<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/NCT02262091</url>
  </required_header>
  <id_info>
    <org_study_id>12.22.NRC</org_study_id>
    <nct_id>NCT02262091</nct_id>
  </id_info>
  <brief_title>Immune Benefits of WGP in Elderly</brief_title>
  <official_title>Strengthening Immunity of Prefrail and Frail Elderly by WGP</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Société des Produits Nestlé (SPN)</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Société des Produits Nestlé (SPN)</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this research is to assess the immune enhancing property of food fibers in the&#xD;
      elderly population.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">December 2014</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 from baseline at 4 weeks post-vaccination in antibody titers levels</measure>
    <time_frame>Up to 1 month</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Measure of seroconversion</measure>
    <time_frame>Up to 2 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measure of cytokines production</measure>
    <time_frame>Up to 2 months 2014</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measure the occurence of clinical endpoints</measure>
    <time_frame>Up to 2 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measure of seroprotection</measure>
    <time_frame>Up to 2 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Elderly People</condition>
  <arm_group>
    <arm_group_label>Placebo group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Food fibers</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Food fibers</intervention_name>
    <arm_group_label>Food fibers</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Maltodextrin</intervention_name>
    <arm_group_label>Placebo group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Influenza vaccine (incl. criterion)</intervention_name>
    <arm_group_label>Food fibers</arm_group_label>
    <arm_group_label>Placebo group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male and female elderly volunteers equal or above age of 70&#xD;
&#xD;
          -  Pre-frail and frail subjects (based on Fried's criteria)&#xD;
&#xD;
          -  Willing to be vaccinated against influenza and having no contraindication to receive&#xD;
             influenza vaccination&#xD;
&#xD;
          -  Having obtained his/her (or his/her legal representative's) informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject with a rapidly deteriorating health status (terminal, severe, or uncontrolled&#xD;
             acute/chronic diseases)&#xD;
&#xD;
          -  Allergy to eggs or influenza vaccine components.&#xD;
&#xD;
          -  Subject who has received any vaccination in the last 3 months or has previously been&#xD;
             vaccinated with the current seasonal influenza vaccine.&#xD;
&#xD;
          -  Subject who is currently taking, or has taken in the last 4 weeks, or will take immune&#xD;
             modulating medication during the study, including steroid, immune suppressive&#xD;
             treatment.&#xD;
&#xD;
          -  Subject who has taken antibiotics in the last 2 months prior to entering the study.&#xD;
&#xD;
          -  Subject who is consuming regularly prebiotic and/or probiotic supplements, yogurts,&#xD;
             and/or other dietary supplements.&#xD;
&#xD;
          -  Personal or family history of Guillain-Barre syndrome&#xD;
&#xD;
          -  BMI&gt;35 kg/m2&#xD;
&#xD;
          -  Subject who has received blood transfusion or had a blood donation during the last 4&#xD;
             weeks prior to the beginning of this study.&#xD;
&#xD;
          -  Subject who cannot be expected to comply with the study procedures&#xD;
&#xD;
          -  Currently participating or having participated in another clinical trial during the&#xD;
             last 4 weeks prior to the beginning of this study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>70 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>Leiter des Geriatrischen Zentrums Oldenburg (GZO)</name>
      <address>
        <city>Oldenburg</city>
        <zip>26133</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>October 8, 2013</study_first_submitted>
  <study_first_submitted_qc>October 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 10, 2014</study_first_posted>
  <last_update_submitted>April 9, 2015</last_update_submitted>
  <last_update_submitted_qc>April 9, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 10, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT02262091
org study id: 12.22.NRC
nct id: NCT02262091
lead sponsor: 
has dmc: No
The aim of this research is to assess the immune enhancing property of food fibers in the
      elderly population.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change from baseline at 4 weeks post-vaccination in antibody titers levels
time frame: Up to 1 month
measure: Measure of seroconversion
time frame: Up to 2 months
measure: Measure of cytokines production
time frame: Up to 2 months 2014
measure: Measure the occurence of clinical endpoints
time frame: Up to 2 months
measure: Measure of seroprotection
time frame: Up to 2 months
arm group label: Placebo group
arm group type: Placebo Comparator
arm group label: Food fibers
arm group type: Experimental
intervention type: Dietary Supplement
intervention name: Food fibers
arm group label: Food fibers
intervention type: Dietary Supplement
intervention name: Maltodextrin
arm group label: Placebo group
intervention type: Biological
intervention name: Influenza vaccine (incl. criterion)
arm group label: Food fibers
arm group label: Placebo group
criteria: 
gender: All
minimum age: 70 Years
maximum age: N/A
facility: 
country: Germany
responsible party type: Sponsor