<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/NCT01696773</url>
  </required_header>
  <id_info>
    <org_study_id>2012H0189</org_study_id>
    <nct_id>NCT01696773</nct_id>
  </id_info>
  <brief_title>Carotenoid and Flavonoid Absorption From Red and Tangerine-Type Tomatoes</brief_title>
  <official_title>Enhancing Bioavailability and Nutritional Quality of Processed Tomato Products</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ohio State University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ohio State University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Eating a diet rich in tomatoes has been associated with decreased risk for a variety of&#xD;
      diseases. Tomatoes contain red-colored lycopene (one type of pigment in the class of pigments&#xD;
      called carotenoids), which has been associated with the decreased risk of disease in those&#xD;
      consuming tomato products; however, tomatoes also contain flavonoids, which may also have&#xD;
      health promoting effects. The Tangerine tomato, a unique tomato variety, contains lycopene in&#xD;
      a different form that in red tomatoes and this contributes to their characteristic orange&#xD;
      color. This &quot;orange lycopene&quot; is more similar to the most common form of lycopene found in&#xD;
      the blood and tissue of people who eat a tomato-rich diet, and may be more easily absorbed by&#xD;
      the body.&#xD;
&#xD;
      The objectives of this study are to determine if carotenoids and flavonoids from Tangerine&#xD;
      tomatoes are more easily absorbed by the body than red tomatoes, and to examine if eating&#xD;
      Tangerine versus red tomatoes impacts markers of inflammation (response to harmful substances&#xD;
      by the body).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary goal of this research is to determine if a processed Tangerine tomato product has&#xD;
      enhanced bioavailability of carotenoids and flavonoids compared to a commercially available&#xD;
      processed red tomato product in humans. This primary objective will be accomplished by&#xD;
      quantifying carotenoids from post-prandial triglyceride-rich lipoprotein (TRL) fractions of&#xD;
      plasma and flavonoids from whole plasma and urine, after subjects consume a meal containing&#xD;
      Tangerine or red tomato juice. A secondary goal is to examine if short-term delivery of&#xD;
      bioactives from Tangerine and red tomatoes impact markers of inflammation in humans. This&#xD;
      secondary objective will be accomplished by analyzing plasma for both interleukin-6 (IL-6), a&#xD;
      marker for inflammation, and RNA to assess alterations in transcription of genes that&#xD;
      regulate inflammation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Anticipated">December 2024</completion_date>
  <primary_completion_date type="Actual">September 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>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pharmacokinetics of Carotenoid Absorption</measure>
    <time_frame>11 post-prandial blood samples will be taken over 12 hours</time_frame>
    <description>The primary goal of this research is to determine if a processed tangerine tomato product has enhanced bioavailability of carotenoids and flavonoids compared to a commercially available processed red tomato product in humans. An area under the curve for concentration of carotenoids (from triglyceride rich lipoprotein (TRL) fraction of plasma) by using carotenoid concentrations from hours 0, 2, 3, 4, 5, 6, 8, 10 and 12 over time to quantify absorption, after subjects consume a meal containing tangerine or red tomato juice.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Carotenoid and Flavonoid Absorption</condition>
  <arm_group>
    <arm_group_label>Tangerine tomato juice</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Tangerine tomato juice will be fed</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Red tomato juice</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Red tomato juice will be fed</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Tangerine tomato juice</intervention_name>
    <description>Post-prandial feeding study</description>
    <arm_group_label>Tangerine tomato juice</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Red tomato juice</intervention_name>
    <description>Post-prandial feeding study</description>
    <arm_group_label>Red tomato juice</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Total cholesterol ≤200 mg/dL&#xD;
&#xD;
          -  Triglycerides ≤ 200mg/dL&#xD;
&#xD;
          -  BMI 18.5 to 30.0kg/m2&#xD;
&#xD;
          -  Not anemic (hemoglobin at or above 10g/dL and hematocrit at or above 30%)&#xD;
&#xD;
          -  Age 18-70 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Lactating, pregnant, or plan to be pregnant during study&#xD;
&#xD;
          -  Tobacco (cigarettes and chewing tobacco)&#xD;
&#xD;
          -  Metabolic disease, such as diabetes mellitus or thyroid dysfunction&#xD;
&#xD;
          -  Malabsorption disorders (e.g. ileus, Crohn's, ulcerative colitis, pancreatic&#xD;
             insufficiency)&#xD;
&#xD;
          -  History of cancer, esophageal, gastric, or intestinal ulcers&#xD;
&#xD;
          -  History of liver or kidney insufficiency or failure&#xD;
&#xD;
          -  Auto-immune disorders&#xD;
&#xD;
          -  Chronic inflammation (e.g. rheumatoid arthritis)&#xD;
&#xD;
          -  Allergies to tomatoes or tomato products&#xD;
&#xD;
          -  Obesity (BMI &gt; 30kg/m2) or underweight (BMI &lt;18.5kg/m2)&#xD;
&#xD;
          -  Hypercholesterolemia (Total cholesterol &gt; 200 mg/dL)&#xD;
&#xD;
          -  Triglycerides &gt; 200mg/dL&#xD;
&#xD;
          -  Subjects taking non-steroidal anti-inflammatory medications (e.g. Aspirin, Advil,&#xD;
             Tylenol, Aleve) for 72 hours prior to each day-long visit.&#xD;
&#xD;
          -  Anemia (hemoglobin below 10g/dL or hematocrit below 30%)&#xD;
&#xD;
          -  Blood donation within the last 8 weeks&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Steven J Schwartz, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ohio State University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Ohio State University Clinical Research 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>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>September 27, 2012</study_first_submitted>
  <study_first_submitted_qc>September 28, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 1, 2012</study_first_posted>
  <results_first_submitted>October 14, 2014</results_first_submitted>
  <results_first_submitted_qc>October 20, 2014</results_first_submitted_qc>
  <results_first_posted type="Estimate">October 24, 2014</results_first_posted>
  <last_update_submitted>September 19, 2022</last_update_submitted>
  <last_update_submitted_qc>September 19, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 29, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ohio State University</investigator_affiliation>
    <investigator_full_name>Jessica Cooperstone</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>tomato</keyword>
  <keyword>tangerine tomato</keyword>
  <keyword>carotenoids</keyword>
  <keyword>lycopene</keyword>
  <keyword>flavonoids</keyword>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Tangerine Tomato Juice First, Then Red Tomato Juice</title>
          <description>Tangerine tomato juice will be fed, followed by a 14 day washout, and then red tomato juice will be fed</description>
        </group>
        <group group_id="P2">
          <title>Red Tomato Juice First, Then Tangerine Tomato Juice</title>
          <description>Red tomato juice will be fed, followed by a 14 day washout, then tangerine tomato juice will be fed.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Days 1-13, Washout</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Day 14, First Intervention</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Days 15-27, Washout</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Day 28, Second Intervention</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Tangerine Tomato Juice First, Then Red Tomato Juice</title>
          <description>Tangerine tomato juice is consumed on day 14 then red tomato juice on day 28</description>
        </group>
        <group group_id="B2">
          <title>Red Tomato Juice First, Then Tangerine Tomato Juice</title>
          <description>Red tomato juice is consumed on day 14, then tangerine tomato juice on day 28</description>
        </group>
        <group group_id="B3">
          <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="6"/>
            <count group_id="B2" value="6"/>
            <count group_id="B3" value="12"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="22.8" spread="2.8"/>
                    <measurement group_id="B2" value="29.0" spread="13.4"/>
                    <measurement group_id="B3" value="25.9" spread="9.8"/>
                  </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="3"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="6"/>
                  </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="6"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>BMI</title>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="23.1" spread="1.4"/>
                    <measurement group_id="B2" value="25.5" spread="1.6"/>
                    <measurement group_id="B3" value="23.3" spread="1.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Plasma cholesterol (mg/dL)</title>
          <units>mg/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="170.6" spread="8.9"/>
                    <measurement group_id="B2" value="176.2" spread="12.5"/>
                    <measurement group_id="B3" value="173.8" spread="10.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Plasma triglycerides (mg/dL)</title>
          <units>mg/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="65.8" spread="49.3"/>
                    <measurement group_id="B2" value="85.8" spread="42.3"/>
                    <measurement group_id="B3" value="75.8" spread="45.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Hematocrit</title>
          <units>Volume % of red blood cells in blood</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="41.8" spread="2.8"/>
                    <measurement group_id="B2" value="42.0" spread="3.8"/>
                    <measurement group_id="B3" value="41.9" spread="3.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Hemoglobin</title>
          <units>g/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13.9" spread="0.8"/>
                    <measurement group_id="B2" value="14.1" spread="1.1"/>
                    <measurement group_id="B3" value="14.0" spread="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Pharmacokinetics of Carotenoid Absorption</title>
        <description>The primary goal of this research is to determine if a processed tangerine tomato product has enhanced bioavailability of carotenoids and flavonoids compared to a commercially available processed red tomato product in humans. An area under the curve for concentration of carotenoids (from triglyceride rich lipoprotein (TRL) fraction of plasma) by using carotenoid concentrations from hours 0, 2, 3, 4, 5, 6, 8, 10 and 12 over time to quantify absorption, after subjects consume a meal containing tangerine or red tomato juice.</description>
        <time_frame>11 post-prandial blood samples will be taken over 12 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Tangerine Tomato Juice</title>
            <description>Tangerine tomato juice will be fed&#xD;
Tangerine tomato juice: Post-prandial feeding study</description>
          </group>
          <group group_id="O2">
            <title>Red Tomato Juice</title>
            <description>Red tomato juice will be fed&#xD;
Red tomato juice: Post-prandial feeding study</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetics of Carotenoid Absorption</title>
          <description>The primary goal of this research is to determine if a processed tangerine tomato product has enhanced bioavailability of carotenoids and flavonoids compared to a commercially available processed red tomato product in humans. An area under the curve for concentration of carotenoids (from triglyceride rich lipoprotein (TRL) fraction of plasma) by using carotenoid concentrations from hours 0, 2, 3, 4, 5, 6, 8, 10 and 12 over time to quantify absorption, after subjects consume a meal containing tangerine or red tomato juice.</description>
          <units>nmol*h/L</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
                <count group_id="O2" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="690.9" spread="117.8"/>
                    <measurement group_id="O2" value="81.6" spread="32.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Tangerine Tomato Juice</title>
          <description>Tangerine tomato juice will be fed&#xD;
Tangerine tomato juice: Post-prandial feeding study</description>
        </group>
        <group group_id="E2">
          <title>Red Tomato Juice</title>
          <description>Red tomato juice will be fed&#xD;
Red tomato juice: Post-prandial feeding study</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="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</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="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Menstrual distress</sub_title>
                <description>1 subject chose to dropout of the study 4 days after the first day long visit (at day 18). Adverse event categorized as sexual/reproductive function - other, menstrual distress - mild to moderate, not attributable or associated with the study agent.</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT 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 J. Schwartz</name_or_title>
      <organization>The Ohio State University</organization>
      <phone>614-292-2934</phone>
      <email>schwartz.177@osu.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/NCT01696773
org study id: 2012H0189
nct id: NCT01696773
lead sponsor: 
has dmc: Yes
Eating a diet rich in tomatoes has been associated with decreased risk for a variety of
      diseases. Tomatoes contain red-colored lycopene (one type of pigment in the class of pigments
      called carotenoids), which has been associated with the decreased risk of disease in those
      consuming tomato products; however, tomatoes also contain flavonoids, which may also have
      health promoting effects. The Tangerine tomato, a unique tomato variety, contains lycopene in
      a different form that in red tomatoes and this contributes to their characteristic orange
      color. This "orange lycopene" is more similar to the most common form of lycopene found in
      the blood and tissue of people who eat a tomato-rich diet, and may be more easily absorbed by
      the body.

      The objectives of this study are to determine if carotenoids and flavonoids from Tangerine
      tomatoes are more easily absorbed by the body than red tomatoes, and to examine if eating
      Tangerine versus red tomatoes impacts markers of inflammation (response to harmful substances
      by the body).
The primary goal of this research is to determine if a processed Tangerine tomato product has
      enhanced bioavailability of carotenoids and flavonoids compared to a commercially available
      processed red tomato product in humans. This primary objective will be accomplished by
      quantifying carotenoids from post-prandial triglyceride-rich lipoprotein (TRL) fractions of
      plasma and flavonoids from whole plasma and urine, after subjects consume a meal containing
      Tangerine or red tomato juice. A secondary goal is to examine if short-term delivery of
      bioactives from Tangerine and red tomatoes impact markers of inflammation in humans. This
      secondary objective will be accomplished by analyzing plasma for both interleukin-6 (IL-6), a
      marker for inflammation, and RNA to assess alterations in transcription of genes that
      regulate inflammation.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Pharmacokinetics of Carotenoid Absorption
time frame: 11 post-prandial blood samples will be taken over 12 hours
description: The primary goal of this research is to determine if a processed tangerine tomato product has enhanced bioavailability of carotenoids and flavonoids compared to a commercially available processed red tomato product in humans. An area under the curve for concentration of carotenoids (from triglyceride rich lipoprotein (TRL) fraction of plasma) by using carotenoid concentrations from hours 0, 2, 3, 4, 5, 6, 8, 10 and 12 over time to quantify absorption, after subjects consume a meal containing tangerine or red tomato juice.
arm group label: Tangerine tomato juice
arm group type: Experimental
description: Tangerine tomato juice will be fed
arm group label: Red tomato juice
arm group type: Experimental
description: Red tomato juice will be fed
intervention type: Other
intervention name: Tangerine tomato juice
description: Post-prandial feeding study
arm group label: Tangerine tomato juice
intervention type: Other
intervention name: Red tomato juice
description: Post-prandial feeding study
arm group label: Red tomato juice
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Steven J Schwartz, Ph.D.
role: Principal Investigator
affiliation: Ohio State University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Ohio State University
investigator full name: Jessica Cooperstone
investigator title: Assistant Professor
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 