<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/NCT03227913</url>
  </required_header>
  <id_info>
    <org_study_id>VVW Alimassens lait ANR 2014</org_study_id>
    <nct_id>NCT03227913</nct_id>
  </id_info>
  <brief_title>Evaluate the Link Between the Characteristics of Oral Physiology and the Formation of the Food Bolus During the Consumption of Dairy Products in Elderly People</brief_title>
  <acronym>AlimaSSenSLait</acronym>
  <official_title>Evaluate the Link Between the Characteristics of Oral Physiology and the Formation of the Food Bolus During the Consumption of Cheese Products in Elderly People</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire Dijon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire Dijon</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to understand how dairy products enriched in minerals and proteins&#xD;
      are broken down in the mouth. More specifically, investigators wish to evaluate the link&#xD;
      between oral physiology (salivation and mastication) and formation of the food bolus during&#xD;
      the consumption of enriched cheese, that is to say the way in which the food is broken down&#xD;
      to be swallowed.&#xD;
&#xD;
      The study will take place at the INRA in Dijon during 2 one-hour sessions spread over 4&#xD;
      months. These two sessions will allow investigators to characterise the chewing behaviour of&#xD;
      the subjects and their salivation, and the structure of the food bolus formed when eating the&#xD;
      four products of the project.&#xD;
&#xD;
      For each of the four foods in each session:&#xD;
&#xD;
        -  Two samples of saliva will be taken&#xD;
&#xD;
        -  A video will be made of subjects eating one of the study products&#xD;
&#xD;
        -  Subjects will chew the study foods and spit them out.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 28, 2016</start_date>
  <completion_date type="Anticipated">September 2017</completion_date>
  <primary_completion_date type="Anticipated">July 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Duration of chewing</measure>
    <time_frame>Change from baseline at 4 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Frequency of chewing</measure>
    <time_frame>Change from baseline at 4 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Rheology test</measure>
    <time_frame>Change from baseline at 4 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>calculation of insanity rate</measure>
    <time_frame>Change from baseline at 4 months</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Old Person</condition>
  <arm_group>
    <arm_group_label>Good chewing ability</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Impaired chewing ability</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Two samples of saliva</intervention_name>
    <description>Without stimulation: the first will be used to measure the flow of naturally secreted saliva&#xD;
With stimulation: the second will will be used to measure the flow and viscosity of the saliva secreted after stimulation</description>
    <arm_group_label>Good chewing ability</arm_group_label>
    <arm_group_label>Impaired chewing ability</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Chewing behaviour</intervention_name>
    <description>Measure the time taken by subjects to chew the food and the number of bites they use before swallowing</description>
    <arm_group_label>Good chewing ability</arm_group_label>
    <arm_group_label>Impaired chewing ability</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Study of the food bolus</intervention_name>
    <description>Analysis by a compression and viscosity test&#xD;
Evaluation of the quantity of saliva incorporated by drying</description>
    <arm_group_label>Good chewing ability</arm_group_label>
    <arm_group_label>Impaired chewing ability</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Persons who have provided written consent&#xD;
&#xD;
          -  Age ≥ 65 years old&#xD;
&#xD;
          -  Persons living at home&#xD;
&#xD;
          -  Persons who can travel independently&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Adults under guardianship&#xD;
&#xD;
          -  Persons without health insurance cover&#xD;
&#xD;
          -  Persons in hospital&#xD;
&#xD;
          -  Persons in institutions&#xD;
&#xD;
          -  Persons whose Mini-Mental State Examination (MMSE) is &lt; 24&#xD;
&#xD;
          -  Persons requiring enteral or parenteral nutrition&#xD;
&#xD;
          -  Persons who in the previous 12 months received € 4500 for taking part in clinical&#xD;
             trials, including the present study&#xD;
&#xD;
          -  Persons in a period of exclusion of a previous study&#xD;
&#xD;
          -  Food allergies (dairy products in particular)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Patrick MANCKOUNDIA</last_name>
    <phone>3 80 29 39 70</phone>
    <phone_ext>+33</phone_ext>
    <email>patrick.manckoundia@chu-dijon.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>CHU Dijon Bourgogne</name>
      <address>
        <city>Dijon</city>
        <zip>21079</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Patrick MANCKOUNDIA</last_name>
      <phone>3 80 29 39 70</phone>
      <phone_ext>+33</phone_ext>
      <email>patrick.manckoundia@chu-dijon.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>June 26, 2017</study_first_submitted>
  <study_first_submitted_qc>July 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2017</study_first_posted>
  <last_update_submitted>July 21, 2017</last_update_submitted>
  <last_update_submitted_qc>July 21, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 24, 2017</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/NCT03227913
org study id: VVW Alimassens lait ANR 2014
nct id: NCT03227913
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to understand how dairy products enriched in minerals and proteins
      are broken down in the mouth. More specifically, investigators wish to evaluate the link
      between oral physiology (salivation and mastication) and formation of the food bolus during
      the consumption of enriched cheese, that is to say the way in which the food is broken down
      to be swallowed.

      The study will take place at the INRA in Dijon during 2 one-hour sessions spread over 4
      months. These two sessions will allow investigators to characterise the chewing behaviour of
      the subjects and their salivation, and the structure of the food bolus formed when eating the
      four products of the project.

      For each of the four foods in each session:

        -  Two samples of saliva will be taken

        -  A video will be made of subjects eating one of the study products

        -  Subjects will chew the study foods and spit them out.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Duration of chewing
time frame: Change from baseline at 4 months
measure: Frequency of chewing
time frame: Change from baseline at 4 months
measure: Rheology test
time frame: Change from baseline at 4 months
measure: calculation of insanity rate
time frame: Change from baseline at 4 months
arm group label: Good chewing ability
arm group type: Active Comparator
arm group label: Impaired chewing ability
arm group type: Experimental
intervention type: Other
intervention name: Two samples of saliva
description: Without stimulation: the first will be used to measure the flow of naturally secreted saliva
With stimulation: the second will will be used to measure the flow and viscosity of the saliva secreted after stimulation
arm group label: Good chewing ability
arm group label: Impaired chewing ability
intervention type: Other
intervention name: Chewing behaviour
description: Measure the time taken by subjects to chew the food and the number of bites they use before swallowing
arm group label: Good chewing ability
arm group label: Impaired chewing ability
intervention type: Other
intervention name: Study of the food bolus
description: Analysis by a compression and viscosity test
Evaluation of the quantity of saliva incorporated by drying
arm group label: Good chewing ability
arm group label: Impaired chewing ability
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Patrick MANCKOUNDIA
phone: 3 80 29 39 70
phone ext: +33
email: patrick.manckoundia@chu-dijon.fr
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor