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CompletedNCT01667510Updated Dec 22, 2017

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

An interventional study of Cardio Mato and Placebo in Prehypertension, sponsored by LycoRed Ltd.. Completed at 1 site in Israel. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-12-22.

Sponsored by LycoRed Ltd. · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Prehypertension

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Keywords

  • Prehypertension
  • anti oxidation
  • lycopene
03

In context

Prehypertension

145 studies on the registry are indexed under Prehypertension; 21 are open to participants now.

This study's enrollment of 80 is above the median of 62 across 127 interventional studies indexed under Prehypertension.

Browse Prehypertension studies →

Lead sponsor

LycoRed Ltd. is the lead sponsor of 9 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
80 participants (actual)

Study arms

  • Experimental
    Cardio Mato

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

    Dietary Supplement: Cardio Mato

  • Placebo comparator
    Placebo

    Soft gel capsule without test material, for oral use

    Dietary Supplement: Placebo

Interventions

  • Dietary supplementCardio Mato

    Soft gel capsule for oral use

  • Dietary supplementPlacebo

    Soft gel capsule without test material

06

What researchers measure

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

    Time frame: 12 weeks

Secondary outcomes

  1. 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

    Time frame: 4-8 weeks

  2. 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

    Time frame: 12 weeks

Other outcomes

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

    AE epizoda

    Time frame: 12 weeks

07

Study locations

1 site
  • Maccabi Health care, outpatient clinic
    Holon, 58361, Israel
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 22, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01667510
Lead sponsor
LycoRed Ltd.
Collaborators
Maccabi Healthcare Services, Israel
Responsible party
Sponsor
First posted
Aug 17, 2012
Start date
Aug 2012
Primary completion
Jun 2013
Completion
Aug 2013
Last update
Dec 22, 2017

Study contacts

Arnon Aharon, MD.
study director · LycoRed Ltd.

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2012. You cannot join it, but the record below documents what was studied.

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LycoRed Ltd.

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