xml: <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/NCT05985928</url>
    </required_header>
    <id_info>
      <org_study_id>2587</org_study_id>
      <secondary_id>R21DC018906</secondary_id>
      <nct_id>NCT05985928</nct_id>
    </id_info>
    <brief_title>Sensory Study: Taste and Tongue Biology</brief_title>
    <acronym>SweetTaste</acronym>
    <official_title>Sensory Study: Taste and Tongue Biology</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Massachusetts, Amherst</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Institute on Deafness and Other Communication Disorders (NIDCD)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
    </sponsors>
    <source>University of Massachusetts, Amherst</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Researchers will investigate the correlation between a) self-reported dietary intake of foods&#xD;
        and beverages, b) intensity of sucrose stimuli, and c) liking rating of sweet stimuli, with&#xD;
        the relative expression of the taste receptor genes from human fungiform papillae (TAS1R2 and&#xD;
        TAS1R3).&#xD;
  &#xD;
        * This research will provide new information on how sweet taste perception is regulated.&#xD;
  &#xD;
          -  The hypothesis: Greater dietary consumption of sugar and sweet foods is associated with&#xD;
             reduced expression of the sweet taste receptors.&#xD;
  &#xD;
          -  The results of this study could help to identify pathways to help modify sweet taste&#xD;
             perception by uncovering this mechanism.&#xD;
  &#xD;
        Participants will sample solutions prepared with sweet ingredients, provide salivary DNA, and&#xD;
        collect fungiform papillae. This will allow researchers and investigators to compare the&#xD;
        relationship between the sweetness of stimuli, genetic differences in sweet taste receptors,&#xD;
        and expression levels of sweet taste receptor genes.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">March 20, 2023</start_date>
    <completion_date type="Actual">May 20, 2023</completion_date>
    <primary_completion_date type="Actual">May 20, 2023</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>Gene expression and sweet taste perception</measure>
      <time_frame>Day 1 (single time-point)</time_frame>
      <description>The relative level of gene expression of sweet taste receptors (TAS1R2 and TAS1R3) and relationship with sweet taste perception (gLMS ratings of sampled sucrose)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Gene expression and sweet taste liking</measure>
      <time_frame>Day 1 (single time-point)</time_frame>
      <description>The relative level of gene expression of sweet taste receptors (TAS1R2 and TAS1R3) and relationship with sweet taste perception (hedonic ratings of sampled sucrose)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Gene expression and dietary intake</measure>
      <time_frame>Day 1 (single time-point)</time_frame>
      <description>The relative gene level expression of sweet taste receptors and relationship with self-reported dietary intake of sweet foods and beverages</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Gene expression and sweet liker status</measure>
      <time_frame>Day 1 (single time-point)</time_frame>
      <description>The relative gene level expression of sweet taste receptors and relationship with the self-reported liking of a variety of sweet foods and beverages</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Genetics and sweet taste perception</measure>
      <time_frame>Day 1 (single time-point)</time_frame>
      <description>Genetic variability in sweet taste receptor genes and the relationship with perception of sweet stimuli (gLMS intensity ratings)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Genetics and sweet taste liking</measure>
      <time_frame>Day 1 (single time-point)</time_frame>
      <description>Genetic variability in sweet taste receptor genes and the relationship with hedonic ratings of sweet stimuli (hedonic ratings)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Genetics and sweet liker status</measure>
      <time_frame>Day 1 (single time-point)</time_frame>
      <description>Genetic variability in sweet taste receptor genes and the relationship with the self-reported liking of sweet-tasting foods and beverages</description>
    </secondary_outcome>
    <enrollment type="Actual">121</enrollment>
    <condition>Healthy Adults</condition>
    <biospec_retention>Samples With DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        saliva, tissue&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          Healthy adults, over the age of 18, able to provide consent in English, able to complete&#xD;
          survey on an electronic device&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. between 18 and 45 years old,&#xD;
  &#xD;
            2. have no tongue or cheek piercings,&#xD;
  &#xD;
            3. not a user of tobacco products or electronic cigarettes (within the last year),&#xD;
  &#xD;
            4. no known defects in taste or smell,&#xD;
  &#xD;
            5. not pregnant or breastfeeding,&#xD;
  &#xD;
            6. no history of chronic pain in the mouth,&#xD;
  &#xD;
            7. not taking any prescription pain medication,&#xD;
  &#xD;
            8. not taking any blood thinners,&#xD;
  &#xD;
            9. no history of cancer or cancer treatment,&#xD;
  &#xD;
           10. not diabetic or restricting intake of sugars for medical reasons, under the direction&#xD;
               of a physician or healthcare provider&#xD;
  &#xD;
           11. willing to undergo the Fungiform Papillae biopsy procedure&#xD;
  &#xD;
           12. willing to provide salivary DNA&#xD;
  &#xD;
           13. Not currently experiencing any COVID-19 symptoms&#xD;
  &#xD;
           14. Not recently diagnosed (in the last 30 days) with COVID-19&#xD;
  &#xD;
           15. No history of high blood pressure&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          -&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>45 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>University of Massachusetts</name>
        <address>
          <city>Amherst</city>
          <state>Massachusetts</state>
          <zip>01003</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>May 2023</verification_date>
    <study_first_submitted>July 13, 2023</study_first_submitted>
    <study_first_submitted_qc>August 2, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 2, 2023</last_update_submitted>
    <last_update_submitted_qc>August 2, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>sweet</keyword>
    <keyword>genetics</keyword>
    <keyword>gene expression</keyword>
    <keyword>dietary intake</keyword>
    <keyword>psychophysics</keyword>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Data will be shared at the request, after signing release form. No PHI will be included. All data will be de-identified. Data and meta-data will be shared, along with code books.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_time_frame>Data will be available following publication of results.</ipd_time_frame>
      <ipd_access_criteria>Individuals can access the following signing form from IRB.</ipd_access_criteria>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05985928
  org study id: 2587
  secondary id: R21DC018906
  nct id: NCT05985928
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Researchers will investigate the correlation between a) self-reported dietary intake of foods
        and beverages, b) intensity of sucrose stimuli, and c) liking rating of sweet stimuli, with
        the relative expression of the taste receptor genes from human fungiform papillae (TAS1R2 and
        TAS1R3).
  
        * This research will provide new information on how sweet taste perception is regulated.
  
          -  The hypothesis: Greater dietary consumption of sugar and sweet foods is associated with
             reduced expression of the sweet taste receptors.
  
          -  The results of this study could help to identify pathways to help modify sweet taste
             perception by uncovering this mechanism.
  
        Participants will sample solutions prepared with sweet ingredients, provide salivary DNA, and
        collect fungiform papillae. This will allow researchers and investigators to compare the
        relationship between the sweetness of stimuli, genetic differences in sweet taste receptors,
        and expression levels of sweet taste receptor genes.
  observational model: Other
  time perspective: Other
  measure: Gene expression and sweet taste perception
  time frame: Day 1 (single time-point)
  description: The relative level of gene expression of sweet taste receptors (TAS1R2 and TAS1R3) and relationship with sweet taste perception (gLMS ratings of sampled sucrose)
  measure: Gene expression and sweet taste liking
  time frame: Day 1 (single time-point)
  description: The relative level of gene expression of sweet taste receptors (TAS1R2 and TAS1R3) and relationship with sweet taste perception (hedonic ratings of sampled sucrose)
  measure: Gene expression and dietary intake
  time frame: Day 1 (single time-point)
  description: The relative gene level expression of sweet taste receptors and relationship with self-reported dietary intake of sweet foods and beverages
  measure: Gene expression and sweet liker status
  time frame: Day 1 (single time-point)
  description: The relative gene level expression of sweet taste receptors and relationship with the self-reported liking of a variety of sweet foods and beverages
  measure: Genetics and sweet taste perception
  time frame: Day 1 (single time-point)
  description: Genetic variability in sweet taste receptor genes and the relationship with perception of sweet stimuli (gLMS intensity ratings)
  measure: Genetics and sweet taste liking
  time frame: Day 1 (single time-point)
  description: Genetic variability in sweet taste receptor genes and the relationship with hedonic ratings of sweet stimuli (hedonic ratings)
  measure: Genetics and sweet liker status
  time frame: Day 1 (single time-point)
  description: Genetic variability in sweet taste receptor genes and the relationship with the self-reported liking of sweet-tasting foods and beverages
  saliva, tissue
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 45 Years
  healthy volunteers: No
  facility: 
  country: United States
  responsible party type: Sponsor
  sharing ipd: Yes
  ipd description: Data will be shared at the request, after signing release form. No PHI will be included. All data will be de-identified. Data and meta-data will be shared, along with code books.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Informed Consent Form (ICF)
  ipd time frame: Data will be available following publication of results.
  ipd access criteria: Individuals can access the following signing form from IRB.