<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/NCT02244476</url>
  </required_header>
  <id_info>
    <org_study_id>NIZO 105356</org_study_id>
    <nct_id>NCT02244476</nct_id>
  </id_info>
  <brief_title>Acoustic Tribology Validation Study</brief_title>
  <official_title>Validation Study to Evaluate the Use of Acoustic Tribology to Assess Mouthfeel of Dairy Drinks</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NIZO Food Research</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Top Institute Food and Nutrition</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>NIZO Food Research</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Dairy-based beverages contain fat and sugars. As both contribute to the energy intake upon&#xD;
      consumption, food industry strives to reduce these ingredients while maintaining the taste,&#xD;
      texture and aroma properties of the beverages. A successful reduction of fat and sugar from&#xD;
      drinks has still proven a great challenge since consumers have less preference for the mouth&#xD;
      feel of reformulated beverages than for the regular beverages. Mainly because instrumental&#xD;
      measures like rheology and traditional tribology do not entirely predict the experienced&#xD;
      mouth feel, there is an interest in alternative correlates for mouth feel aspects related to&#xD;
      fat and sugar perception. In a recent study it was demonstrated that vibrations produced&#xD;
      during interaction between the tongue, palate and beverages during consumption are very&#xD;
      sensitive to the amount of fat and texturizers in the beverage. The present study aims at&#xD;
      clarifying that relation for a larger panel of human subjects, by systematically evaluating&#xD;
      vibration spectra during consumption of dairy beverages that differ in fat content, sugar&#xD;
      content or pH. Secondly, the correlation of vibration spectra (acoustic tribology) with mouth&#xD;
      feel-related sensory properties and composition of fat deposits on the tongue will be&#xD;
      assessed.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2014</start_date>
  <completion_date type="Actual">January 2015</completion_date>
  <primary_completion_date type="Actual">January 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Powers in segments of time-frequency transferred vibration data</measure>
    <time_frame>between 2s and 20s after consumption of each sip</time_frame>
    <description>Spectral powers of acoustic signals (in V^2/s) produced by tongue-palate interactions during consumption of various foods in the bands 60-300Hz and 400-2000Hz.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Ratios of powers in segments of time-frequency transferred vibration data</measure>
    <time_frame>2-20 seconds after consumption of each sip</time_frame>
    <description>Ratios of spectral powers in the 400-2000Hz band over powers in the 60-300Hz band of acoustic signals produced by tongue-palate interactions during consumption of various foods (unit-free).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Reported rating of product thickness</measure>
    <time_frame>0-2 sec after consumption of each sip</time_frame>
    <description>Evaluation of product thickness on a Visual Analogue Scale (mm distance from the lower anchor)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relative fat content in the collected tongue coating</measure>
    <time_frame>2-20 sec after consumption of each sip</time_frame>
    <description>percentage of fat encountered in tongue coating that was collected with a swab immediately after consumption</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reported rating of product Creaminess</measure>
    <time_frame>0-2 sec after consumption of each sip</time_frame>
    <description>Evaluation of product creaminess on a Visual Analogue Scale (mm distance from the lower anchor)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reported rating of product Roughness</measure>
    <time_frame>0-2 sec after consumption of each sip</time_frame>
    <description>Evaluation of product roughness on a Visual Analogue Scale (mm distance from the lower anchor)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relative sugar content in the collected tongue coating</measure>
    <time_frame>2-20 seconds after bite consumption</time_frame>
    <description>percentage of sugars encountered in tongue coating that was collected with a swab immediately after consumption</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relative protein content in the collected tongue coating</measure>
    <time_frame>2-20 seconds after bite consumption</time_frame>
    <description>percentage of protein encountered in tongue coating that was collected with a swab immediately after consumption</description>
  </secondary_outcome>
  <enrollment type="Actual">17</enrollment>
  <condition>Mouth Feel in Relation to Food Preference and Energy Intake</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      tongue scrapings&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        16 volunteers from the local general population&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18-65 years&#xD;
&#xD;
          -  Healthy set of teeth&#xD;
&#xD;
          -  Ability to work with sensory descriptors for dairy products.&#xD;
&#xD;
          -  Able to produce an acoustic signal that is larger than the background signal&#xD;
&#xD;
          -  Voluntary participation&#xD;
&#xD;
          -  Having given written informed consent&#xD;
&#xD;
          -  Willing to comply with study procedures&#xD;
&#xD;
          -  Willing to accept use of all encoded data, including publication, and the confidential&#xD;
             use and storage of all data&#xD;
&#xD;
          -  Willing to accept disclosure of the financial benefit of participation in the study to&#xD;
             the authorities concerned&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Wearing dentures&#xD;
&#xD;
          -  Inability to comply with instructions for acoustic tribology&#xD;
&#xD;
          -  A self-reported food allergy or sensitivity for ingredients of the test products&#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>Harold Bult, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>NIZO Food Research</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>NIZO food research</name>
      <address>
        <city>Ede</city>
        <zip>6718 ZB</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>September 8, 2014</study_first_submitted>
  <study_first_submitted_qc>September 16, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 19, 2014</study_first_posted>
  <last_update_submitted>October 13, 2017</last_update_submitted>
  <last_update_submitted_qc>October 13, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 16, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>mouth feel</keyword>
  <keyword>acoustic tribology</keyword>
  <keyword>vibration spectrum</keyword>
  <keyword>sensory perception</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/NCT02244476
org study id: NIZO 105356
nct id: NCT02244476
lead sponsor: 
collaborator: 
has dmc: No
Dairy-based beverages contain fat and sugars. As both contribute to the energy intake upon
      consumption, food industry strives to reduce these ingredients while maintaining the taste,
      texture and aroma properties of the beverages. A successful reduction of fat and sugar from
      drinks has still proven a great challenge since consumers have less preference for the mouth
      feel of reformulated beverages than for the regular beverages. Mainly because instrumental
      measures like rheology and traditional tribology do not entirely predict the experienced
      mouth feel, there is an interest in alternative correlates for mouth feel aspects related to
      fat and sugar perception. In a recent study it was demonstrated that vibrations produced
      during interaction between the tongue, palate and beverages during consumption are very
      sensitive to the amount of fat and texturizers in the beverage. The present study aims at
      clarifying that relation for a larger panel of human subjects, by systematically evaluating
      vibration spectra during consumption of dairy beverages that differ in fat content, sugar
      content or pH. Secondly, the correlation of vibration spectra (acoustic tribology) with mouth
      feel-related sensory properties and composition of fat deposits on the tongue will be
      assessed.
observational model: Other
time perspective: Other
measure: Powers in segments of time-frequency transferred vibration data
time frame: between 2s and 20s after consumption of each sip
description: Spectral powers of acoustic signals (in V^2/s) produced by tongue-palate interactions during consumption of various foods in the bands 60-300Hz and 400-2000Hz.
measure: Ratios of powers in segments of time-frequency transferred vibration data
time frame: 2-20 seconds after consumption of each sip
description: Ratios of spectral powers in the 400-2000Hz band over powers in the 60-300Hz band of acoustic signals produced by tongue-palate interactions during consumption of various foods (unit-free).
measure: Reported rating of product thickness
time frame: 0-2 sec after consumption of each sip
description: Evaluation of product thickness on a Visual Analogue Scale (mm distance from the lower anchor)
measure: Relative fat content in the collected tongue coating
time frame: 2-20 sec after consumption of each sip
description: percentage of fat encountered in tongue coating that was collected with a swab immediately after consumption
measure: Reported rating of product Creaminess
time frame: 0-2 sec after consumption of each sip
description: Evaluation of product creaminess on a Visual Analogue Scale (mm distance from the lower anchor)
measure: Reported rating of product Roughness
time frame: 0-2 sec after consumption of each sip
description: Evaluation of product roughness on a Visual Analogue Scale (mm distance from the lower anchor)
measure: Relative sugar content in the collected tongue coating
time frame: 2-20 seconds after bite consumption
description: percentage of sugars encountered in tongue coating that was collected with a swab immediately after consumption
measure: Relative protein content in the collected tongue coating
time frame: 2-20 seconds after bite consumption
description: percentage of protein encountered in tongue coating that was collected with a swab immediately after consumption
tongue scrapings
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Harold Bult, PhD
role: Principal Investigator
affiliation: NIZO Food Research
facility: 
country: Netherlands
responsible party type: Sponsor