<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/NCT03233503</url>
  </required_header>
  <id_info>
    <org_study_id>NL47315.081.13</org_study_id>
    <nct_id>NCT03233503</nct_id>
  </id_info>
  <brief_title>Taste, Fat Sensation and Texture Study</brief_title>
  <official_title>Taste, Fat Sensation and Texture Study of Dutch and Malaysian Diets</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wageningen University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Taylor's University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Wageningen University</source>
  <brief_summary>
    <textblock>
      Food is selected primarily on their taste and texture properties. It is essential to get more&#xD;
      insight in taste and texture characteristics of the foods in the Dutch and Malaysian diets&#xD;
      for a better understanding of food choices. Currently, there is insufficient information on&#xD;
      taste and texture properties of foods to relate these properties to the composition of diets&#xD;
      and individual food choice in larger (observational) studies.&#xD;
&#xD;
      In the current study, the investigators want to assess the perceived intensities of the 5&#xD;
      basic tastes, i.e. sweet, salt, sour, bitter and umami, as well as fat sensation and texture,&#xD;
      in an array of about 1,000 often consumed Dutch and Malaysian foods. The investigators aim to&#xD;
      do this with a trained sensory panel, which is a well-accepted way of assessing perception of&#xD;
      sensory attributes.&#xD;
&#xD;
      With the current study, the investigators aim to build a table, which is comparable to the&#xD;
      food composition table, but contains data that describes foods and meals in terms of sensory&#xD;
      properties. That is, investigators want to quantify sensory characteristics of about 1,000&#xD;
      commonly eaten Dutch and Malaysian foods. This enables investigators to add sensory&#xD;
      information to the food intake data that is already being collected in observational studies,&#xD;
      and to further understand food choices in specific populations, such as elderly and patient&#xD;
      groups. In current project, the investigators also aim to compare the Dutch diet to the&#xD;
      Malaysian diet in term of sensory properties.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study is an observational study on taste and texture of commonly consumed Dutch and&#xD;
      Malaysian foods with three phases, i.e. screening, training and tasting sessions.&#xD;
&#xD;
      The study will be held in the sensory tasting rooms at Wageningen University, The Netherlands&#xD;
      and Taylor's University, Malaysia, respectively.&#xD;
&#xD;
      After the recruitment and prior to the training and tasting sessions, there will be a 2-hour&#xD;
      screening session (Phase I) during which the investigators will select respective Dutch and&#xD;
      Malaysian participants based on their performance in a sensory test.&#xD;
&#xD;
      During the training session (Phase II), the participants need to commit and involve in 2&#xD;
      1½-hour sessions a week for approximately four- six months (until sufficiently trained).&#xD;
&#xD;
      At the tasting sessions (Phase III), trained Dutch and Malaysian panellist also need to&#xD;
      involve in 2-3 sessions a week for a consecutive three years. Each session will take&#xD;
      approximately 1½ hour. During this session, series of food will be rated for their taste, fat&#xD;
      and texture. In addition, food texture will be measured by eating rate and quantifying the&#xD;
      size of the bites which it is eaten.&#xD;
&#xD;
      The usual performance of the panellist also are discussed with the panellists and monitored&#xD;
      throughout the training phase and regularly (each month) during the tasting phase.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 13, 2014</start_date>
  <completion_date type="Actual">December 22, 2016</completion_date>
  <primary_completion_date type="Actual">December 22, 2016</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Comparison of panel performance results of two trained Dutch and Malaysian panelist</measure>
    <time_frame>Phase II training , an average of 3 hours visit per week</time_frame>
    <description>For individual taste attributes of the reference solutions and reference foods, analysis of variance (ANOVA) was used to evaluate the performance of each panel on discrimination, repeatability and agreement according to the following model:&#xD;
Attribute= µ + product (P) + assessor (A) + replicate (r) + product*assessor (P*A) + product*replicate (P*r) + assessor*replicate (A*r) + E, where product= discrimination, assessor= consistency of ratings between assessors, replicate= consistency of ratings from one session to another, product*replicate= panel repeatability, product*assessor = agreement between assessors, assessor*replicate= assessor repeatability. The replicate scores deviated from the product mean for all taste attributes from the total scale were also reported as root mean squared error (RMSE) of the ANOVA model without replicate effect</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Dutch trained panelist-generated taste intensity ratings of commonly consumed Dutch foods</measure>
    <time_frame>Through study completion, an average of 3hours visit per week</time_frame>
    <description>The intensity rating of taste: sweet, salt, sour, bitter, umami and fat sensation on the 100-point quantitative Spectrum scales</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Malaysian trained panelist-generated taste intensity ratings of commonly consumed Malaysian foods</measure>
    <time_frame>Through study completion, an average of 3hours visit per week</time_frame>
    <description>The intensity rating of taste: sweet, salt, sour, bitter, umami and fat sensation on the 100-point quantitative Spectrum scales</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The behavior measures of food texture related properties of commonly consumed foods</measure>
    <time_frame>Through study completion, an average of 3hours visit per week</time_frame>
    <description>The eating rate was measured and the bite size was quantified</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">35</enrollment>
  <condition>Taste Perception</condition>
  <condition>Fat Sensation</condition>
  <condition>Eating Rate</condition>
  <condition>Bite Size</condition>
  <arm_group>
    <arm_group_label>Dutch trained taste panel</arm_group_label>
    <description>The study population consists of a sample of 15 healthy Dutch males and females, recruited in the Wageningen area.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Malaysian trained taste panel</arm_group_label>
    <description>The study population consists of a sample of 20 healthy Malaysian males and females, recruited in the Subang Jaya, Selangor area.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Basic taste, fat sensation and texture perception</intervention_name>
    <description>This is an observational Sensory study methodologically similar to &quot;Astringency and bitterness perception clinicalTrials.gov identifier NCT03171402 &quot;Participants are first involved in sensory training sessions that train how they recognise between different basic tastes and differentiate perceived intensity in solutions and foods. After 6 months of training, the trained participants are involved in tasting a wide array of commonly consumed foods. At this study phase, participants will rate for the foods' taste, fat sensation perception and texture</description>
    <arm_group_label>Dutch trained taste panel</arm_group_label>
    <arm_group_label>Malaysian trained taste panel</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Only Dutchs are allowed to participate as Dutch taste panel; and only Malaysians are&#xD;
        allowed to participate as Malaysian taste panel&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age: 18-55 years&#xD;
&#xD;
          -  BMI: 18.5-25kg/m2 (self-reported)&#xD;
&#xD;
          -  Physically and mentally healthy as not suffering or under control by any medications&#xD;
&#xD;
          -  Available during the whole period and shown to be committed to participate 3 times/wk&#xD;
&#xD;
          -  Good performance on the sensory tests during the screening&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Smoking (equal or more than 1 unit per day and those stopped smoking less than3&#xD;
             months)&#xD;
&#xD;
          -  Excessive alcoholic consumer (more than 21 units per week)&#xD;
&#xD;
          -  Being vegetarian or having religious dietary restrictions&#xD;
&#xD;
          -  Reported to have certain dental limitations (denture, tongue piercing or difficulties&#xD;
             in chewing and swallowing)&#xD;
&#xD;
          -  Reported intolerance or allergies to foods&#xD;
&#xD;
          -  Using medications that are known to affect taste and smell identification&#xD;
&#xD;
          -  Being pregnant or lactating&#xD;
&#xD;
          -  Participating and/or planning to participate in other studies for the coming three&#xD;
             years&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Monica Mars, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Wageningen University</affiliation>
  </overall_official>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>July 20, 2017</study_first_submitted>
  <study_first_submitted_qc>July 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2017</study_first_posted>
  <last_update_submitted>July 28, 2017</last_update_submitted>
  <last_update_submitted_qc>July 28, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 1, 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/NCT03233503
org study id: NL47315.081.13
nct id: NCT03233503
lead sponsor: 
collaborator: 
Food is selected primarily on their taste and texture properties. It is essential to get more
      insight in taste and texture characteristics of the foods in the Dutch and Malaysian diets
      for a better understanding of food choices. Currently, there is insufficient information on
      taste and texture properties of foods to relate these properties to the composition of diets
      and individual food choice in larger (observational) studies.

      In the current study, the investigators want to assess the perceived intensities of the 5
      basic tastes, i.e. sweet, salt, sour, bitter and umami, as well as fat sensation and texture,
      in an array of about 1,000 often consumed Dutch and Malaysian foods. The investigators aim to
      do this with a trained sensory panel, which is a well-accepted way of assessing perception of
      sensory attributes.

      With the current study, the investigators aim to build a table, which is comparable to the
      food composition table, but contains data that describes foods and meals in terms of sensory
      properties. That is, investigators want to quantify sensory characteristics of about 1,000
      commonly eaten Dutch and Malaysian foods. This enables investigators to add sensory
      information to the food intake data that is already being collected in observational studies,
      and to further understand food choices in specific populations, such as elderly and patient
      groups. In current project, the investigators also aim to compare the Dutch diet to the
      Malaysian diet in term of sensory properties.
The study is an observational study on taste and texture of commonly consumed Dutch and
      Malaysian foods with three phases, i.e. screening, training and tasting sessions.

      The study will be held in the sensory tasting rooms at Wageningen University, The Netherlands
      and Taylor's University, Malaysia, respectively.

      After the recruitment and prior to the training and tasting sessions, there will be a 2-hour
      screening session (Phase I) during which the investigators will select respective Dutch and
      Malaysian participants based on their performance in a sensory test.

      During the training session (Phase II), the participants need to commit and involve in 2
      1½-hour sessions a week for approximately four- six months (until sufficiently trained).

      At the tasting sessions (Phase III), trained Dutch and Malaysian panellist also need to
      involve in 2-3 sessions a week for a consecutive three years. Each session will take
      approximately 1½ hour. During this session, series of food will be rated for their taste, fat
      and texture. In addition, food texture will be measured by eating rate and quantifying the
      size of the bites which it is eaten.

      The usual performance of the panellist also are discussed with the panellists and monitored
      throughout the training phase and regularly (each month) during the tasting phase.
observational model: Other
time perspective: Cross-Sectional
measure: Comparison of panel performance results of two trained Dutch and Malaysian panelist
time frame: Phase II training , an average of 3 hours visit per week
description: For individual taste attributes of the reference solutions and reference foods, analysis of variance (ANOVA) was used to evaluate the performance of each panel on discrimination, repeatability and agreement according to the following model:
Attribute= µ + product (P) + assessor (A) + replicate (r) + product*assessor (P*A) + product*replicate (P*r) + assessor*replicate (A*r) + E, where product= discrimination, assessor= consistency of ratings between assessors, replicate= consistency of ratings from one session to another, product*replicate= panel repeatability, product*assessor = agreement between assessors, assessor*replicate= assessor repeatability. The replicate scores deviated from the product mean for all taste attributes from the total scale were also reported as root mean squared error (RMSE) of the ANOVA model without replicate effect
measure: Dutch trained panelist-generated taste intensity ratings of commonly consumed Dutch foods
time frame: Through study completion, an average of 3hours visit per week
description: The intensity rating of taste: sweet, salt, sour, bitter, umami and fat sensation on the 100-point quantitative Spectrum scales
measure: Malaysian trained panelist-generated taste intensity ratings of commonly consumed Malaysian foods
time frame: Through study completion, an average of 3hours visit per week
description: The intensity rating of taste: sweet, salt, sour, bitter, umami and fat sensation on the 100-point quantitative Spectrum scales
measure: The behavior measures of food texture related properties of commonly consumed foods
time frame: Through study completion, an average of 3hours visit per week
description: The eating rate was measured and the bite size was quantified
arm group label: Dutch trained taste panel
description: The study population consists of a sample of 15 healthy Dutch males and females, recruited in the Wageningen area.
arm group label: Malaysian trained taste panel
description: The study population consists of a sample of 20 healthy Malaysian males and females, recruited in the Subang Jaya, Selangor area.
intervention type: Diagnostic Test
intervention name: Basic taste, fat sensation and texture perception
description: This is an observational Sensory study methodologically similar to "Astringency and bitterness perception clinicalTrials.gov identifier NCT03171402 "Participants are first involved in sensory training sessions that train how they recognise between different basic tastes and differentiate perceived intensity in solutions and foods. After 6 months of training, the trained participants are involved in tasting a wide array of commonly consumed foods. At this study phase, participants will rate for the foods' taste, fat sensation perception and texture
arm group label: Dutch trained taste panel
arm group label: Malaysian trained taste panel
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Monica Mars, PhD
role: Study Chair
affiliation: Wageningen University
responsible party type: Sponsor