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

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.

Study Overview

• Status: Completed
• Conditions: Prehypertension
• Intervention / Treatment: Dietary supplement: Cardio Mato; Dietary supplement: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Holon, Israel, 58361
    • Maccabi Health care, outpatient clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	B.P change	12 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of adverse events recorded during the supplementation period, lycopene compared to placebo	AE epizoda	12 weeks

Collaborators and Investigators

• Sponsor: LycoRed Ltd.
• Collaborators: Maccabi Healthcare Services, Israel
• Investigators: Study Director: Arnon Aharon, MD., LycoRed Ltd.

Publications and helpful links

Helpful Links

• Data on tomato extracted lycopene

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2012
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): August 1, 2013

Study Registration Dates

• First Submitted: August 12, 2012
• First Submitted That Met QC Criteria: August 15, 2012
• First Posted (Estimate): August 17, 2012

Study Record Updates

• Last Update Posted (Actual): December 22, 2017
• Last Update Submitted That Met QC Criteria: December 21, 2017
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Keywords: Prehypertension; lycopene; anti oxidation
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Prehypertension
• Other Study ID Numbers: Lyc-2012-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No