Examination of platelet function and response to potentially beneficial dietary supplements in healthy subjects Not Applicable
Conditions
Interventions
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 ba
Sponsors
Provexis plc (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy subjects 2. Male and female 3. 45 - 75 years of age 4. Normal platelet function
Exclusion criteria
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
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| 1. Changes in platelet-related parameters at t5 hours after supplementation 2. Changes in plasma clotting times at t3 and t5 hours after supplementation | — |
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
United Kingdom
Outcome results
None listed