<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/NCT02233478</url>
  </required_header>
  <id_info>
    <org_study_id>14-000905</org_study_id>
    <nct_id>NCT02233478</nct_id>
  </id_info>
  <brief_title>Comparing the Effect of Whey and Soy Protein on the Absorption of Pomegranate Polyphenols in the Human Body</brief_title>
  <official_title>Dietary Protein in Pomegranate Ellagitannin Bioavailability</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, Los Angeles</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of California, Los Angeles</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is comparing the quantity of active metabolites from consuming pomegranate juice&#xD;
      in three different preparations. People who participate in this study will come in to the&#xD;
      Center for a screening visit, which includes a blood test and medical history. If you qualify&#xD;
      based on the screening visit, you will then come in to the Center while fasting in the&#xD;
      morning on three different days. You will eat a standardized breakfast and drink one of three&#xD;
      juices, and then remain for metabolic testing at the Center for a period of time after&#xD;
      eating. You will also be provided a standardized lunch and water during this period. Each of&#xD;
      those visits will last about 7 hours. During this time, and for the rest of the 24 hours&#xD;
      following drinking the juice, you will collect all of your urine. Following all three of&#xD;
      these 7-hour visits, you will return to the Center again the next day for a fasting blood&#xD;
      draw, drop off your urine sample, and pick up a new container to collect another 24 hour&#xD;
      urine sample. The following day, you will return to the Center to drop off your second urine&#xD;
      sample collection.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Pomegranate (Punica granatum L.) fruits are widely consumed as pomegranate juice (PJ), and&#xD;
      their health benefits have been studied extensively in animals and humans (1-6). The&#xD;
      pomegranate fruit is a rich source of polyphenols, most of which are ellagitannins (ETs).&#xD;
      Pomegranate extracts,which incorporate these major polyphenols from the pomegranate fruit,&#xD;
      have been developed in dry and liquid forms to provide alternative convenient sources for&#xD;
      obtaining the bioactive polyphenols found in PJ. We have previously reported on the&#xD;
      pharmacokinetics and metabolism of pomegranate polyphenols, after the consumption of PJ in&#xD;
      normal healthy human volunteers (7). In humans, ETs are converted to ellagic acid (EA) in the&#xD;
      small intestines and absorbed with a maximum plasma concentration observed at approximately 1&#xD;
      hour. EA disappears from plasma 6 hours after administration of PJ. Ellagitannins and ellagic&#xD;
      acid remaining in the intestine and are then further converted by gut microflora to&#xD;
      urolithin-A, absorbed and derivatives, which are metabolized by phase II enzymes and excreted&#xD;
      in human urine for up to 48 hours after consumption of PJ(7).&#xD;
&#xD;
      Polyphenols are dietary constituents of plants associated with health-promoting effects. In&#xD;
      the human diet, polyphenols are generally consumed in foods along with macronutrients.&#xD;
      Because the health benefits of polyphenols are critically determined by their&#xD;
      bioavailability, the effect of interactions between plant phenols and food macronutrients is&#xD;
      a very important topic. The protein-polyphenol complexes can significantly change the plasma&#xD;
      kinetics profile. (8) Protein-polyphenol binding is mediated by a combination of hydrogen and&#xD;
      hydrophobic bonding depending on chemical (polarity) and structural (size/shape) properties&#xD;
      of interacting molecules. Covalent interactions between purified glycinin, a soybean storage&#xD;
      protein, and selected flavonoids and phenolic acids have also been reported. Recently it is&#xD;
      reported that protein-rich defatted soybean flour protects anthocyanins during transit&#xD;
      through upper digestive tract for subsequent colonic delivery/metabolism (9).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">January 2015</completion_date>
  <primary_completion_date type="Actual">January 2015</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Plasma Ellagic Acid Concentration 0 to 24 Hours Post-dose Area Under the Curve</measure>
    <time_frame>Baseline, 0.5, 1, 2, 3, 4, 6 and 24 hr after 1 dosing of each intervention during the 3-week period</time_frame>
    <description>Blood samples were collected at baseline, 0.5, 1, 2, 3, 4, 6 and 24 h after ingestion of pomegranate juice (PJ) alone, or PJ mixed with soy protein, or PJ mixed with soybean flour. Plasma concentration of ellagic acid at each time point was determined to create a pharmacokinetic parameter area under the curve.</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">18</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Pomegranate Juice</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects will be asked to take a dietary supplement on the day of intervention. Prior to intervention, subjects will be asked to avoid high-polyphenol foods, certain vitamins, minerals, herbs and dietary supplements for 4 days, dietary instruction will be provided. Blood samples will be taken at screen for safety labs. On study days 5, 13 and 21 a spot urine will be collected and a 7 hr serial blood draw will be performed at 0 hr, 30 min, 1 hr, 2 hr, 3 hr, 4 hr and 6 hr. Subjects will be provided with a light lunch with foods low in polyphenols. Subjects will only be able to eat the foods provided on the intervention days. Subjects will be asked to drink 32oz of water during the 7-hr period. Subjects will also be asked to collect all of their urines for 24 hrs, 2 consecutive days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Soybean Flour Protein</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects will be asked to take a dietary supplement on the day of intervention. Prior to intervention, subjects will be asked to avoid high-polyphenol foods, certain vitamins, minerals, herbs and dietary supplements for 4 days, dietary instruction will be provided. Blood samples will be taken at screen for safety labs. On study days 5, 13 and 21 a spot urine will be collected and a 7 hr serial blood draw will be performed at 0 hr, 30 min, 1 hr, 2 hr, 3 hr, 4 hr and 6 hr. Subjects will be provided with a light lunch with foods low in polyphenols. Subjects will only be able to eat the foods provided on the intervention days. Subjects will be asked to drink 32oz of water during the 7-hr period. Subjects will also be asked to collect all of their urines for 24 hrs, 2 consecutive days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Soy Isolate Protein</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects will be asked to take a dietary supplement on the day of intervention. Prior to intervention, subjects will be asked to avoid high-polyphenol foods, certain vitamins, minerals, herbs and dietary supplements for 4 days, dietary instruction will be provided. Blood samples will be taken at screen for safety labs. On study days 5, 13 and 21 a spot urine will be collected and a 7 hr serial blood draw will be performed at 0 hr, 30 min, 1 hr, 2 hr, 3 hr, 4 hr and 6 hr. Subjects will be provided with a light lunch with foods low in polyphenols. Subjects will only be able to eat the foods provided on the intervention days. Subjects will be asked to drink 32oz of water during the 7-hr period. Subjects will also be asked to collect all of their urines for 24 hrs, 2 consecutive days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Pomegranate Juice</intervention_name>
    <description>Pomegranate Juice alone</description>
    <arm_group_label>Pomegranate Juice</arm_group_label>
    <arm_group_label>Soy Isolate Protein</arm_group_label>
    <arm_group_label>Soybean Flour Protein</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Soybean Flour Protein</intervention_name>
    <description>Soybean Flour Protein combined with Pomegranate Juice</description>
    <arm_group_label>Soybean Flour Protein</arm_group_label>
    <other_name>Nutrasorb</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Soy Isolate Protein</intervention_name>
    <description>Soy Isolate Protein combined with Pomegranate Juice</description>
    <arm_group_label>Soy Isolate Protein</arm_group_label>
    <other_name>Solae</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female &gt;20 and &lt; 45 years of age at the time the consent form is signed.&#xD;
&#xD;
          -  Subject must sign the Institutional Review Board-approved written informed consent&#xD;
             prior to the initiation of any study specific procedures or randomization. A subject&#xD;
             will be excluded for any condition that might compromise the ability to give truly&#xD;
             informed consent for participation in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any subject who is eating more than 4 servings per day of fruits and vegetables,&#xD;
             taking vitamin supplements or taking any antibiotics or other medication or dietary&#xD;
             supplement which interfere with the absorption of polyphenols.&#xD;
&#xD;
          -  Any subjects with a history of gastrointestinal surgery (except for appendectomy),&#xD;
             diabetes mellitus, or other serious medical condition, such as chronic hepatitis or&#xD;
             renal disease, bleeding disorder, congestive heart disease, chronic diarrhea&#xD;
             disorders, myocardial infarction, coronary artery bypass graft, angioplasty within 6&#xD;
             months prior to screening, current diagnosis of uncontrolled hypertension (defined as&#xD;
             BP &gt;160mmHg, diastolic BP&gt;95mmHg), active or chronic gastrointestinal disorders,&#xD;
             bulimia, anorexia, laxative abuse, or endocrine diseases (except thyroid disease&#xD;
             corrected with medication to normal laboratory values) as indicated by medical history&#xD;
             or routine physical examination.&#xD;
&#xD;
          -  Major surgery within 12 weeks prior to subject randomization and/or screening,&#xD;
             especially cardiac surgery&#xD;
&#xD;
          -  Is currently a smoker who has a therapeutic plan to quit smoking anytime during the&#xD;
             study period; or if not a current smoker, has quit smoking within the past 3 months.&#xD;
&#xD;
          -  Known HIV positive.&#xD;
&#xD;
          -  Clinical evidence of current malignancy with the exception of basal cell or squamous&#xD;
             cell carcinoma of the skin and cervical intraepithelial neoplasia.&#xD;
&#xD;
          -  Currently receiving systemic chemotherapy and/or radiotherapy.&#xD;
&#xD;
          -  Active bleeding.&#xD;
&#xD;
          -  Subject has any disorder (excluding illiteracy or visual impairment) that compromises&#xD;
             the ability of the subject to give written informed consent and/or to comply with&#xD;
             study procedures.&#xD;
&#xD;
          -  Subject who is allergic to soy protein.&#xD;
&#xD;
          -  In the opinion of the study investigator has a risk of non-compliance with study&#xD;
             procedures, or can not read, understand or complete study related materials.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Zhaoping Li, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UCLA Department of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UCLA Center for Human Nutrition</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>August 15, 2014</study_first_submitted>
  <study_first_submitted_qc>September 3, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 8, 2014</study_first_posted>
  <results_first_submitted>September 25, 2018</results_first_submitted>
  <results_first_submitted_qc>August 15, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">September 19, 2019</results_first_posted>
  <last_update_submitted>August 15, 2019</last_update_submitted>
  <last_update_submitted_qc>August 15, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 19, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of California, Los Angeles</investigator_affiliation>
    <investigator_full_name>Zhaoping Li</investigator_full_name>
    <investigator_title>Professor of Medicine and Chief Division of Clinical Nutrition</investigator_title>
  </responsible_party>
  <keyword>Pomegranate polyphenols</keyword>
  <keyword>Soy Protein</keyword>
  <keyword>Ellagitannins</keyword>

  <clinical_results>

    <participant_flow>
      <recruitment_details>The enrollment period was 08/01/2014 - 01/31/2015. Enrollment took place in a private setting in the clinic located at the site.</recruitment_details>
      <pre_assignment_details>After a 4-day washout period, participants received pomegranate juice (PJ) alone, PJ mixed with soy protein, or PJ mixed with soybean flour in random sequence with a 7-day washout in between.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>PJ First, Then PJ With Soybean Flour, Then PJ With Soy Protein</title>
          <description>Participants consumed PJ alone, then PJ+ soybean flour, then PJ + soy protein with PJ dosing 236.5 mL, soy protein 20 g and soybean flour 20 g</description>
        </group>
        <group group_id="P2">
          <title>PJ First, Then PJ With Soy Protein, Then PJ With Soybean Flour</title>
          <description>Participants consumed PJ alone, then PJ+ soy protein, then PJ + soybean flour with PJ dosing 236.5 mL, soy protein 20 g and soybean flour 20 g</description>
        </group>
        <group group_id="P3">
          <title>PJ With Soybean Flour First, Then PJ, Then PJ With Soy Protein</title>
          <description>Participants consumed PJ+soybean flour, then PJ alone, then PJ+soy protein with PJ dosing 236.5 mL, soy protein 20 g and soybean flour 20 g</description>
        </group>
        <group group_id="P4">
          <title>PJ With Soybean Flour First, Then PJ With Soy Protein, Then PJ</title>
          <description>Participants consumed PJ+soybean flour, then PJ+soy protein, then PJ alone with PJ dosing 236.5 mL, soy protein 20 g and soybean flour 20 g</description>
        </group>
        <group group_id="P5">
          <title>PJ With Soy Protein First, Then PJ With Soybean Flour, Then PJ</title>
          <description>Participants consumed PJ+soy protein, then PJ+soybean flour, then PJ alone with PJ dosing 236.5 mL, soy protein 20 g and soybean flour 20 g</description>
        </group>
        <group group_id="P6">
          <title>PJ With Soy Protein First, Then PJ, Then PJ With Soybean Flour</title>
          <description>Participants consumed PJ+soy protein, then PJ alone, then PJ+soybean flour with PJ dosing 236.5 mL, soy protein 20 g and soybean flour 20 g</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>First Intervention (1 Day)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="3"/>
                <participants group_id="P4" count="3"/>
                <participants group_id="P5" count="3"/>
                <participants group_id="P6" count="3"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="3"/>
                <participants group_id="P4" count="3"/>
                <participants group_id="P5" count="3"/>
                <participants group_id="P6" count="3"/>
              </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 group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Washout (7 Days)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="3"/>
                <participants group_id="P4" count="3"/>
                <participants group_id="P5" count="3"/>
                <participants group_id="P6" count="3"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="3"/>
                <participants group_id="P4" count="3"/>
                <participants group_id="P5" count="3"/>
                <participants group_id="P6" count="3"/>
              </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 group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Second Intervention (1 Day)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="3"/>
                <participants group_id="P4" count="3"/>
                <participants group_id="P5" count="3"/>
                <participants group_id="P6" count="3"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="3"/>
                <participants group_id="P4" count="3"/>
                <participants group_id="P5" count="3"/>
                <participants group_id="P6" count="3"/>
              </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 group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Washout (7 Days)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="3"/>
                <participants group_id="P4" count="3"/>
                <participants group_id="P5" count="3"/>
                <participants group_id="P6" count="3"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="3"/>
                <participants group_id="P4" count="3"/>
                <participants group_id="P5" count="3"/>
                <participants group_id="P6" count="3"/>
              </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 group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Third Intervention (1 Day)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="3"/>
                <participants group_id="P4" count="3"/>
                <participants group_id="P5" count="3"/>
                <participants group_id="P6" count="3"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="3"/>
                <participants group_id="P4" count="3"/>
                <participants group_id="P5" count="3"/>
                <participants group_id="P6" count="3"/>
              </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 group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Since this was a crossover study, the total number of participants was 18 in each arm.</population>
      <group_list>
        <group group_id="B1">
          <title>All Study Participants</title>
          <description>Participants took pomegranate juice (PJ, 236.5 mL or 8 fl.oz) alone, or PJ (236.5 mL) mixed with 20 g of soy protein, or PJ (236.5 mL) mixed with 20 g of soybean flour in random order.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="18"/>
          </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_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <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="31.1" spread="7.0"/>
                  </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="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </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_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" 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="18"/>
                  </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="26.3" spread="6.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Plasma Ellagic Acid Concentration 0 to 24 Hours Post-dose Area Under the Curve</title>
        <description>Blood samples were collected at baseline, 0.5, 1, 2, 3, 4, 6 and 24 h after ingestion of pomegranate juice (PJ) alone, or PJ mixed with soy protein, or PJ mixed with soybean flour. Plasma concentration of ellagic acid at each time point was determined to create a pharmacokinetic parameter area under the curve.</description>
        <time_frame>Baseline, 0.5, 1, 2, 3, 4, 6 and 24 hr after 1 dosing of each intervention during the 3-week period</time_frame>
        <population>All participants for whom plasma ellagic acid was determined at baseline, 0.5, 1, 2, 3, 4, 6 and 24 hr after 1 dosing of PJ, or PJ with soy protein, or PJ with soybean flour</population>
        <group_list>
          <group group_id="O1">
            <title>All Study Participants Consuming PJ</title>
            <description>Participants consumed PJ (236.5 mL) only</description>
          </group>
          <group group_id="O2">
            <title>All Study Participants Comsuming PJ With Soy Protein</title>
            <description>Participants consumed PJ (236.5 mL) mixed with soy protein isolate (20 g)</description>
          </group>
          <group group_id="O3">
            <title>All Study Participants Comsuming PJ With Soybean Flour</title>
            <description>Participants consumed PJ (236.5 mL) with soybean flour protein (20 g)</description>
          </group>
        </group_list>
        <measure>
          <title>Plasma Ellagic Acid Concentration 0 to 24 Hours Post-dose Area Under the Curve</title>
          <description>Blood samples were collected at baseline, 0.5, 1, 2, 3, 4, 6 and 24 h after ingestion of pomegranate juice (PJ) alone, or PJ mixed with soy protein, or PJ mixed with soybean flour. Plasma concentration of ellagic acid at each time point was determined to create a pharmacokinetic parameter area under the curve.</description>
          <population>All participants for whom plasma ellagic acid was determined at baseline, 0.5, 1, 2, 3, 4, 6 and 24 hr after 1 dosing of PJ, or PJ with soy protein, or PJ with soybean flour</population>
          <units>micromol*h/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="18"/>
                <count group_id="O3" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.074" spread="0.029"/>
                    <measurement group_id="O2" value="0.075" spread="0.028"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Comparison of ellagic acid concentration 0 to 24 hours post-dose area under the curve was made to PJ alone vs. PJ with soy protein after intervention.&#xD;
Due to the quality issue of soybean flour, data from this intervention group was not analyzed.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.82</p_value>
            <method>t-test, 2 sided</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.001</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse data was collected over a 3 week period</time_frame>
      <desc>Participants were monitored and questioned regarding the occurrence and nature of any adverse experiences.</desc>
      <group_list>
        <group group_id="E1">
          <title>Study Participants Consuming PJ Alone</title>
          <description>All participants consumed PJ (236.5 mL or 8 fl.oz) alone</description>
        </group>
        <group group_id="E2">
          <title>Study Participants Consuming PJ With Soy Protein</title>
          <description>All participants consumed PJ (236.5 mL) mixed with 20 g of soy protein</description>
        </group>
        <group group_id="E3">
          <title>Study Participants Consuming PJ With Soybean Flour</title>
          <description>All participants consumed PJ (236.5 mL) mixed with 20 g of soybean flour</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="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
              </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="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
              </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>Zhaoping Li, Professor</name_or_title>
      <organization>Center for Human Nutrition, Department of Medicine, UCLA David Geffen School of Medicine</organization>
      <phone>310-206-1987 ext 61987</phone>
      <email>zli@mednet.ucla.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/NCT02233478
org study id: 14-000905
nct id: NCT02233478
lead sponsor: 
has dmc: No
This study is comparing the quantity of active metabolites from consuming pomegranate juice
      in three different preparations. People who participate in this study will come in to the
      Center for a screening visit, which includes a blood test and medical history. If you qualify
      based on the screening visit, you will then come in to the Center while fasting in the
      morning on three different days. You will eat a standardized breakfast and drink one of three
      juices, and then remain for metabolic testing at the Center for a period of time after
      eating. You will also be provided a standardized lunch and water during this period. Each of
      those visits will last about 7 hours. During this time, and for the rest of the 24 hours
      following drinking the juice, you will collect all of your urine. Following all three of
      these 7-hour visits, you will return to the Center again the next day for a fasting blood
      draw, drop off your urine sample, and pick up a new container to collect another 24 hour
      urine sample. The following day, you will return to the Center to drop off your second urine
      sample collection.
Pomegranate (Punica granatum L.) fruits are widely consumed as pomegranate juice (PJ), and
      their health benefits have been studied extensively in animals and humans (1-6). The
      pomegranate fruit is a rich source of polyphenols, most of which are ellagitannins (ETs).
      Pomegranate extracts,which incorporate these major polyphenols from the pomegranate fruit,
      have been developed in dry and liquid forms to provide alternative convenient sources for
      obtaining the bioactive polyphenols found in PJ. We have previously reported on the
      pharmacokinetics and metabolism of pomegranate polyphenols, after the consumption of PJ in
      normal healthy human volunteers (7). In humans, ETs are converted to ellagic acid (EA) in the
      small intestines and absorbed with a maximum plasma concentration observed at approximately 1
      hour. EA disappears from plasma 6 hours after administration of PJ. Ellagitannins and ellagic
      acid remaining in the intestine and are then further converted by gut microflora to
      urolithin-A, absorbed and derivatives, which are metabolized by phase II enzymes and excreted
      in human urine for up to 48 hours after consumption of PJ(7).

      Polyphenols are dietary constituents of plants associated with health-promoting effects. In
      the human diet, polyphenols are generally consumed in foods along with macronutrients.
      Because the health benefits of polyphenols are critically determined by their
      bioavailability, the effect of interactions between plant phenols and food macronutrients is
      a very important topic. The protein-polyphenol complexes can significantly change the plasma
      kinetics profile. (8) Protein-polyphenol binding is mediated by a combination of hydrogen and
      hydrophobic bonding depending on chemical (polarity) and structural (size/shape) properties
      of interacting molecules. Covalent interactions between purified glycinin, a soybean storage
      protein, and selected flavonoids and phenolic acids have also been reported. Recently it is
      reported that protein-rich defatted soybean flour protects anthocyanins during transit
      through upper digestive tract for subsequent colonic delivery/metabolism (9).
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Single (Participant)
measure: Plasma Ellagic Acid Concentration 0 to 24 Hours Post-dose Area Under the Curve
time frame: Baseline, 0.5, 1, 2, 3, 4, 6 and 24 hr after 1 dosing of each intervention during the 3-week period
description: Blood samples were collected at baseline, 0.5, 1, 2, 3, 4, 6 and 24 h after ingestion of pomegranate juice (PJ) alone, or PJ mixed with soy protein, or PJ mixed with soybean flour. Plasma concentration of ellagic acid at each time point was determined to create a pharmacokinetic parameter area under the curve.
arm group label: Pomegranate Juice
arm group type: Active Comparator
description: Subjects will be asked to take a dietary supplement on the day of intervention. Prior to intervention, subjects will be asked to avoid high-polyphenol foods, certain vitamins, minerals, herbs and dietary supplements for 4 days, dietary instruction will be provided. Blood samples will be taken at screen for safety labs. On study days 5, 13 and 21 a spot urine will be collected and a 7 hr serial blood draw will be performed at 0 hr, 30 min, 1 hr, 2 hr, 3 hr, 4 hr and 6 hr. Subjects will be provided with a light lunch with foods low in polyphenols. Subjects will only be able to eat the foods provided on the intervention days. Subjects will be asked to drink 32oz of water during the 7-hr period. Subjects will also be asked to collect all of their urines for 24 hrs, 2 consecutive days.
arm group label: Soybean Flour Protein
arm group type: Active Comparator
description: Subjects will be asked to take a dietary supplement on the day of intervention. Prior to intervention, subjects will be asked to avoid high-polyphenol foods, certain vitamins, minerals, herbs and dietary supplements for 4 days, dietary instruction will be provided. Blood samples will be taken at screen for safety labs. On study days 5, 13 and 21 a spot urine will be collected and a 7 hr serial blood draw will be performed at 0 hr, 30 min, 1 hr, 2 hr, 3 hr, 4 hr and 6 hr. Subjects will be provided with a light lunch with foods low in polyphenols. Subjects will only be able to eat the foods provided on the intervention days. Subjects will be asked to drink 32oz of water during the 7-hr period. Subjects will also be asked to collect all of their urines for 24 hrs, 2 consecutive days.
arm group label: Soy Isolate Protein
arm group type: Active Comparator
description: Subjects will be asked to take a dietary supplement on the day of intervention. Prior to intervention, subjects will be asked to avoid high-polyphenol foods, certain vitamins, minerals, herbs and dietary supplements for 4 days, dietary instruction will be provided. Blood samples will be taken at screen for safety labs. On study days 5, 13 and 21 a spot urine will be collected and a 7 hr serial blood draw will be performed at 0 hr, 30 min, 1 hr, 2 hr, 3 hr, 4 hr and 6 hr. Subjects will be provided with a light lunch with foods low in polyphenols. Subjects will only be able to eat the foods provided on the intervention days. Subjects will be asked to drink 32oz of water during the 7-hr period. Subjects will also be asked to collect all of their urines for 24 hrs, 2 consecutive days.
intervention type: Dietary Supplement
intervention name: Pomegranate Juice
description: Pomegranate Juice alone
arm group label: Pomegranate Juice
arm group label: Soy Isolate Protein
arm group label: Soybean Flour Protein
intervention type: Dietary Supplement
intervention name: Soybean Flour Protein
description: Soybean Flour Protein combined with Pomegranate Juice
arm group label: Soybean Flour Protein
other name: Nutrasorb
intervention type: Dietary Supplement
intervention name: Soy Isolate Protein
description: Soy Isolate Protein combined with Pomegranate Juice
arm group label: Soy Isolate Protein
other name: Solae
criteria: 
gender: All
minimum age: 20 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Zhaoping Li, MD, PhD
role: Principal Investigator
affiliation: UCLA Department of Medicine
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of California, Los Angeles
investigator full name: Zhaoping Li
investigator title: Professor of Medicine and Chief Division of Clinical Nutrition
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 