<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/NCT01692340</url>
  </required_header>
  <id_info>
    <org_study_id>OSU-09105</org_study_id>
    <secondary_id>NCI-2011-03180</secondary_id>
    <nct_id>NCT01692340</nct_id>
  </id_info>
  <brief_title>Novel 13C Carotenoids for Absorption and Metabolism Studies in Humans</brief_title>
  <official_title>Novel 13C Carotenoids for Absorption and Metabolism Studies in Humans.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ohio State University Comprehensive Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Illinois at Chicago</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Ohio State University Comprehensive Cancer Center</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Tomatoes contain several compounds which may be beneficial for human health and prevention of&#xD;
      disease, although this relationship is poorly understood and very controversial. This study&#xD;
      uses a new technology to study the absorption and metabolism of three different compounds&#xD;
      found in tomatoes. These compounds are called: phytoene, phytofluene, and lycopene. We&#xD;
      hypothesize that by studying the absorption and metabolism of these compounds, we may be able&#xD;
      to understand how the compounds may influence health and disease processes.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>February 2012</start_date>
  <completion_date type="Actual">November 2013</completion_date>
  <primary_completion_date type="Actual">November 2013</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Plasma Half Life of Labeled Carotenoid</measure>
    <time_frame>labelled lycopene: 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose. Labelled phytoene: hourly for hours 0 - 15, then hours 17, 19 and 21 hours after dosing. Then, 1, 2, 3 4, 7, 10, 14, 17, 21 and 28 days post dose.</time_frame>
    <description>We will study the half life of isotopically labeled carotenoids.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximal Plasma Carotenoid Concentration</measure>
    <time_frame>0 to 48 hours</time_frame>
    <description>We will determine the average maximal plasma carotenoid concentration in healthy volunteers</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Time of Maximal Carotenoid Concentration</measure>
    <time_frame>0 to 48 hours</time_frame>
    <description>We will determine when the maximal carotenoid concentration is achieved in the plasma</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Carotenoid Metabolites</measure>
    <time_frame>Up to 28 days</time_frame>
    <description>Study the metabolites produced from the labeled carotenoid in healthy subjects</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Isotopically labeled lycopene</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>We will administer 10 mg of isotopically labeled lycopene, phytoene or phytofluene mixed with olive oil and spread on an English muffin for consumption by participants.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Isotopically labeled phytoene</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>We will administer 3.2 mg isotopically labeled lycopene, phytoene or phytofluene mixed with olive oil and spread on an English muffin for consumption by participants.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Isotopically labeled phytofluene</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>We will administer 10 mg of isotopically labeled lycopene, phytoene or phytofluene mixed with olive oil and spread on an English muffin for consumption by participants.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Isotopically labeled lycopene, phytoene or phytofluene</intervention_name>
    <description>We will administer 10 mg of labeled carotenoid mixed with olive oil and spread on an English muffin for consumption by participants.</description>
    <arm_group_label>Isotopically labeled lycopene</arm_group_label>
    <arm_group_label>Isotopically labeled phytoene</arm_group_label>
    <arm_group_label>Isotopically labeled phytofluene</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Between ages of 21-70 years old.&#xD;
&#xD;
          -  Body mass index of between 18 and 27 kg/m2 (inclusive).&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG)performance status of O.&#xD;
&#xD;
          -  Not currently be taking carotenoid supplements&#xD;
&#xD;
          -  Have Blood Urea Nitrogen (BUN)/Creatinine (CR), liver enzymes, Complete Blood Count&#xD;
             (CBC), and Prothrombin time (PT/PTT/INR) within normal limits.&#xD;
&#xD;
          -  Have a hemoglobin level of at least 11 g /dL at the time of randomization.&#xD;
&#xD;
          -  Voluntarily agree to participate and sign an informed consent document.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Have a known allergy or intolerance to tomatoes.&#xD;
&#xD;
          -  Have a history of a nutrient malabsorption disease (such as celiac disease) or other&#xD;
             metabolic disorders requiring special diet recommendations.&#xD;
&#xD;
          -  Have uncontrolled hyperlipidemia (total cholesterol &gt; 200 mg/dL, LDL &gt; 160 mg/dL and&#xD;
             serum triglycerides &gt; 200 mg/dL) or lipidemia that may influence carotenoid&#xD;
             pharmacokinetics or transport.&#xD;
&#xD;
          -  Smoke tobacco products&#xD;
&#xD;
          -  Have a history of pituitary hormone diseases that currently require supplemental&#xD;
             hormonal administration (thyroid hormones, ACTH, growth hormone) or other endocrine&#xD;
             disorders requiring hormone administration with the exception of diabetes and&#xD;
             osteoporosis.&#xD;
&#xD;
          -  Are taking certain medications (prescription or over-the-counter) such as Orlistat,&#xD;
             which interfere with dietary fat absorption.&#xD;
&#xD;
          -  Are taking complementary and alternative medications that at the discretion of the&#xD;
             study physician Steven K. Clinton(SKC) may interfere with carotenoid absorption or&#xD;
             metabolism.&#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>Steven Clinton, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ohio State University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ohio State University Medical Center</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://cancer.osu.edu</url>
    <description>Jamesline</description>
  </link>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>September 20, 2012</study_first_submitted>
  <study_first_submitted_qc>September 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2012</study_first_posted>
  <results_first_submitted>February 10, 2015</results_first_submitted>
  <results_first_submitted_qc>September 4, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">October 7, 2015</results_first_posted>
  <last_update_submitted>March 12, 2019</last_update_submitted>
  <last_update_submitted_qc>March 12, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 26, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ohio State University Comprehensive Cancer Center</investigator_affiliation>
    <investigator_full_name>Steven Clinton</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>tomato</keyword>
  <keyword>prostate cancer</keyword>
  <keyword>metabolism</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lycopene</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>We completed the first two arms of the study with isotopically labelled lycopene and phytoene, however our funding was exhausted after the second arm and we did not complete the isotopically labelled phytofluene arm.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Isotopically Labeled Lycopene</title>
          <description>10.2 mg of labeled carotenoid with a controlled meal.&#xD;
Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism</description>
        </group>
        <group group_id="P2">
          <title>Isotopically Labeled Phytoene</title>
          <description>3.2 mg of labeled carotenoid with a controlled meal.&#xD;
Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism</description>
        </group>
        <group group_id="P3">
          <title>Istotopically Labeled Phytofluene</title>
          <description>10 mg of labeled carotenoid with a controlled meal.&#xD;
Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Healthy subjects (6 males and 6 females) between the age of 21-33 yo (inclusive).</population>
      <group_list>
        <group group_id="B1">
          <title>Isotopically Labeled Lycopene</title>
          <description>10.2 mg of labeled carotenoid with a controlled meal.&#xD;
Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism</description>
        </group>
        <group group_id="B2">
          <title>Isotopically Labeled Phytoene</title>
          <description>3.2 mg of labeled carotenoid with a controlled meal.&#xD;
Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism</description>
        </group>
        <group group_id="B3">
          <title>Isotopically Labeled Phytofluene</title>
          <description>10 mg of labeled carotenoid with a controlled meal.&#xD;
Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism</description>
        </group>
        <group group_id="B4">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="8"/>
            <count group_id="B2" value="4"/>
            <count group_id="B3" value="0"/>
            <count group_id="B4" value="12"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B4" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years old</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="24" lower_limit="21" upper_limit="31"/>
                    <measurement group_id="B2" value="27.7" lower_limit="21.9" upper_limit="32.3"/>
                    <measurement group_id="B4" value="25.3" lower_limit="21" upper_limit="32.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B4" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B4" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B4" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B4" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B4" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Plasma Half Life of Labeled Carotenoid</title>
        <description>We will study the half life of isotopically labeled carotenoids.</description>
        <time_frame>labelled lycopene: 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose. Labelled phytoene: hourly for hours 0 - 15, then hours 17, 19 and 21 hours after dosing. Then, 1, 2, 3 4, 7, 10, 14, 17, 21 and 28 days post dose.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Isotopically Labeled Lycopene</title>
            <description>10.2 mg of labeled carotenoid with a controlled meal.&#xD;
Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism</description>
          </group>
          <group group_id="O2">
            <title>Isotopically Labeled Phytoene</title>
            <description>3.2 mg of labeled carotenoid with a controlled meal.&#xD;
Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism</description>
          </group>
        </group_list>
        <measure>
          <title>Plasma Half Life of Labeled Carotenoid</title>
          <description>We will study the half life of isotopically labeled carotenoids.</description>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.2" spread="0.3"/>
                    <measurement group_id="O2" value="2.3" spread="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Carotenoid Metabolites</title>
        <description>Study the metabolites produced from the labeled carotenoid in healthy subjects</description>
        <time_frame>Up to 28 days</time_frame>
        <population>Due to funding issues, at present we have not analyzed these samples for carotenoid metabolites. We have frozen plasma and if funds become available we would consider anlayzing the samples for carotenoid metabolites.</population>
        <group_list>
          <group group_id="O1">
            <title>Isotopically Labeled Lycopene</title>
            <description>10 mg of labeled carotenoid with a controlled meal.&#xD;
Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism</description>
          </group>
          <group group_id="O2">
            <title>Isotopically Labeled Phytoene</title>
            <description>10 mg of labeled carotenoid with a controlled meal.&#xD;
Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism</description>
          </group>
        </group_list>
        <measure>
          <title>Carotenoid Metabolites</title>
          <description>Study the metabolites produced from the labeled carotenoid in healthy subjects</description>
          <population>Due to funding issues, at present we have not analyzed these samples for carotenoid metabolites. We have frozen plasma and if funds become available we would consider anlayzing the samples for carotenoid metabolites.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Maximal Plasma Carotenoid Concentration</title>
        <description>We will determine the average maximal plasma carotenoid concentration in healthy volunteers</description>
        <time_frame>0 to 48 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Isotopically Labeled Lycopene</title>
            <description>10 mg of labeled carotenoid with a controlled meal.&#xD;
Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism</description>
          </group>
          <group group_id="O2">
            <title>Isotopically Labeled Phytoene</title>
            <description>10 mg of labeled carotenoid with a controlled meal.&#xD;
Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism</description>
          </group>
        </group_list>
        <measure>
          <title>Maximal Plasma Carotenoid Concentration</title>
          <description>We will determine the average maximal plasma carotenoid concentration in healthy volunteers</description>
          <units>micromol</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.14" spread="0.02"/>
                    <measurement group_id="O2" value="0.056" spread="0.006"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Time of Maximal Carotenoid Concentration</title>
        <description>We will determine when the maximal carotenoid concentration is achieved in the plasma</description>
        <time_frame>0 to 48 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Isotopically Labeled Lycopene</title>
            <description>10 mg of labeled carotenoid with a controlled meal.&#xD;
Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism</description>
          </group>
          <group group_id="O2">
            <title>Isotopically Labeled Phytoene</title>
            <description>10 mg of labeled carotenoid with a controlled meal.&#xD;
Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism</description>
          </group>
          <group group_id="O3">
            <title>Isotopically Labeled Phytofluene</title>
            <description>10 mg of labeled carotenoid with a controlled meal.&#xD;
Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism</description>
          </group>
        </group_list>
        <measure>
          <title>Time of Maximal Carotenoid Concentration</title>
          <description>We will determine when the maximal carotenoid concentration is achieved in the plasma</description>
          <units>hours</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="4"/>
                <count group_id="O3" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30" spread="6"/>
                    <measurement group_id="O2" value="19.8" spread="9.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Isotopically Labeled Lycopene</title>
          <description>10.2 mg of labeled carotenoid with a controlled meal.&#xD;
Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism</description>
        </group>
        <group group_id="E2">
          <title>Isotopically Labeled Phytoene</title>
          <description>3.2 mg of labeled carotenoid with a controlled meal.&#xD;
Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Steven K. Clinton, MD PhD</name_or_title>
      <organization>The Ohio State University</organization>
      <phone>614-293-2886</phone>
      <email>steven.clinton@osumc.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01692340
org study id: OSU-09105
secondary id: NCI-2011-03180
nct id: NCT01692340
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Tomatoes contain several compounds which may be beneficial for human health and prevention of
      disease, although this relationship is poorly understood and very controversial. This study
      uses a new technology to study the absorption and metabolism of three different compounds
      found in tomatoes. These compounds are called: phytoene, phytofluene, and lycopene. We
      hypothesize that by studying the absorption and metabolism of these compounds, we may be able
      to understand how the compounds may influence health and disease processes.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Plasma Half Life of Labeled Carotenoid
time frame: labelled lycopene: 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose. Labelled phytoene: hourly for hours 0 - 15, then hours 17, 19 and 21 hours after dosing. Then, 1, 2, 3 4, 7, 10, 14, 17, 21 and 28 days post dose.
description: We will study the half life of isotopically labeled carotenoids.
measure: Maximal Plasma Carotenoid Concentration
time frame: 0 to 48 hours
description: We will determine the average maximal plasma carotenoid concentration in healthy volunteers
measure: Time of Maximal Carotenoid Concentration
time frame: 0 to 48 hours
description: We will determine when the maximal carotenoid concentration is achieved in the plasma
measure: Carotenoid Metabolites
time frame: Up to 28 days
description: Study the metabolites produced from the labeled carotenoid in healthy subjects
arm group label: Isotopically labeled lycopene
arm group type: Experimental
description: We will administer 10 mg of isotopically labeled lycopene, phytoene or phytofluene mixed with olive oil and spread on an English muffin for consumption by participants.
arm group label: Isotopically labeled phytoene
arm group type: Experimental
description: We will administer 3.2 mg isotopically labeled lycopene, phytoene or phytofluene mixed with olive oil and spread on an English muffin for consumption by participants.
arm group label: Isotopically labeled phytofluene
arm group type: Experimental
description: We will administer 10 mg of isotopically labeled lycopene, phytoene or phytofluene mixed with olive oil and spread on an English muffin for consumption by participants.
intervention type: Other
intervention name: Isotopically labeled lycopene, phytoene or phytofluene
description: We will administer 10 mg of labeled carotenoid mixed with olive oil and spread on an English muffin for consumption by participants.
arm group label: Isotopically labeled lycopene
arm group label: Isotopically labeled phytoene
arm group label: Isotopically labeled phytofluene
criteria: 
gender: All
minimum age: 21 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Steven Clinton, MD, PhD
role: Principal Investigator
affiliation: Ohio State University
facility: 
country: United States
url: http://cancer.osu.edu
description: Jamesline
responsible party type: Principal Investigator
investigator affiliation: Ohio State University Comprehensive Cancer Center
investigator full name: Steven Clinton
investigator title: Principal Investigator
mesh term: Lycopene
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 