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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


Phase 2
18 Years
65 Years
Open (Enrolling)
Both
Prehypertension

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Trial Information

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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

The effect Lyc-O-Mato on the blood pressure of pre-hypertensive otherwise healthy subjects compared to the placebo group following 12 weeks of treatment

Outcome Description:

Change in blood pressure from baseline to 12 weeks in mmHG

Outcome Time Frame:

12 weeks

Safety Issue:

No

Principal Investigator

Arnon Aharon, MD.

Investigator Role:

Study Director

Investigator Affiliation:

LycoRed Ltd.

Authority:

Israel: Ministry of Health

Study ID:

Lyc-2012-01

NCT ID:

NCT01667510

Start Date:

August 2012

Completion Date:

August 2013

Related Keywords:

  • Prehypertension
  • Prehypertension
  • anti oxidation
  • lycopene
  • Prehypertension

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