<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01667510</url>
  </required_header>
  <id_info>
    <org_study_id>Lyc-2012-01</org_study_id>
    <nct_id>NCT01667510</nct_id>
  </id_info>
  <brief_title>Effect of Cardio Mato (Grade A Lyc-O-Mato, a Tomato Extracted Lycopene) on Blood Pressure</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>LycoRed Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Maccabi Healthcare Services, Israel</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>LycoRed Ltd.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The hypothesis of the study is that supplementation with Cardio Mato (a Tomato Extracted&#xD;
      Lycopene)for 12 weeks will decrease the blood pressure of subjects with prehypertension&#xD;
      compared to Placebo.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Blood-pressure reading of 140/90 mmHg (systolic/diastolic pressure) are typically regarded as&#xD;
      having high blood pressure as defined in the most recent guidelines. From a physiological&#xD;
      perspective, the regulation of blood pressure is a complicated process involving different&#xD;
      biological systems and a number of feedback systems, including the nervous system, hormones,&#xD;
      control of body fluid and regulators within the vessels themselves. In 90-95% of patients&#xD;
      with high blood pressure the cause is unknown, whereas the remaining 5-10% may have secondary&#xD;
      hypertension related to congenital heart defects, certain cancers or kidney abnormalities.&#xD;
      Prehypertension [systolic blood pressure (SBP) 120-139 mm Hg, diastolic blood pressure (DBP)&#xD;
      80-89 mm Hg] is considered a precursor of hypertension and has been associated with an&#xD;
      increased risk of up to 3.5 times in cardiovascular morbidity and mortality later in life.&#xD;
&#xD;
      According the report of the Joint National Committee on High Blood Pressure (JNC 7) and other&#xD;
      international guidelines, weight control, reduced intake of salt and reduced alcohol&#xD;
      consumption, as well as increase of potassium are recommend nutritional approaches to prevent&#xD;
      and treat hypertension. In observational studies significant inverse association between high&#xD;
      blood pressure and vegetarian diet rich in fibers, magnesium, potassium, calcium and protein&#xD;
      have been reported. In addition various studies demonstrated the ability of antioxidant&#xD;
      vitamins of natural origin to improve vascular function.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 2012</start_date>
  <completion_date type="Actual">August 2013</completion_date>
  <primary_completion_date type="Actual">June 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>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</measure>
    <time_frame>12 weeks</time_frame>
    <description>Change in blood pressure from baseline to 12 weeks in mmHG</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>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</measure>
    <time_frame>4-8 weeks</time_frame>
    <description>Change in blood pressure from baseline to 4 and 8 weeks in mmHG</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The correlation between B.P changes in the Cardio Mato or placebo treatment arms during the study with serum lycopene phytofluene, and phytoene levels</measure>
    <time_frame>12 weeks</time_frame>
    <description>B.P change</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Number of adverse events recorded during the supplementation period, lycopene compared to placebo</measure>
    <time_frame>12 weeks</time_frame>
    <description>AE epizoda</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Prehypertension</condition>
  <arm_group>
    <arm_group_label>Cardio Mato</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Soft gel capsule for oral use (Grade A Lyc-O-Mato, a tomato extracted lycopene)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Soft gel capsule without test material, for oral use</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Cardio Mato</intervention_name>
    <description>Soft gel capsule for oral use</description>
    <arm_group_label>Cardio Mato</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Soft gel capsule without test material</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male and female subjects aged 18-65, both inclusive&#xD;
&#xD;
          2. Established Pre-hypertension defined as: Mean baseline SBP 130-139 mmHg and DBP of 89&#xD;
             mmHg or lower or SBP of 139 mmHg or lower and DBP of 85- 89 mmHg, at screening,&#xD;
             eligibility and randomization visits&#xD;
&#xD;
          3. Subjects that did not receive any antihypertensive treatment in the past o present&#xD;
&#xD;
          4. Subjects that are willing to sign an informed consent form prior to joining the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subjects with Mean baseline SBP higher than 120 and lower than 130 mmHg&#xD;
&#xD;
          2. Subjects with Mean baseline DBP higher than 80 and lower than 85 mmHg&#xD;
&#xD;
          3. Subjects who are treated for blood pressure reduction (any treatment)&#xD;
&#xD;
          4. Subjects under treatment with other chronic medications (e.g. statins, NSAID etc.)&#xD;
&#xD;
          5. Subjects that use antioxidant agents or vitamins within 4 weeks prior to inclusion&#xD;
             into the study&#xD;
&#xD;
          6. Subjects that will not be able to follow the study dietary proscriptions from the&#xD;
             screening visit through the final visit&#xD;
&#xD;
          7. Subjects following any special diet including, but not limited to liquid, high or low&#xD;
             protein, raw food, vegetarian or vegan, etc&#xD;
&#xD;
          8. Subjects with known allergy to tomatoes, carotenoids, or vitamin E&#xD;
&#xD;
          9. Subjects diagnosed with Diabetes Mellitus&#xD;
&#xD;
         10. Subjects suffering from obesity&#xD;
&#xD;
         11. Subjects Suffering from a clinically significant dyslipidaemia&#xD;
&#xD;
         12. Subjects suffering from cardiac disease; e.g. suffering from cardiac angina, subjects&#xD;
             that were diagnosed with and MI, subjects that needed PTCA or CABG. Subjects diagnosed&#xD;
             with LVH, CHF or valvular heart disease&#xD;
&#xD;
         13. Subjects diagnosed with PVD&#xD;
&#xD;
         14. Subjects who were diagnosed with Cerebrovascular disease, s/p CVA, TIA&#xD;
&#xD;
         15. Subjects who suffer from any kind of kidney disease&#xD;
&#xD;
         16. Subjects who suffer from chronic liver disease; defined as elevated AST and ALT at&#xD;
             least by 2 times of the normal range&#xD;
&#xD;
         17. Subject with history or current use of illegal or &quot;recreational&quot; drugs&#xD;
&#xD;
         18. Subjects with a history of GI disease or surgery within 6 months prior to study&#xD;
             inclusion&#xD;
&#xD;
         19. Subjects with a history of malignancy in the past 5 years&#xD;
&#xD;
         20. Subjects with a history of autoimmune disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Arnon Aharon, MD.</last_name>
    <role>Study Director</role>
    <affiliation>LycoRed Ltd.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Maccabi Health care, outpatient clinic</name>
      <address>
        <city>Holon</city>
        <zip>58361</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <link>
    <url>http://www.lycored.com</url>
    <description>Data on tomato extracted lycopene</description>
  </link>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 12, 2012</study_first_submitted>
  <study_first_submitted_qc>August 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 17, 2012</study_first_posted>
  <last_update_submitted>December 21, 2017</last_update_submitted>
  <last_update_submitted_qc>December 21, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">December 22, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Prehypertension</keyword>
  <keyword>anti oxidation</keyword>
  <keyword>lycopene</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prehypertension</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01667510
org study id: Lyc-2012-01
nct id: NCT01667510
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: 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
time frame: 12 weeks
description: Change in blood pressure from baseline to 12 weeks in mmHG
measure: 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
time frame: 4-8 weeks
description: Change in blood pressure from baseline to 4 and 8 weeks in mmHG
measure: The correlation between B.P changes in the Cardio Mato or placebo treatment arms during the study with serum lycopene phytofluene, and phytoene levels
time frame: 12 weeks
description: B.P change
measure: Number of adverse events recorded during the supplementation period, lycopene compared to placebo
time frame: 12 weeks
description: AE epizoda
arm group label: Cardio Mato
arm group type: Experimental
description: Soft gel capsule for oral use (Grade A Lyc-O-Mato, a tomato extracted lycopene)
arm group label: Placebo
arm group type: Placebo Comparator
description: Soft gel capsule without test material, for oral use
intervention type: Dietary Supplement
intervention name: Cardio Mato
description: Soft gel capsule for oral use
arm group label: Cardio Mato
intervention type: Dietary Supplement
intervention name: Placebo
description: Soft gel capsule without test material
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Arnon Aharon, MD.
role: Study Director
affiliation: LycoRed Ltd.
facility: 
country: Israel
url: http://www.lycored.com
description: Data on tomato extracted lycopene
responsible party type: Sponsor
mesh term: Prehypertension