation, Platelet Function

Keywords

human, intervention, blood pressure, cardiovascular risk factors, polyphenols, bioavailability

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.

Interventions

OTHERberry products

effects of berry consumption on cardiovascular indicators two portions daily

OTHERcontrol products

two portions daily

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

40 Years to 70 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Blood pressure	0, 8 and 16 weeks

Secondary

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

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026