<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/NCT03227887</url>
  </required_header>
  <id_info>
    <org_study_id>VVW Alimassens cereales</org_study_id>
    <nct_id>NCT03227887</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 Cereal Products in Elderly People</brief_title>
  <official_title>Evaluation of the Link Between the Characteristics of Oral Physiology and Formation of the Food Bolus During the Consumption of Cereal Products in Elderly People Via a Modelling Approach.</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 foods such as Sponge cake or Brioche are broken&#xD;
      down in the mouth. More specifically, investigators wish to evaluate the link between oral&#xD;
      physiology (salivation and mastication) and (i) formation of the food bolus during the&#xD;
      consumption of Sponge cake or Brioche, that is to say the way in which the food is broken&#xD;
      down to be swallowed (ii) mouthfeel during the consumption of Sponge cake or Brioche, meaning&#xD;
      the sensations that participant feel when they eat these products.&#xD;
&#xD;
      The study will take place at the INRA in Dijon during 7 one-hour sessions spread over 3&#xD;
      months. The first session will allow us to characterise the chewing behaviour of the subjects&#xD;
      and their salivation, and will enable us to train them in the instructions for the following&#xD;
      sessions. The 6 other sessions will allow us to study the structure of the food bolus while&#xD;
      being formed and the mouthfeel of the foods in the project.&#xD;
&#xD;
      In the first session:&#xD;
&#xD;
        -  Two samples of saliva will be taken&#xD;
&#xD;
        -  A video will be made of subjects eating Sponge cake or Brioche&#xD;
&#xD;
        -  Subjects will be trained in exercises for the following sessions - this will consist in&#xD;
           chewing the study foods and spitting them out on the experimenter's signal.&#xD;
&#xD;
      During the 6 other sessions, subjects will be asked to:&#xD;
&#xD;
        -  Chew one of the study foods and spit it out on the signal of the experimenter.&#xD;
&#xD;
        -  Evaluate the mouthfeel while eating Sponge cake or Brioche by answering different&#xD;
           questions. This test will be done during 4 of the 6 sessions.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 6, 2016</start_date>
  <completion_date type="Actual">September 2016</completion_date>
  <primary_completion_date type="Actual">September 2016</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 during consumption of cereal products</measure>
    <time_frame>At baseline</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Frequency of chewing during consumption of cereal products</measure>
    <time_frame>At baseline</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Rheology test</measure>
    <time_frame>Up to 3 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Calculation of insalivation rates</measure>
    <time_frame>Up to 3 months</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</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 1st will be used to measure the flow of naturally secreted saliva&#xD;
With stimulation: The 2nd 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 the subjects to chew the food and the number of bites they use before swallowing The test will be done twice.</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>2 tests:&#xD;
Evaluate using a compression test the structure of each bolus to determine their degree of destructuration over time Measure the quantity of the saliva incorporated&#xD;
The bolus will be analysed visually</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>Mouthfeel</intervention_name>
    <description>Describe the mouthfeel by answering a paper questionnaire after consumption of the cereal products</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 (cereal 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>
  <location>
    <facility>
      <name>CHU Dijon Bourgogne</name>
      <address>
        <city>Dijon</city>
        <zip>21079</zip>
        <country>France</country>
      </address>
    </facility>
  </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/NCT03227887
org study id: VVW Alimassens cereales
nct id: NCT03227887
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to understand how foods such as Sponge cake or Brioche are broken
      down in the mouth. More specifically, investigators wish to evaluate the link between oral
      physiology (salivation and mastication) and (i) formation of the food bolus during the
      consumption of Sponge cake or Brioche, that is to say the way in which the food is broken
      down to be swallowed (ii) mouthfeel during the consumption of Sponge cake or Brioche, meaning
      the sensations that participant feel when they eat these products.

      The study will take place at the INRA in Dijon during 7 one-hour sessions spread over 3
      months. The first session will allow us to characterise the chewing behaviour of the subjects
      and their salivation, and will enable us to train them in the instructions for the following
      sessions. The 6 other sessions will allow us to study the structure of the food bolus while
      being formed and the mouthfeel of the foods in the project.

      In the first session:

        -  Two samples of saliva will be taken

        -  A video will be made of subjects eating Sponge cake or Brioche

        -  Subjects will be trained in exercises for the following sessions - this will consist in
           chewing the study foods and spitting them out on the experimenter's signal.

      During the 6 other sessions, subjects will be asked to:

        -  Chew one of the study foods and spit it out on the signal of the experimenter.

        -  Evaluate the mouthfeel while eating Sponge cake or Brioche by answering different
           questions. This test will be done during 4 of the 6 sessions.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Duration of chewing during consumption of cereal products
time frame: At baseline
measure: Frequency of chewing during consumption of cereal products
time frame: At baseline
measure: Rheology test
time frame: Up to 3 months
measure: Calculation of insalivation rates
time frame: Up to 3 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 1st will be used to measure the flow of naturally secreted saliva
With stimulation: The 2nd 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 the subjects to chew the food and the number of bites they use before swallowing The test will be done twice.
arm group label: Good chewing ability
arm group label: Impaired chewing ability
intervention type: Other
intervention name: Study of the food bolus
description: 2 tests:
Evaluate using a compression test the structure of each bolus to determine their degree of destructuration over time Measure the quantity of the saliva incorporated
The bolus will be analysed visually
arm group label: Good chewing ability
arm group label: Impaired chewing ability
intervention type: Other
intervention name: Mouthfeel
description: Describe the mouthfeel by answering a paper questionnaire after consumption of the cereal products
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
facility: 
country: France
responsible party type: Sponsor