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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01667510
Recruitment Status : Completed
First Posted : August 17, 2012
Last Update Posted : December 22, 2017
Maccabi Healthcare Services, Israel
Information provided by (Responsible Party):
LycoRed Ltd.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Prehypertension Dietary Supplement: Cardio Mato Dietary Supplement: Placebo Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
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
Actual Study Start Date : August 2012
Actual Primary Completion Date : June 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Lycopene

Arm Intervention/treatment
Experimental: Cardio Mato
Soft gel capsule for oral use (Grade A Lyc-O-Mato, a tomato extracted lycopene)
Dietary Supplement: Cardio Mato
Soft gel capsule for oral use

Placebo Comparator: Placebo
Soft gel capsule without test material, for oral use
Dietary Supplement: Placebo
Soft gel capsule without test material

Primary Outcome Measures :
  1. 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 [ Time Frame: 12 weeks ]
    Change in blood pressure from baseline to 12 weeks in mmHG

Secondary Outcome Measures :
  1. 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 [ Time Frame: 4-8 weeks ]
    Change in blood pressure from baseline to 4 and 8 weeks in mmHG

  2. The correlation between B.P changes in the Cardio Mato or placebo treatment arms during the study with serum lycopene phytofluene, and phytoene levels [ Time Frame: 12 weeks ]
    B.P change

Other Outcome Measures:
  1. Number of adverse events recorded during the supplementation period, lycopene compared to placebo [ Time Frame: 12 weeks ]
    AE epizoda

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01667510

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Maccabi Health care, outpatient clinic
Holon, Israel, 58361
Sponsors and Collaborators
LycoRed Ltd.
Maccabi Healthcare Services, Israel
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Study Director: Arnon Aharon, MD. LycoRed Ltd.

Additional Information:
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Responsible Party: LycoRed Ltd. Identifier: NCT01667510     History of Changes
Other Study ID Numbers: Lyc-2012-01
First Posted: August 17, 2012    Key Record Dates
Last Update Posted: December 22, 2017
Last Verified: August 2012

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by LycoRed Ltd.:
anti oxidation

Additional relevant MeSH terms:
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Vascular Diseases
Cardiovascular Diseases
Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Radiation-Protective Agents
Anticarcinogenic Agents
Antineoplastic Agents