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

NCT01667510 | Completed

• 1 other identifier: Lyc-2012-01
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Prehypertension

Keywords

Prehypertension; anti oxidation; lycopene

Outcome Measures

Primary Outcomes (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

  Change in blood pressure from baseline to 12 weeks in mmHG

  12 weeks

Secondary Outcomes (2)

• 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

  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

  12 weeks

Other Outcomes (1)

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

  12 weeks

Study Arms (2)

Cardio Mato

EXPERIMENTAL

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

Dietary Supplement: Cardio Mato

Placebo

PLACEBO COMPARATOR

Soft gel capsule without test material, for oral use

Dietary Supplement: Placebo

Interventions

Cardio Mato DIETARY_SUPPLEMENT

Soft gel capsule for oral use

Cardio Mato

Placebo DIETARY_SUPPLEMENT

Soft gel capsule without test material

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 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

Sponsors & Collaborators

• LycoRed Ltd.: lead
• Maccabi Healthcare Services, Israel: collaborator

Study Sites (1)

Maccabi Health care, outpatient clinic

Holon, 58361, Israel

Location

Related Links

• Data on tomato extracted lycopene

MeSH Terms

Conditions

Prehypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Arnon Aharon, MD.

  LycoRed Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2012
• First Posted: August 17, 2012
• Study Start: August 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: August 1, 2013
• Last Updated: December 22, 2017

Record last verified: 2012-08

Locations

IL (1)