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

NCT ID: NCT01667510

Last Updated: 2017-12-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2013-08-31

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.

Conditions

Prehypertension

Keywords

Prehypertension; anti oxidation; lycopene

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

Cardio Mato

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

Group Type: EXPERIMENTAL

Cardio Mato

Intervention Type: DIETARY_SUPPLEMENT

Soft gel capsule for oral use

Placebo

Soft gel capsule without test material, for oral use

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Soft gel capsule without test material

Interventions

Cardio Mato

Soft gel capsule for oral use

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Soft gel capsule without test material

Intervention Type: DIETARY_SUPPLEMENT

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Maccabi Healthcare Services, Israel

OTHER

Sponsor Role: collaborator

LycoRed Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Arnon Aharon, MD.

Role: STUDY_DIRECTOR

LycoRed Ltd.

Locations

Maccabi Health care, outpatient clinic

Holon, , Israel

Countries

Israel

Related Links

http://www.lycored.com

Data on tomato extracted lycopene

Other Identifiers

Lyc-2012-01

Identifier Type: -

Identifier Source: org_study_id