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The Effects of Plant Bioactives on Platelet Function

This study has been completed.
Sponsor:
Collaborator:
European Union
Information provided by (Responsible Party):
Institute of Food Research
ClinicalTrials.gov Identifier:
NCT01130129
First received: May 24, 2010
Last updated: March 5, 2013
Last verified: March 2013
History of Changes
  Purpose

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.


Condition Intervention
Healthy
 Other: Ex-vivo treatments with flavonoids

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: The Effects of Plant Bioactives on Platelet Function

Further study details as provided by Institute of Food Research:

Primary Outcome Measures:
  • Identification of flavonoids that exert a significant anti-clotting effect [ Time Frame: within 4hours ] [ Designated as safety issue: No ]

Enrollment: 15
Study Start Date: June 2010
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ex-vivo treatment of platelets
Ex-vivo treatment of platelets
 Other: Ex-vivo treatments with flavonoids
Ex-vivo treatment of platelets with a range of flavonoids

Detailed Description:

A single sample of whole blood will be collected from 15 male or female volunteers aged between 18 and 65 years. After collection whole blood will be treated with a range of flavonoids to evaluate their effects on platelet function.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01130129

Locations
United Kingdom
Institute of Food Research
Norwich, Norfolk, United Kingdom, NR4 7UA
Sponsors and Collaborators
Institute of Food Research
European Union
Investigators
Principal Investigator: Paul Kroon, phD Institute of Food Research
  More Information

No publications provided

Responsible Party: Institute of Food Research
ClinicalTrials.gov Identifier: NCT01130129     History of Changes
Other Study ID Numbers: IFR02/2009
Study First Received: May 24, 2010
Last Updated: March 5, 2013
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Institute of Food Research:
Flavonoids
Platelets

ClinicalTrials.gov processed this record on May 16, 2013