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| Name | Class |
|---|---|
| Maccabi Healthcare Services, Israel | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cardio Mato | Experimental | Soft gel capsule for oral use (Grade A Lyc-O-Mato, a tomato extracted lycopene) |
|
| Placebo | Placebo Comparator | Soft gel capsule without test material, for oral use |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cardio Mato | Dietary Supplement | Soft gel capsule for oral use |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Change in blood pressure from baseline to 12 weeks in mmHG | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The effect Cardio Mato on the blood pressure of Pre-hypertensive otherwise healthy subjects compared to the placebo group following 4 and 8 weeks of treatment | Change in blood pressure from baseline to 4 and 8 weeks in mmHG | 4-8 weeks |
| The correlation between B.P changes in the Cardio Mato or placebo treatment arms during the study with serum lycopene phytofluene, and phytoene levels |
| Measure | Description | Time Frame |
|---|---|---|
| Number of adverse events recorded during the supplementation period, lycopene compared to placebo | AE epizoda | 12 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Arnon Aharon, MD. | LycoRed Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maccabi Health care, outpatient clinic | Holon | 58361 | Israel |
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| Label | URL |
|---|---|
| Data on tomato extracted lycopene | View source |
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| ID | Term |
|---|---|
| D058246 | Prehypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Placebo |
| Dietary Supplement |
Soft gel capsule without test material |
|
B.P change |
| 12 weeks |