Prehypertension Clinical Trial
Official title:
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
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.
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.
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