NCT01019499

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2009

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 24, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 25, 2009

Completed
6 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

June 22, 2010

Status Verified

June 1, 2010

Enrollment Period

10 months

First QC Date

November 24, 2009

Last Update Submit

June 18, 2010

Conditions

Blood PressurePlatelet FunctionInflammation

Keywords

humaninterventionblood pressurecardiovascular risk factorspolyphenolsbioavailability

Outcome Measures

Primary Outcomes (1)

  • Blood pressure

    0, 8 and 16 weeks

Secondary Outcomes (2)

  • PFA-100 measurement

    0, 8 and 16 weeks

  • biomarkers of cardiovascular disease risk

    0, 8 and 16 weeks

Study Arms (2)

berry products

ACTIVE COMPARATOR

Berry products

Other: berry products

control products

PLACEBO COMPARATOR

Control products

Other: control products

Interventions

berry productsOTHER

effects of berry consumption on cardiovascular indicators two portions daily

berry products
control productsOTHER

two portions daily

control products

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • mild hypertension (systolic blood pressure 130-159 mmHg, diastolic blood pressure 85-99 mmHg)

You may not qualify if:

  • smoking
  • regular use of medications (except hormone replacement therapy) or dietary supplements
  • intestinal disorders
  • obesity (BMI\> 35 kg/m2)
  • vegetarianism
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

National Institute for Health and Welfare

Helsinki, Helsinki, 00300, Finland

Location

National Institute for Health and Welfare

Turku, Turku, 20720, Finland

Location

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Antti Jula, DR.

    Finnish Institute for Health and Welfare

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

November 24, 2009

First Posted

November 25, 2009

Study Start

February 1, 2009

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

June 22, 2010

Record last verified: 2010-06

Locations

FI(2)