<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/NCT02210234</url>
  </required_header>
  <id_info>
    <org_study_id>114-2010</org_study_id>
    <nct_id>NCT02210234</nct_id>
  </id_info>
  <brief_title>Wheat Bioactives and Immune Function</brief_title>
  <official_title>Wheat Bioactives and Immune Function</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Florida</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Kellogg's Corporate Citizens Fund</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Florida</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this research was to understand the effects of bioactive compounds found in&#xD;
      wheat cereal on human immunity. Subjects came in for a baseline blood draw, consumed whole&#xD;
      wheat bran cereal daily for 21 days, and returned for a final blood draw. Immune function&#xD;
      assays were performed at both sampling times. It was predicted that eating wheat bran would&#xD;
      benefit immune function.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Healthy individuals, between 18 and 50 years of age, were recruited by flyer and word of&#xD;
      mouth on the University of Florida campus and in the surrounding area, in May of 2010.&#xD;
      Eligible subjects were randomly assigned to one of two experimental groups, to consume either&#xD;
      50 grams or 100 grams of whole wheat bran cereal daily, for three weeks. Blood was drawn from&#xD;
      fasting subjects before consumption (baseline) and after three weeks of cereal consumption.&#xD;
      Peripheral blood mononuclear cells (PBMC) were isolated and cultured with a broad based&#xD;
      mitogen and autologous serum for 10 days. PBMC were stained with fluorochrome-conjugated&#xD;
      antibodies on Day 0 and Day 10 of culture, at each blood draw. Data was acquired by flow&#xD;
      cytometry and analyzed. Overall compliance was assessed using self-reported data and by&#xD;
      counting left-over bags of cereal.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2010</start_date>
  <completion_date type="Actual">June 2010</completion_date>
  <primary_completion_date type="Actual">June 2010</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>γδ-T cell proliferation</measure>
    <time_frame>Change in Baseline and 3 weeks</time_frame>
    <description>Flow cytometry is used to compare the percentage of γδ-T cells in the total CD3 cell population in the blood of subjects before and after three weeks of consuming whole wheat bran cereal. An increase in that percentage would be suggestive of improved immunity (priming).</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">43</enrollment>
  <condition>Endocrine, Nutritional, Metabolic and Immunity Disorders</condition>
  <arm_group>
    <arm_group_label>50 grams of whole wheat bran cereal</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This arm was randomized to eat 50 grams of whole wheat brand cereal during the day for 3 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>100 grams of whole wheat bran cereal</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This arm was randomized to eat 100 grams of whole wheat brand cereal the day for 3 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>50 grams of whole wheat bran cereal</intervention_name>
    <description>This arm was randomized to eat 50 grams of whole wheat cereal during the day for 3 weeks. At baseline and at week 3 a blood sample was taken to determine if there was any alteration to the proliferation of gamma-delta T-cells.</description>
    <arm_group_label>50 grams of whole wheat bran cereal</arm_group_label>
    <other_name>Kellogg's brand whole wheat bran cereal</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>100 grams of whole wheat bran cereal</intervention_name>
    <description>This arm was randomized to eat 100 grams of whole wheat cereal during the day for 3 weeks. At baseline and at week 3 a blood sample was taken to determine if there was any alteration to the proliferation of gamma-delta T-cells.</description>
    <arm_group_label>100 grams of whole wheat bran cereal</arm_group_label>
    <other_name>Kellogg's brand whole wheat bran cereal</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  generally healthy&#xD;
&#xD;
          -  aged 18-65&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  chronic health problems&#xD;
&#xD;
          -  high blood pressure&#xD;
&#xD;
          -  BMI greater than 25&#xD;
&#xD;
          -  vegan&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 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>Department of Food Science &amp; Human Nutrition, 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>August 2014</verification_date>
  <study_first_submitted>August 5, 2014</study_first_submitted>
  <study_first_submitted_qc>August 5, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 6, 2014</study_first_posted>
  <last_update_submitted>August 5, 2014</last_update_submitted>
  <last_update_submitted_qc>August 5, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 6, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>wheat bran</keyword>
  <keyword>healthy immunity</keyword>
  <keyword>T cells</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Immune System Diseases</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02210234
org study id: 114-2010
nct id: NCT02210234
lead sponsor: 
collaborator: 
has dmc: Yes
The purpose of this research was to understand the effects of bioactive compounds found in
      wheat cereal on human immunity. Subjects came in for a baseline blood draw, consumed whole
      wheat bran cereal daily for 21 days, and returned for a final blood draw. Immune function
      assays were performed at both sampling times. It was predicted that eating wheat bran would
      benefit immune function.
Healthy individuals, between 18 and 50 years of age, were recruited by flyer and word of
      mouth on the University of Florida campus and in the surrounding area, in May of 2010.
      Eligible subjects were randomly assigned to one of two experimental groups, to consume either
      50 grams or 100 grams of whole wheat bran cereal daily, for three weeks. Blood was drawn from
      fasting subjects before consumption (baseline) and after three weeks of cereal consumption.
      Peripheral blood mononuclear cells (PBMC) were isolated and cultured with a broad based
      mitogen and autologous serum for 10 days. PBMC were stained with fluorochrome-conjugated
      antibodies on Day 0 and Day 10 of culture, at each blood draw. Data was acquired by flow
      cytometry and analyzed. Overall compliance was assessed using self-reported data and by
      counting left-over bags of cereal.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: γδ-T cell proliferation
time frame: Change in Baseline and 3 weeks
description: Flow cytometry is used to compare the percentage of γδ-T cells in the total CD3 cell population in the blood of subjects before and after three weeks of consuming whole wheat bran cereal. An increase in that percentage would be suggestive of improved immunity (priming).
arm group label: 50 grams of whole wheat bran cereal
arm group type: Active Comparator
description: This arm was randomized to eat 50 grams of whole wheat brand cereal during the day for 3 weeks.
arm group label: 100 grams of whole wheat bran cereal
arm group type: Active Comparator
description: This arm was randomized to eat 100 grams of whole wheat brand cereal the day for 3 weeks.
intervention type: Dietary Supplement
intervention name: 50 grams of whole wheat bran cereal
description: This arm was randomized to eat 50 grams of whole wheat cereal during the day for 3 weeks. At baseline and at week 3 a blood sample was taken to determine if there was any alteration to the proliferation of gamma-delta T-cells.
arm group label: 50 grams of whole wheat bran cereal
other name: Kellogg's brand whole wheat bran cereal
intervention type: Dietary Supplement
intervention name: 100 grams of whole wheat bran cereal
description: This arm was randomized to eat 100 grams of whole wheat cereal during the day for 3 weeks. At baseline and at week 3 a blood sample was taken to determine if there was any alteration to the proliferation of gamma-delta T-cells.
arm group label: 100 grams of whole wheat bran cereal
other name: Kellogg's brand whole wheat bran cereal
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 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
mesh term: Immune System Diseases