<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/NCT03010930</url>
  </required_header>
  <id_info>
    <org_study_id>1608006563</org_study_id>
    <nct_id>NCT03010930</nct_id>
  </id_info>
  <brief_title>Repeated Exposure to Umami Taste on Taste Perception, Hedonics, and Satiety</brief_title>
  <official_title>Does Repeated Dietary Exposure to Umami Taste Affect Umami Perception, Hedonics, or Satiety? A Randomized Controlled Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cornell University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cornell University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine how repeated dietary exposure to umami taste&#xD;
      affects umami taste perception, hedonics, food preferences, and satiety. Healthy adult&#xD;
      subjects will consume a low glutamate vegetable broth daily for one month, where the&#xD;
      experimental group's broth is supplemented with the umami-rich stimuli of monosodium&#xD;
      glutamate (MSG) and the control group's low glutamate broth is matched for sodium (NaCl).&#xD;
&#xD;
      The investigators hypothesize that repeated dietary exposure to umami taste will:&#xD;
&#xD;
        1. diminish umami suprathreshold intensity perception and hinder the ability to&#xD;
           discriminate varying MSG concentrations&#xD;
&#xD;
        2. decrease liking of umami-rich foods and shift preferences upwards towards more intense&#xD;
           umami stimuli&#xD;
&#xD;
        3. decrease satiation and decrease the satiating effect of a test meal&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2016</start_date>
  <completion_date type="Actual">November 2016</completion_date>
  <primary_completion_date type="Actual">November 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in umami taste intensity perception</measure>
    <time_frame>1 month (at baseline and post intervention)</time_frame>
    <description>Subjects rate the umami intensity of aqueous solutions and foods on the general Labeled Magnitude Scale before and after a month-long dietary supplementation to determine how perception changes with repeated exposure to umami taste</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in umami taste discrimination</measure>
    <time_frame>1 month (at baseline and post intervention)</time_frame>
    <description>Subjects rank solutions of varying umami intensity before and after a month-long dietary supplementation to determine how perception changes with repeated exposure to umami taste</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in umami liking and preference</measure>
    <time_frame>1 month (at baseline and post intervention)</time_frame>
    <description>Subjects rate liking and preference in a variety of umami-rich foods before and after a month-long dietary supplementation to determine how liking and preference of umami-rich foods changes with repeated exposure to umami taste</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in liking and wanting of high protein foods</measure>
    <time_frame>1 month (at baseline and post intervention)</time_frame>
    <description>Subjects complete the Leeds Food Preference Questionnaire before and after a month-long dietary supplementation to determine how explicit liking and implicit wanting of high-protein foods changes with repeated exposure to umami taste</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in satiation</measure>
    <time_frame>1 month (at baseline and post intervention)</time_frame>
    <description>Subjects consume a test meal and the amount of food eaten is measured before and after a month-long dietary supplementation to determine how satiation from a test meal differs after repeated exposure to umami taste</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in satiety</measure>
    <time_frame>1 month (at baseline and post intervention)</time_frame>
    <description>Subjects consume a test meal and rate appetite sensations on a visual analog scale throughout the test meal before and after a month-long dietary supplementation. A satiety quotient will be derived from these values with the formula: Satiety Quotient = (rating pre-eating episode-rating post-eating episode) / (intake of eating episode) to determine how satiety changes with repeated exposure to umami taste</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Height</measure>
    <time_frame>1 month (at baseline and post intervention)</time_frame>
    <description>Body height (centimeters) will be measured with standard procedures and equipment. Using this information, BMI will be calculated with the formula: BMI=[kg/m]2 to ensure that BMI does not change with repeated exposure to umami taste</description>
  </other_outcome>
  <other_outcome>
    <measure>Weight</measure>
    <time_frame>1 month (at baseline and post intervention)</time_frame>
    <description>Body weight (kilograms) will be measured with standard procedures and equipment. Using this information, BMI will be calculated with the formula: BMI=[kg/m]2 to ensure that BMI does not change with repeated exposure to umami taste</description>
  </other_outcome>
  <other_outcome>
    <measure>Habitual glutamate consumption</measure>
    <time_frame>1 month (at baseline and post intervention)</time_frame>
    <description>Subjects complete the National Cancer Institute's monthly diet history questionnaire to estimate habitual glutamate consumption. Baseline habitual glutamate consumption, in addition to gender, will be assessed as effect modifiers in the analysis.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">64</enrollment>
  <condition>Umami Taste Perception</condition>
  <arm_group>
    <arm_group_label>Increased exposure to MSG</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects consume vegetable broth daily containing MSG</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No change in exposure to MSG</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Subjects consume low glutamate vegetable broth daily, sodium-matched to the broth of the experimental group with NaCl</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Supplementation of diet with MSG</intervention_name>
    <description>Subjects eat normal diet and consume 8 ounces of vegetable broth with added MSG one time per day for 1 month</description>
    <arm_group_label>Increased exposure to MSG</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No supplementation of diet with MSG</intervention_name>
    <description>Subjects eat normal diet and consume 8 ounces of low glutamate vegetable broth without MSG (sodium-matched with NaCl) one time per day for 1 month</description>
    <arm_group_label>No change in exposure to MSG</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Have normal sense of taste and smell (self-report)&#xD;
&#xD;
          -  Likes soups or broths (self-report)&#xD;
&#xD;
          -  Able to report to study site daily (self-report)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Restrained eater (score &gt; 12 on restrained eating subscale from Three Factor Eating&#xD;
             Questionnaire)&#xD;
&#xD;
          -  BMI &lt; 18 or &gt; 25 kg/m2 (self-report)&#xD;
&#xD;
          -  Vegan (self-report)&#xD;
&#xD;
          -  Hypertensive or on low-sodium diet (self-report)&#xD;
&#xD;
          -  Allergic or sensitive to MSG (self-report)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>December 15, 2016</study_first_submitted>
  <study_first_submitted_qc>January 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 5, 2017</study_first_posted>
  <last_update_submitted>January 24, 2022</last_update_submitted>
  <last_update_submitted_qc>January 24, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 7, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03010930
org study id: 1608006563
nct id: NCT03010930
lead sponsor: 
has dmc: No
The purpose of this study is to determine how repeated dietary exposure to umami taste
      affects umami taste perception, hedonics, food preferences, and satiety. Healthy adult
      subjects will consume a low glutamate vegetable broth daily for one month, where the
      experimental group's broth is supplemented with the umami-rich stimuli of monosodium
      glutamate (MSG) and the control group's low glutamate broth is matched for sodium (NaCl).

      The investigators hypothesize that repeated dietary exposure to umami taste will:

        1. diminish umami suprathreshold intensity perception and hinder the ability to
           discriminate varying MSG concentrations

        2. decrease liking of umami-rich foods and shift preferences upwards towards more intense
           umami stimuli

        3. decrease satiation and decrease the satiating effect of a test meal
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Single (Participant)
measure: Change in umami taste intensity perception
time frame: 1 month (at baseline and post intervention)
description: Subjects rate the umami intensity of aqueous solutions and foods on the general Labeled Magnitude Scale before and after a month-long dietary supplementation to determine how perception changes with repeated exposure to umami taste
measure: Change in umami taste discrimination
time frame: 1 month (at baseline and post intervention)
description: Subjects rank solutions of varying umami intensity before and after a month-long dietary supplementation to determine how perception changes with repeated exposure to umami taste
measure: Change in umami liking and preference
time frame: 1 month (at baseline and post intervention)
description: Subjects rate liking and preference in a variety of umami-rich foods before and after a month-long dietary supplementation to determine how liking and preference of umami-rich foods changes with repeated exposure to umami taste
measure: Change in liking and wanting of high protein foods
time frame: 1 month (at baseline and post intervention)
description: Subjects complete the Leeds Food Preference Questionnaire before and after a month-long dietary supplementation to determine how explicit liking and implicit wanting of high-protein foods changes with repeated exposure to umami taste
measure: Change in satiation
time frame: 1 month (at baseline and post intervention)
description: Subjects consume a test meal and the amount of food eaten is measured before and after a month-long dietary supplementation to determine how satiation from a test meal differs after repeated exposure to umami taste
measure: Change in satiety
time frame: 1 month (at baseline and post intervention)
description: Subjects consume a test meal and rate appetite sensations on a visual analog scale throughout the test meal before and after a month-long dietary supplementation. A satiety quotient will be derived from these values with the formula: Satiety Quotient = (rating pre-eating episode-rating post-eating episode) / (intake of eating episode) to determine how satiety changes with repeated exposure to umami taste
measure: Height
time frame: 1 month (at baseline and post intervention)
description: Body height (centimeters) will be measured with standard procedures and equipment. Using this information, BMI will be calculated with the formula: BMI=[kg/m]2 to ensure that BMI does not change with repeated exposure to umami taste
measure: Weight
time frame: 1 month (at baseline and post intervention)
description: Body weight (kilograms) will be measured with standard procedures and equipment. Using this information, BMI will be calculated with the formula: BMI=[kg/m]2 to ensure that BMI does not change with repeated exposure to umami taste
measure: Habitual glutamate consumption
time frame: 1 month (at baseline and post intervention)
description: Subjects complete the National Cancer Institute's monthly diet history questionnaire to estimate habitual glutamate consumption. Baseline habitual glutamate consumption, in addition to gender, will be assessed as effect modifiers in the analysis.
arm group label: Increased exposure to MSG
arm group type: Experimental
description: Subjects consume vegetable broth daily containing MSG
arm group label: No change in exposure to MSG
arm group type: Sham Comparator
description: Subjects consume low glutamate vegetable broth daily, sodium-matched to the broth of the experimental group with NaCl
intervention type: Other
intervention name: Supplementation of diet with MSG
description: Subjects eat normal diet and consume 8 ounces of vegetable broth with added MSG one time per day for 1 month
arm group label: Increased exposure to MSG
intervention type: Other
intervention name: No supplementation of diet with MSG
description: Subjects eat normal diet and consume 8 ounces of low glutamate vegetable broth without MSG (sodium-matched with NaCl) one time per day for 1 month
arm group label: No change in exposure to MSG
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Sponsor
sharing ipd: No