NCT01130129

Brief Summary

Consumption of a diet rich in fruit and vegetables is associated with a reduced risk of cardiovascular disease and the protective effect may be due to polyphenolic compounds contained within these foods. The mechanism by which polyphenols exert this effect is not clearly understood but research has focused on their potential to affect platelet function. The purpose of this study is to quantify the anti-clotting activity of a range of plant food extracts and component compounds.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Jun 2010

Typical duration for not_applicable healthy

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

May 24, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 25, 2010

Completed
7 days until next milestone

Study Start

First participant enrolled

June 1, 2010

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

March 6, 2013

Status Verified

March 1, 2013

Enrollment Period

1 year

First QC Date

May 24, 2010

Last Update Submit

March 5, 2013

Conditions

Keywords

FlavonoidsPlatelets

Outcome Measures

Primary Outcomes (1)

  • Identification of flavonoids that exert a significant anti-clotting effect

    within 4hours

Study Arms (1)

Ex-vivo treatment of platelets

EXPERIMENTAL

Ex-vivo treatment of platelets

Other: Ex-vivo treatments with flavonoids

Interventions

Ex-vivo treatment of platelets with a range of flavonoids

Ex-vivo treatment of platelets

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males and females
  • Aged 18 - 65 years.
  • BMI \> 19.5 and \< 35
  • Non-smokers

You may not qualify if:

  • Pregnancy or have been pregnant within the last 12 months
  • Parallel participation in another research project which involves dietary intervention
  • Participation in another research project which has involved blood sampling within the last four months unless the total amount of combined blood from both studies does not exceed 470 mls.
  • Has donated or intends to donate blood within 16 weeks prior to during the Study period.
  • Depressed or elevated blood pressure measurements (\<90/50 or 95/50 if symptomatic or \>160/100)
  • Any person related to or living with any member of the study team
  • Diabetics
  • Taking regular prescribed and/or non-prescribed medication (excluding oral contraceptive and HRT).
  • Known bleeding disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Food Research

Norwich, Norfolk, NR4 7UA, United Kingdom

Location

MeSH Terms

Interventions

Flavonoids

Intervention Hierarchy (Ancestors)

ChromonesBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Paul Kroon, phD

    Quadram Institute Bioscience

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 24, 2010

First Posted

May 25, 2010

Study Start

June 1, 2010

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

March 6, 2013

Record last verified: 2013-03

Locations