Effect of Cardio Mato (a Tomato Extracted Lycopene) on Blood Pressure and Serum Lycopene, Phytofluene, and Phytoene Levels in Pre-hypertensive Otherwise Healthy Subjects

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2012 by LycoRed Ltd.
Sponsor:
Collaborator:
Maccabi Healthcare Services, Israel
Information provided by (Responsible Party):
LycoRed Ltd.
ClinicalTrials.gov Identifier:
NCT01667510
First received: August 12, 2012
Last updated: August 15, 2012
Last verified: August 2012
  Purpose

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.

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 Intervention Phase
Prehypertension
Dietary Supplement: Cardio Mato (tomato extracted lycopene)
Dietary Supplement: Placebo
Phase 2

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

Resource links provided by NLM:


Further study details as provided by LycoRed Ltd.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Change in blood pressure from baseline to 12 weeks in mmHG


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Change in blood pressure from baseline to 4 and 8 weeks in mmHG

  • 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 ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Number of adverse events recorded during the supplementation period, lycopene compared to placebo [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 80
Study Start Date: August 2012
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cardio Mato (Grade A Lyc-O-Mato, a tomato extracted lycopene)
Soft gel capsule for oral use
Dietary Supplement: Cardio Mato (tomato extracted lycopene)
Soft gel capsule for oral use
Other Name: Grade A Lyc-O-Mato
Placebo Comparator: Placebo
Soft gel capsule without test material, for oral use
Dietary Supplement: Placebo
Soft gel capsule without test material

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01667510

Contacts
Contact: Arnon Aharon, MD. +972-54-5500702 arnon@rnd-is.com

Locations
Israel
Maccabi Health care, outpatient clinic Recruiting
Holon, Israel, 58361
Contact: Irene Radzinski, MD.    972-3-5001212    Radzinsk_i@mac.org.il   
Principal Investigator: Irene Radzinsk, MD.         
Sponsors and Collaborators
LycoRed Ltd.
Maccabi Healthcare Services, Israel
Investigators
Study Director: Arnon Aharon, MD. LycoRed Ltd.
  More Information

Additional Information:
No publications provided

Responsible Party: LycoRed Ltd.
ClinicalTrials.gov Identifier: NCT01667510     History of Changes
Other Study ID Numbers: Lyc-2012-01
Study First Received: August 12, 2012
Last Updated: August 15, 2012
Health Authority: Israel: Ministry of Health

Keywords provided by LycoRed Ltd.:
Prehypertension
anti oxidation
lycopene

Additional relevant MeSH terms:
Prehypertension
Vascular Diseases
Cardiovascular Diseases
Lycopene
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Radiation-Protective Agents
Anticarcinogenic Agents
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 23, 2014