Back to results

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

Primary Purpose

Prehypertension

Status

Completed

Phase

Not Applicable

Locations

Israel

Study Type

Interventional

Intervention

Cardio Mato

Placebo

About this trial

This is an interventional supportive care trial for Prehypertension focused on measuring Prehypertension, anti oxidation, lycopene

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Male and female subjects aged 18-65, both inclusive
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
Subjects that did not receive any antihypertensive treatment in the past o present
Subjects that are willing to sign an informed consent form prior to joining the study

Exclusion Criteria:

Subjects with Mean baseline SBP higher than 120 and lower than 130 mmHg
Subjects with Mean baseline DBP higher than 80 and lower than 85 mmHg
Subjects who are treated for blood pressure reduction (any treatment)
Subjects under treatment with other chronic medications (e.g. statins, NSAID etc.)
Subjects that use antioxidant agents or vitamins within 4 weeks prior to inclusion into the study
Subjects that will not be able to follow the study dietary proscriptions from the screening visit through the final visit
Subjects following any special diet including, but not limited to liquid, high or low protein, raw food, vegetarian or vegan, etc
Subjects with known allergy to tomatoes, carotenoids, or vitamin E
Subjects diagnosed with Diabetes Mellitus
Subjects suffering from obesity
Subjects Suffering from a clinically significant dyslipidaemia
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
Subjects diagnosed with PVD
Subjects who were diagnosed with Cerebrovascular disease, s/p CVA, TIA
Subjects who suffer from any kind of kidney disease
Subjects who suffer from chronic liver disease; defined as elevated AST and ALT at least by 2 times of the normal range
Subject with history or current use of illegal or "recreational" drugs
Subjects with a history of GI disease or surgery within 6 months prior to study inclusion
Subjects with a history of malignancy in the past 5 years
Subjects with a history of autoimmune disease

Sites / Locations

Maccabi Health care, outpatient clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Cardio Mato

Placebo

Arm Description

Soft gel capsule for oral use (Grade A Lyc-O-Mato, a tomato extracted lycopene)

Soft gel capsule without test material, for oral use

Outcomes

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

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

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

B.P change

Full Information

NCT ID

NCT01667510

First Posted

August 12, 2012

Last Updated

December 21, 2017

Sponsor

LycoRed Ltd.

Collaborators

Maccabi Healthcare Services, Israel

1. Study Identification

Unique Protocol Identification Number

NCT01667510

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2012

Overall Recruitment Status

Completed

Study Start Date

August 2012 (Actual)

Primary Completion Date

June 2013 (Actual)

Study Completion Date

August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

LycoRed Ltd.

Collaborators

Maccabi Healthcare Services, Israel

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prehypertension

Keywords

Prehypertension, anti oxidation, lycopene

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

80 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cardio Mato

Arm Type

Experimental

Arm Description

Soft gel capsule for oral use (Grade A Lyc-O-Mato, a tomato extracted lycopene)

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Soft gel capsule without test material, for oral use

Intervention Type

Dietary Supplement

Intervention Name(s)

Cardio Mato

Intervention Description

Soft gel capsule for oral use

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo

Intervention Description

Soft gel capsule without test material

Primary Outcome Measure Information:

Title

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

Description

Change in blood pressure from baseline to 12 weeks in mmHG

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

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

Description

Change in blood pressure from baseline to 4 and 8 weeks in mmHG

Time Frame

4-8 weeks

Title

The correlation between B.P changes in the Cardio Mato or placebo treatment arms during the study with serum lycopene phytofluene, and phytoene levels

Description

B.P change

Time Frame

12 weeks

Other Pre-specified Outcome Measures:

Title

Number of adverse events recorded during the supplementation period, lycopene compared to placebo

Description

AE epizoda

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male and female subjects aged 18-65, both inclusive 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 Subjects that did not receive any antihypertensive treatment in the past o present Subjects that are willing to sign an informed consent form prior to joining the study Exclusion Criteria: Subjects with Mean baseline SBP higher than 120 and lower than 130 mmHg Subjects with Mean baseline DBP higher than 80 and lower than 85 mmHg Subjects who are treated for blood pressure reduction (any treatment) Subjects under treatment with other chronic medications (e.g. statins, NSAID etc.) Subjects that use antioxidant agents or vitamins within 4 weeks prior to inclusion into the study Subjects that will not be able to follow the study dietary proscriptions from the screening visit through the final visit Subjects following any special diet including, but not limited to liquid, high or low protein, raw food, vegetarian or vegan, etc Subjects with known allergy to tomatoes, carotenoids, or vitamin E Subjects diagnosed with Diabetes Mellitus Subjects suffering from obesity Subjects Suffering from a clinically significant dyslipidaemia 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 Subjects diagnosed with PVD Subjects who were diagnosed with Cerebrovascular disease, s/p CVA, TIA Subjects who suffer from any kind of kidney disease Subjects who suffer from chronic liver disease; defined as elevated AST and ALT at least by 2 times of the normal range Subject with history or current use of illegal or "recreational" drugs Subjects with a history of GI disease or surgery within 6 months prior to study inclusion Subjects with a history of malignancy in the past 5 years Subjects with a history of autoimmune disease

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Arnon Aharon, MD.

Organizational Affiliation

LycoRed Ltd.

Official's Role

Study Director

Facility Information:

Facility Name

Maccabi Health care, outpatient clinic

City

Holon

ZIP/Postal Code

58361

Country

Israel

12. IPD Sharing Statement

Links:

URL

http://www.lycored.com

Description

Data on tomato extracted lycopene

Learn more about this trial

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

We'll reach out to this number within 24 hrs