Effect of Cardio Mato (Grade A Lyc-O-Mato, a Tomato Extracted Lycopene) on Blood Pressure and Serum Lycopene, Phytofluene, and Phytoene Levels in Pre-hypertensive Otherwise Healthy Subjects
Inclusion Criteria:
1. Male and female subjects aged 18-65, both inclusive
2. Established Pre-hypertension defined as: Mean baseline SBP 130-139 mmHg and DBP of 89
mmHg or lower or SBP of 139 mmHg or lower and DBP of 85- 89 mmHg, at screening,
eligibility and randomization visits
3. Subjects that did not receive any antihypertensive treatment in the past o present
4. Subjects that are willing to sign an informed consent form prior to joining the study
Exclusion Criteria:
1. Subjects with Mean baseline SBP higher than 120 and lower than 130 mmHg
2. Subjects with Mean baseline DBP higher than 80 and lower than 85 mmHg
3. Subjects who are treated for blood pressure reduction (any treatment)
4. Subjects under treatment with other chronic medications (e.g. statins, NSAID etc.)
5. Subjects that use antioxidant agents or vitamins within 4 weeks prior to inclusion
into the study
6. Subjects that will not be able to follow the study dietary proscriptions from the
screening visit through the final visit
7. Subjects following any special diet including, but not limited to liquid, high or low
protein, raw food, vegetarian or vegan, etc
8. Subjects with known allergy to tomatoes, carotenoids, or vitamin E
9. Subjects diagnosed with Diabetes Mellitus
10. Subjects suffering from obesity
11. Subjects Suffering from a clinically significant dyslipidaemia
12. Subjects suffering from cardiac disease; e.g. suffering from cardiac angina, subjects
that were diagnosed with and MI, subjects that needed PTCA or CABG. Subjects
diagnosed with LVH, CHF or valvular heart disease
13. Subjects diagnosed with PVD
14. Subjects who were diagnosed with Cerebrovascular disease, s/p CVA, TIA
15. Subjects who suffer from any kind of kidney disease
16. Subjects who suffer from chronic liver disease; defined as elevated AST and ALT at
least by 2 times of the normal range
17. Subject with history or current use of illegal or "recreational" drugs
18. Subjects with a history of GI disease or surgery within 6 months prior to study
inclusion
19. Subjects with a history of malignancy in the past 5 years
20. Subjects with a history of autoimmune disease