Effect of Cardio Mato (Grade A Lyc-O-Mato, a Tomato Extracted Lycopene) on Blood Pressure

LycoRed

Status: Completed

Conditions: Prehypertension

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Cardio Mato

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01667510

Lyc-2012-01

Details and patient eligibility

About

The hypothesis of the study is that supplementation with Cardio Mato (a Tomato Extracted Lycopene)for 12 weeks will decrease the blood pressure of subjects with prehypertension compared to Placebo.

Full description

Blood-pressure reading of 140/90 mmHg (systolic/diastolic pressure) are typically regarded as having high blood pressure as defined in the most recent guidelines. From a physiological perspective, the regulation of blood pressure is a complicated process involving different biological systems and a number of feedback systems, including the nervous system, hormones, control of body fluid and regulators within the vessels themselves. In 90-95% of patients with high blood pressure the cause is unknown, whereas the remaining 5-10% may have secondary hypertension related to congenital heart defects, certain cancers or kidney abnormalities. Prehypertension [systolic blood pressure (SBP) 120-139 mm Hg, diastolic blood pressure (DBP) 80-89 mm Hg] is considered a precursor of hypertension and has been associated with an increased risk of up to 3.5 times in cardiovascular morbidity and mortality later in life.

According the report of the Joint National Committee on High Blood Pressure (JNC 7) and other international guidelines, weight control, reduced intake of salt and reduced alcohol consumption, as well as increase of potassium are recommend nutritional approaches to prevent and treat hypertension. In observational studies significant inverse association between high blood pressure and vegetarian diet rich in fibers, magnesium, potassium, calcium and protein have been reported. In addition various studies demonstrated the ability of antioxidant vitamins of natural origin to improve vascular function.

Enrollment: 80 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 2 patient groups, including a placebo group

Cardio Mato

Experimental group

Description:

Soft gel capsule for oral use (Grade A Lyc-O-Mato, a tomato extracted lycopene)

Treatment:

Dietary Supplement: Cardio Mato

Placebo

Placebo Comparator group

Description:

Soft gel capsule without test material, for oral use

Treatment:

Dietary Supplement: Placebo