<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/NCT01713829</url>
  </required_header>
  <id_info>
    <org_study_id>CB-472-2012</org_study_id>
    <nct_id>NCT01713829</nct_id>
  </id_info>
  <brief_title>Cranberry Consumption Improves γδ T Cell Function</brief_title>
  <official_title>Cranberry Consumption Improves γδ T Cell Function</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Florida</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Cranberry Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Florida</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine the extent to which consuming a cranberry beverage&#xD;
      modifies immune function, specifically related to γδ T cells and other innate immune cells.&#xD;
      It is hypothesized that cranberry components will interact with immune cells to activate&#xD;
      signaling pathways that enhance cell function. Enhanced immune cell function should result in&#xD;
      reduced number, duration, and severity of cold and flu symptoms.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">August 2013</completion_date>
  <primary_completion_date type="Actual">January 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Immune Cell Function</measure>
    <time_frame>Measured at baseline and 6 weeks</time_frame>
    <description>Change in leukocyte phenotype&#xD;
Change in the ability of the natural killer and/or γδ T cells to proliferate when cultured ex vivo&#xD;
Change in peripheral blood mononuclear cell cytokine and chemokine production in response to mitogens</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cold and Flu Symptoms</measure>
    <time_frame>12 weeks</time_frame>
    <description>Incidence and severity of cold and flu symptoms, total and individual. Other signs of severity, for example, visits to doctor or health clinic, reduction in daily activities, prescribed or over-the-counter medications taken.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">52</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Cranberry Beverage</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cranberry Beverage is provided in an 8 oz daily beverage consumed once daily for 12 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo Beverage</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>The placebo beverage looks like the active arm and is given in the same way but contains no active ingredient.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Cranberry Beverage</intervention_name>
    <description>8 oz cranberry beverage consumed daily for 12 weeks</description>
    <arm_group_label>Cranberry Beverage</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo Beverage</intervention_name>
    <description>8 oz placebo beverage consumed daily for 12 weeks</description>
    <arm_group_label>Placebo Beverage</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  between 21 and 35 years of age and in good health&#xD;
&#xD;
          -  have a BMI between 18.5 and 29.9&#xD;
&#xD;
          -  willing to consume the study beverage for 12 weeks&#xD;
&#xD;
          -  willing to have a small amount of blood drawn two times&#xD;
&#xD;
          -  willing to stop consuming tea and immune-enhancing dietary supplements (e.g.&#xD;
             antioxidant-, probiotic-, or flavonoid-containing supplements, fish oil, and&#xD;
             Echinacea) before and during the 12 weeks of the study&#xD;
&#xD;
          -  willing to consume no more than 7 servings of fruits and vegetables a day&#xD;
&#xD;
          -  willing to limit your alcohol consumption to no more than 14 glasses a week&#xD;
&#xD;
          -  willing to limit your yogurt consumption to no more than one 8oz. serving per day&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  have food allergies&#xD;
&#xD;
          -  have hypertension&#xD;
&#xD;
          -  taking non-steroidal anti-inflammatory drugs on a chronic basis, antibiotics, or&#xD;
             immunosuppressive drugs&#xD;
&#xD;
          -  sensitive to aspirin or prone to kidney stones&#xD;
&#xD;
          -  current smoker&#xD;
&#xD;
          -  pregnant, lactating, or on hormone therapy, except for birth control pills&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Susan S Percival, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Florida</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>449 Food Science and Human Nutrition Department, University of Florida</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2014</verification_date>
  <study_first_submitted>September 18, 2012</study_first_submitted>
  <study_first_submitted_qc>October 22, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 25, 2012</study_first_posted>
  <last_update_submitted>January 10, 2014</last_update_submitted>
  <last_update_submitted_qc>January 10, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 14, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>cranberry</keyword>
  <keyword>gamma delta T cell</keyword>
  <keyword>improvement in immune cell function in healthy humans</keyword>
  <keyword>proliferation</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01713829
org study id: CB-472-2012
nct id: NCT01713829
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to determine the extent to which consuming a cranberry beverage
      modifies immune function, specifically related to γδ T cells and other innate immune cells.
      It is hypothesized that cranberry components will interact with immune cells to activate
      signaling pathways that enhance cell function. Enhanced immune cell function should result in
      reduced number, duration, and severity of cold and flu symptoms.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change in Immune Cell Function
time frame: Measured at baseline and 6 weeks
description: Change in leukocyte phenotype
Change in the ability of the natural killer and/or γδ T cells to proliferate when cultured ex vivo
Change in peripheral blood mononuclear cell cytokine and chemokine production in response to mitogens
measure: Cold and Flu Symptoms
time frame: 12 weeks
description: Incidence and severity of cold and flu symptoms, total and individual. Other signs of severity, for example, visits to doctor or health clinic, reduction in daily activities, prescribed or over-the-counter medications taken.
arm group label: Cranberry Beverage
arm group type: Experimental
description: Cranberry Beverage is provided in an 8 oz daily beverage consumed once daily for 12 weeks
arm group label: Placebo Beverage
arm group type: Placebo Comparator
description: The placebo beverage looks like the active arm and is given in the same way but contains no active ingredient.
intervention type: Other
intervention name: Cranberry Beverage
description: 8 oz cranberry beverage consumed daily for 12 weeks
arm group label: Cranberry Beverage
intervention type: Other
intervention name: Placebo Beverage
description: 8 oz placebo beverage consumed daily for 12 weeks
arm group label: Placebo Beverage
criteria: 
gender: All
minimum age: 21 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Susan S Percival, PhD
role: Principal Investigator
affiliation: University of Florida
facility: 
country: United States
responsible party type: Sponsor