<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/NCT01665469</url>
  </required_header>
  <id_info>
    <org_study_id>Lyc-2012-02</org_study_id>
    <nct_id>NCT01665469</nct_id>
  </id_info>
  <brief_title>Effect of Tomato Extracted Lycopene on Postprandial Oxidation and inﬂammation in Healthy Weight Men and Women</brief_title>
  <official_title>Effect of Tomato Extracted Lycopene on Postprandial Oxidation and inﬂammation in Healthy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>LycoRed Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </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 tomato extracted lycopene will be able to decrease&#xD;
      postprandial oxidation and inﬂammation in healthy weight men and women when compared to&#xD;
      Placebo.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Consumption of a high-fat meal results in a postprandial (fed-state) response characterized&#xD;
      by hypertriglyceridemia. Postprandial hypertriglyceridemia increases the oxidation of&#xD;
      low-density lipoproteins (LDL) and increases blood concentrations of several biomarkers of&#xD;
      inﬂammation. This postprandial lipemia-induced oxidative stress mediated response to a&#xD;
      high-fat meal has been suggested as a major contributor to the pathogenesis of&#xD;
      atherosclerosis along with other chronic disease states of diabetes and obesity. Consumption&#xD;
      of foods rich in antioxidant compounds provides a defence source to compliment endogenous&#xD;
      defence systems to protect against oxidative damage during pro-oxidant conditions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2012</start_date>
  <completion_date type="Actual">June 2013</completion_date>
  <primary_completion_date type="Actual">April 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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Reduction of postprandial Oxidized LDL(OX-LDL) levels following 2 weeks of supplementation with tomato extracted lycopene</measure>
    <time_frame>Baseline and over 6 hours</time_frame>
    <description>Following two weeks of supplementation the evaluation will be done at baseline,before the high fat meal and during 6 hours following the meal.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Reduction of postprandial triglycerides, glucose, insulin and hsCRP levels following 2 weeks of supplementation with tomato extracted lycopene</measure>
    <time_frame>Baseline and over 6 hours</time_frame>
    <description>Following two weeks of supplementation the evaluation will be done at baseline,before the high fat meal and during 6 hours following the meal.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Correlation between the anti-oxidation and anti-inﬂammation effects and serum lycopene, phytofluene and phytoene levels</measure>
    <time_frame>Baseline and over 6 hours</time_frame>
    <description>Following two weeks of supplementation the evaluation will be done at baseline,before the high fat meal and during 6 hours following the meal.</description>
  </other_outcome>
  <other_outcome>
    <measure>Number of adverse events recorded during the supplementation period, lycopene compared to placebo</measure>
    <time_frame>2 weeks</time_frame>
    <description>safety measurements</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Postprandial Oxidation and inﬂammation</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Soft gel capsule without test material</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Tomato extracted lycopene</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Soft gel cups for oral use</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Tomato extracted lycopene</intervention_name>
    <arm_group_label>Tomato extracted lycopene</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female&#xD;
&#xD;
          2. Age: 21 - 70 years both inclusive&#xD;
&#xD;
          3. Subject with Body Mass Index: 19- 25 kg/m2 both inclusive&#xD;
&#xD;
          4. Subject with Fasting serum LDL-cholesterol: ≥ 100 mg/dL and &lt; 200 mg/dL&#xD;
&#xD;
          5. Subject with High-sensitivity C-reactive protein (hsCRP) &lt; 1.0 mg/L&#xD;
&#xD;
          6. Subject is willing to take supplement once daily for 4 weeks and undergo other&#xD;
             study-related procedures&#xD;
&#xD;
          7. Subject is otherwise is in general good health as determined by the principal&#xD;
             investigator&#xD;
&#xD;
          8. Subjects is willing to sign an informed consent form prior to joining the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subjects suffering from overweight defined as BMI &gt; 25 kg/m2&#xD;
&#xD;
          2. Subject that is actively losing weight (e.g. are on a diet) or subjects with greater&#xD;
             than 5% change in body weight within 1 month prior to the randomization visit&#xD;
&#xD;
          3. Subject taking lipid-altering drug therapy within six weeks prior to screening. Also&#xD;
             excluded are supplements known to have significant lipid altering effects, such as&#xD;
             niacin, garlic, omega-3 fatty acids, red yeast rice extract, phytostanols /&#xD;
             phytosterols, soluble fiber, chitosan and conjugated linoleic acid&#xD;
&#xD;
          4. Subjects using the following medications: systemic corticosteroids, orlistat, bile&#xD;
             acid resins, prescription omega-3 fatty acids, cyclical or non-continuous hormone&#xD;
             therapy&#xD;
&#xD;
          5. Subjects that use antioxidant agents or vitamins within 6 weeks prior to inclusion&#xD;
             into the study. For subject using vitamin supplementation a 6 week wash out will be&#xD;
             required prior to inclusion into the study.&#xD;
&#xD;
          6. Subjects that will not be able to follow dietary proscriptions from the screening&#xD;
             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 tomato, carotenoids, or vitamin E&#xD;
&#xD;
          9. Subjects that smoke (past smokers are allowed if smoking was ceased &gt; 2 years prior to&#xD;
             study inclusion)&#xD;
&#xD;
         10. Subjects that has high fasting serum triglyceride&#xD;
&#xD;
         11. Subjects that has a diagnosis of type 1 or type 2 diabetes mellitus&#xD;
&#xD;
         12. Subjects that has high serum thyroid-stimulating hormone&#xD;
&#xD;
         13. Subjects that has aspartate aminotransferase (AST) or alanine transaminase (ALT) &gt; 3&#xD;
             times the upper limit of normal&#xD;
&#xD;
         14. Subjects that has Creatinine ≥ 1.5 mg/dl&#xD;
&#xD;
         15. Subjects that has high-sensitivity C-reactive protein&#xD;
&#xD;
         16. Woman subjects with positive pregnancy test&#xD;
&#xD;
         17. Woman subjects that are breast feeding, pregnant, or planning on becoming pregnant&#xD;
             during the duration of the study&#xD;
&#xD;
         18. Subjects with known cardiovascular disease or stroke, except for conditions that are&#xD;
             deemed clinically insignificant by Principle Investigator or Sub-investigator, or&#xD;
             study site physician (e.g. clinically insignificant atherosclerotic lesions observed&#xD;
             by imaging studies).&#xD;
&#xD;
         19. Subject with history of significant gastrointestinal disease such as severe&#xD;
             constipation, diarrhea, malabsorptive disease, inflammatory bowel disease (e.g.&#xD;
             Crohn's disease, ulcerative colitis)&#xD;
&#xD;
         20. Subject with history of severe psychiatric illness which in the opinion of the&#xD;
             investigator would interfere with the optimal participation in the study&#xD;
&#xD;
         21. Subject with history of bariatric surgery&#xD;
&#xD;
         22. Subject with history or current use of illegal or &quot;recreational&quot; drugs&#xD;
&#xD;
         23. Subject that used any investigational drug(s) 60 days prior to screening&#xD;
&#xD;
         24. Subject that participate in any other clinical trial while participating in this trial&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David Zeltser, Prof'</last_name>
    <role>Principal Investigator</role>
    <affiliation>Tel Aviv Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Tel Aviv Sourasky Medical Center</name>
      <address>
        <city>Tel-Aviv</city>
        <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>December 2017</verification_date>
  <study_first_submitted>August 9, 2012</study_first_submitted>
  <study_first_submitted_qc>August 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 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>anti oxidation</keyword>
  <keyword>lycopene</keyword>
  <keyword>Ox-LDL</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Inflammation</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lycopene</mesh_term>
  </intervention_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/NCT01665469
org study id: Lyc-2012-02
nct id: NCT01665469
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The hypothesis of the study is that tomato extracted lycopene will be able to decrease
      postprandial oxidation and inﬂammation in healthy weight men and women when compared to
      Placebo.
Consumption of a high-fat meal results in a postprandial (fed-state) response characterized
      by hypertriglyceridemia. Postprandial hypertriglyceridemia increases the oxidation of
      low-density lipoproteins (LDL) and increases blood concentrations of several biomarkers of
      inﬂammation. This postprandial lipemia-induced oxidative stress mediated response to a
      high-fat meal has been suggested as a major contributor to the pathogenesis of
      atherosclerosis along with other chronic disease states of diabetes and obesity. Consumption
      of foods rich in antioxidant compounds provides a defence source to compliment endogenous
      defence systems to protect against oxidative damage during pro-oxidant conditions.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Reduction of postprandial Oxidized LDL(OX-LDL) levels following 2 weeks of supplementation with tomato extracted lycopene
time frame: Baseline and over 6 hours
description: Following two weeks of supplementation the evaluation will be done at baseline,before the high fat meal and during 6 hours following the meal.
measure: Reduction of postprandial triglycerides, glucose, insulin and hsCRP levels following 2 weeks of supplementation with tomato extracted lycopene
time frame: Baseline and over 6 hours
description: Following two weeks of supplementation the evaluation will be done at baseline,before the high fat meal and during 6 hours following the meal.
measure: Correlation between the anti-oxidation and anti-inﬂammation effects and serum lycopene, phytofluene and phytoene levels
time frame: Baseline and over 6 hours
description: Following two weeks of supplementation the evaluation will be done at baseline,before the high fat meal and during 6 hours following the meal.
measure: Number of adverse events recorded during the supplementation period, lycopene compared to placebo
time frame: 2 weeks
description: safety measurements
arm group label: Placebo
arm group type: Placebo Comparator
description: Soft gel capsule without test material
arm group label: Tomato extracted lycopene
arm group type: Experimental
description: Soft gel cups for oral use
intervention type: Dietary Supplement
intervention name: Tomato extracted lycopene
arm group label: Tomato extracted lycopene
intervention type: Dietary Supplement
intervention name: Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 21 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: David Zeltser, Prof'
role: Principal Investigator
affiliation: Tel Aviv Medical Center
facility: 
country: Israel
url: http://www.lycored.com
description: Data on tomato extracted lycopene
responsible party type: Sponsor
mesh term: Inflammation
mesh term: Lycopene