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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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30 April 2018 |
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Main ID: |
ISRCTN84856452 |
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Date of registration:
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16/02/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Mechanistic and efficacy studies on a tomato extract with antiplatelet properties
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Scientific title:
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Assessing possible interactions between Fruitflow tomato extract and aspirin in apparently healthy subjects |
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Date of first enrolment:
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01/05/2007 |
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Target sample size:
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46 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN84856452 |
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Study type:
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Interventional |
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Study design:
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Single-centre intervention study following a randomised double-blinded placebo-controlled cross over design with two treatments (Other)
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Phase:
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Niamh
O'Kennedy |
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Address:
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Polwarth Building
Foresterhill
University of Aberdeen
AB25 2ZD
Aberdeen
United Kingdom |
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Email:
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Affiliation:
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Name:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Healthy subjects
2. Male and female
3. 45 - 75 years of age
4. Normal platelet function
Exclusion criteria: 1. Low platelet number in whole blood (< 170 x 109/ L)
2. Hematocrit below 40% for males or below 35% for females
3. Haemoglobin below 120 g/L for males or below 110 g/L for females
4. Prothrombin time (PT) values outside the normal range of approximately 10 – 16 s
5. BMI below 18 or above 38 kg/m2
6. Overt vascular or haematological disease, hypertension or infection
7. Clinically significant chronic illnesses
8. Known susceptibility to GI irritation, e.g. history of gastric ulcers
9. Consumption of aspirin, corticosteroids, other (non steroidal) anti-inflammatory drugs or other drugs or herbal medicines known to alter platelet function or the haemostatic system in general (without a minimum washout period of two weeks)
10. Consumption of evening primrose oil or fish oil supplements (without a minimum washout period of one month)
11. Consumption of a contraceptive pill or hormone replacement therapy
12. Pregnancy
13. Intolerance/allergy to aspirin
14. Allergy to tomatoes
15. Unsuitable veins for blood sampling and/or cannulation
16. Donation of one pint of blood or more for transfusion purposes in the past month before entry into the study
17. Smoking
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Examination of platelet function and response to potentially beneficial dietary supplements in healthy subjects
Not Applicable
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Intervention(s)
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The study involved two base treatments, either 75mg aspirin (plus three placebo capsules) taken once per day for seven consecutive days, or an apparently identical control capsule set. On day 1, a baseline blood sample was taken before consuming the first intervention supplement, and the acute effect of this supplement was assessed at t=3 and t=5 hours. Subjects then departed, taking with them a supply of capsules to be taken once per day for the following seven days. On the morning of day 8, subjects returned to the study unit, and a blood sample was taken to measure the effect of the supplements they had taken for the intervening seven days. The subjects then consumed 3g of the tomato extract, concomitantly with their seven-day supplement. Again, blood samples were taken at t=3 and t=5 hours, after which the subjects finished their intervention and were free to leave. All subjects undertook this intervention pattern twice, crossing over the aspirin and placebo supplements with a washout period of 14 days (minimum) in between. The minimum duration of the set of interventions was 30 days.
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Primary Outcome(s)
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Changes in platelet function in response to agonist, changes in platelet thromboxane generation and changes in PFA-100 closure time (time to form a primary clot) at t3 hours after supplementation
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Secondary Outcome(s)
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1. Changes in platelet-related parameters at t5 hours after supplementation
2. Changes in plasma clotting times at t3 and t5 hours after supplementation
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Secondary ID(s)
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08/S0802/196
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Source(s) of Monetary Support
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Investigator initiated and funded
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Ethics review
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Status:
Approval date:
Contact:
North of Scotland Research Ethics Committee (NOSRES), 14/01/2009, ref: 08/S0802/196
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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03/03/2010 |
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URL:
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