<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/NCT02198911</url>
  </required_header>
  <id_info>
    <org_study_id>9212-B</org_study_id>
    <nct_id>NCT02198911</nct_id>
  </id_info>
  <brief_title>The Effects of Chewing Gum on a Computer Task and Liking Ratings of Ice Cream</brief_title>
  <official_title>The Effects of Chewing Gum on a Computer Task and Liking Ratings of Ice Cream</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The University of Tennessee, Knoxville</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The University of Tennessee, Knoxville</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to examine if chewing gum before an eating bout will increase&#xD;
      the rate of habituation and subsequently reduce energy intake within the eating bout.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Approximately two-thirds of U.S. adults are overweight or obese, thus placing obesity first&#xD;
      as a public health concern in the U.S. Not only is obesity detrimental at the individual&#xD;
      level, by increasing risk for chronic disease and premature mortality, but it also presents&#xD;
      problems at the economical level by increasing medical costs.&#xD;
&#xD;
      At the heart of weight management is the ability to appropriately regulate energy intake. A&#xD;
      key factor in regulation of consumption is satiation, the process by which an eating bout&#xD;
      ends. Quicker onset of satiation may result in decreased consumption, which is important in&#xD;
      achieving an adequate energy balance. Negative energy balance, in which energy intake is less&#xD;
      than energy expenditure, is required for weight loss; however, there are challenges with&#xD;
      increased hunger and decreased satiation as energy intake is decreased.&#xD;
&#xD;
      One of the factors believed to influence satiation is the ability to increase the rate of&#xD;
      habituation occurring during an eating bout. Habituation is a basic form of learning that can&#xD;
      be measured by the rate of decrease in consummatory response to repeated presentations of&#xD;
      food orosensory cues. Following this decreased response rate to a particular food,&#xD;
      presentation of new orosensory cues may result in dishabituation to both the previously&#xD;
      habituated food as well as the new orosensory cue, thus causing an increase in consummatory&#xD;
      response. Dishabituation during an eating bout, i.e. exposure to a variety of orosensory&#xD;
      cues, may be related to recovery of appetite and decreased satiation, leading the&#xD;
      calorie-replete individual to overconsume. Alternatively, with repeated presentations of the&#xD;
      same orosensory cue, one becomes accustomed to the taste faster, giving rise to habituation,&#xD;
      which should increase satiation. A more rapid rate of habituation would mean that less energy&#xD;
      is consumed within an eating bout. Research indicates increased weight status in relation to&#xD;
      slower habituation rates as well as an inverse relationship between the extent of orosensory&#xD;
      variety and habituation rates. Additionally, research shows a positive association between&#xD;
      amount of orosensory cues and amount consumed within an eating bout.&#xD;
&#xD;
      One way to provide a single orosensory cue and initiate enhanced habituation with a minimal&#xD;
      amount of additional energy intake is by chewing sugar-free, flavored gum. If matched to the&#xD;
      flavor of the food about to be consumed, chewing gum prior to an eating bout may increase the&#xD;
      rate of habituation, consequently reducing consumption.&#xD;
&#xD;
      Therefore, the purpose of this proof-of-concept study is to examine if chewing gum before an&#xD;
      eating bout will increase the rate of habituation and subsequently reduce energy intake&#xD;
      within the eating bout. The outcomes of this study may be useful in the health setting for&#xD;
      creating prescriptions for weight-loss, weight maintenance, and weight-gain prevention.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">June 2013</start_date>
  <completion_date type="Anticipated">December 31, 2024</completion_date>
  <primary_completion_date type="Actual">December 31, 2018</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>Factorial Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Grams of ice cream eaten</measure>
    <time_frame>3 trials (60 minutes)</time_frame>
    <description>Amount of ice cream consumed will be measured using the following formula: amount of ice cream before consumption (first weight) - amount of ice cream following consumption (second weight). Grams of ice cream consumed will be determined following each 60 minute session (1, 2, and 3).</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Habituation</condition>
  <arm_group>
    <arm_group_label>Order 1</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Gum chewing order for sessions, 1-3 respectively: NO GUM, MCC, C</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Order 2</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Gum chewing order for ice-cream sessions, 1-3 respectively: MCC, C, NO GUM</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Order 3</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Gum chewing order for ice-cream sessions, 1-3 respectively: C, NO GUM, MCC</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>NO GUM</intervention_name>
    <description>For the NO GUM condition, participants will not chew gum before engaging in a computer task that will allow participants to earn points for MCC ice cream that they can consume.</description>
    <arm_group_label>Order 1</arm_group_label>
    <arm_group_label>Order 2</arm_group_label>
    <arm_group_label>Order 3</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>MCC (Mint Chocolate Chip gum)</intervention_name>
    <description>For the MCC gum condition, participants will chew MCC gum before engaging in a computer task that will allow participants to earn points for MCC ice cream that they can consume.</description>
    <arm_group_label>Order 1</arm_group_label>
    <arm_group_label>Order 2</arm_group_label>
    <arm_group_label>Order 3</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>C (Cinnamon gum)</intervention_name>
    <description>For the C gum condition, participants will chew Cinnamon gum before engaging in a computer task that will allow participants to earn points for MCC ice cream that they can consume.</description>
    <arm_group_label>Order 1</arm_group_label>
    <arm_group_label>Order 2</arm_group_label>
    <arm_group_label>Order 3</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age between 18 and 40 years&#xD;
&#xD;
          -  of normal weight (body mass index [BMI] between 18.5 and 24.9 kg/m2)&#xD;
&#xD;
          -  unrestrained eater (scoring less than/equal to 12 on the restraint scale of the Three&#xD;
             Factor Eating Questionnaire [TFEQ15])&#xD;
&#xD;
          -  non-smoker (not having smoked or used tobacco products for a year or more)&#xD;
&#xD;
          -  like and are willing to eat (greater than/equal to 50mm on a 100mm visual analogue&#xD;
             scale [VAS]) MCC ice cream&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  have any health condition that requires a specific dietary prescription (i.e.,&#xD;
             diabetes)&#xD;
&#xD;
          -  are unable to chew the gum for the time required in the investigation; 3) do not like&#xD;
             the flavors of gum used in the investigation&#xD;
&#xD;
          -  are allergic to any ingredients in the foods used in the investigation&#xD;
&#xD;
          -  are lactose-intolerant&#xD;
&#xD;
          -  plan to make any changes in dietary intake or physical activity over the course of the&#xD;
             study&#xD;
&#xD;
          -  score &gt;20 on the Eating Attitudes Test (EAT8)&#xD;
&#xD;
          -  score &gt;16 on the Binge Eating Scale (BES10)&#xD;
&#xD;
          -  are not able to stay within the metropolitan area within the time frame of the&#xD;
             investigation&#xD;
&#xD;
          -  are pregnant, lactating, or plan to become pregnant during the investigation&#xD;
&#xD;
          -  are taking any type of medication that influences appetite.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Healthy Eating and Activity Labroatory, University of Tennessee, Knoxville</name>
      <address>
        <city>Knoxville</city>
        <state>Tennessee</state>
        <zip>37996</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>March 25, 2014</study_first_submitted>
  <study_first_submitted_qc>July 22, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 24, 2014</study_first_posted>
  <last_update_submitted>June 17, 2023</last_update_submitted>
  <last_update_submitted_qc>June 17, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 22, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The University of Tennessee, Knoxville</investigator_affiliation>
    <investigator_full_name>Hollie Raynor</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Habituation</keyword>
  <keyword>Orosensory cues</keyword>
  <keyword>Satiation</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/NCT02198911
org study id: 9212-B
nct id: NCT02198911
lead sponsor: 
has dmc: Yes
The purpose of this study is to examine if chewing gum before an eating bout will increase
      the rate of habituation and subsequently reduce energy intake within the eating bout.
Approximately two-thirds of U.S. adults are overweight or obese, thus placing obesity first
      as a public health concern in the U.S. Not only is obesity detrimental at the individual
      level, by increasing risk for chronic disease and premature mortality, but it also presents
      problems at the economical level by increasing medical costs.

      At the heart of weight management is the ability to appropriately regulate energy intake. A
      key factor in regulation of consumption is satiation, the process by which an eating bout
      ends. Quicker onset of satiation may result in decreased consumption, which is important in
      achieving an adequate energy balance. Negative energy balance, in which energy intake is less
      than energy expenditure, is required for weight loss; however, there are challenges with
      increased hunger and decreased satiation as energy intake is decreased.

      One of the factors believed to influence satiation is the ability to increase the rate of
      habituation occurring during an eating bout. Habituation is a basic form of learning that can
      be measured by the rate of decrease in consummatory response to repeated presentations of
      food orosensory cues. Following this decreased response rate to a particular food,
      presentation of new orosensory cues may result in dishabituation to both the previously
      habituated food as well as the new orosensory cue, thus causing an increase in consummatory
      response. Dishabituation during an eating bout, i.e. exposure to a variety of orosensory
      cues, may be related to recovery of appetite and decreased satiation, leading the
      calorie-replete individual to overconsume. Alternatively, with repeated presentations of the
      same orosensory cue, one becomes accustomed to the taste faster, giving rise to habituation,
      which should increase satiation. A more rapid rate of habituation would mean that less energy
      is consumed within an eating bout. Research indicates increased weight status in relation to
      slower habituation rates as well as an inverse relationship between the extent of orosensory
      variety and habituation rates. Additionally, research shows a positive association between
      amount of orosensory cues and amount consumed within an eating bout.

      One way to provide a single orosensory cue and initiate enhanced habituation with a minimal
      amount of additional energy intake is by chewing sugar-free, flavored gum. If matched to the
      flavor of the food about to be consumed, chewing gum prior to an eating bout may increase the
      rate of habituation, consequently reducing consumption.

      Therefore, the purpose of this proof-of-concept study is to examine if chewing gum before an
      eating bout will increase the rate of habituation and subsequently reduce energy intake
      within the eating bout. The outcomes of this study may be useful in the health setting for
      creating prescriptions for weight-loss, weight maintenance, and weight-gain prevention.
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Basic Science
masking: Single (Participant)
measure: Grams of ice cream eaten
time frame: 3 trials (60 minutes)
description: Amount of ice cream consumed will be measured using the following formula: amount of ice cream before consumption (first weight) - amount of ice cream following consumption (second weight). Grams of ice cream consumed will be determined following each 60 minute session (1, 2, and 3).
arm group label: Order 1
arm group type: Active Comparator
description: Gum chewing order for sessions, 1-3 respectively: NO GUM, MCC, C
arm group label: Order 2
arm group type: Active Comparator
description: Gum chewing order for ice-cream sessions, 1-3 respectively: MCC, C, NO GUM
arm group label: Order 3
arm group type: Active Comparator
description: Gum chewing order for ice-cream sessions, 1-3 respectively: C, NO GUM, MCC
intervention type: Other
intervention name: NO GUM
description: For the NO GUM condition, participants will not chew gum before engaging in a computer task that will allow participants to earn points for MCC ice cream that they can consume.
arm group label: Order 1
arm group label: Order 2
arm group label: Order 3
intervention type: Other
intervention name: MCC (Mint Chocolate Chip gum)
description: For the MCC gum condition, participants will chew MCC gum before engaging in a computer task that will allow participants to earn points for MCC ice cream that they can consume.
arm group label: Order 1
arm group label: Order 2
arm group label: Order 3
intervention type: Other
intervention name: C (Cinnamon gum)
description: For the C gum condition, participants will chew Cinnamon gum before engaging in a computer task that will allow participants to earn points for MCC ice cream that they can consume.
arm group label: Order 1
arm group label: Order 2
arm group label: Order 3
criteria: 
gender: All
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: The University of Tennessee, Knoxville
investigator full name: Hollie Raynor
investigator title: Professor