<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/NCT03043118</url>
  </required_header>
  <id_info>
    <org_study_id>ChildrensTasteStudy</org_study_id>
    <nct_id>NCT03043118</nct_id>
  </id_info>
  <brief_title>Children's Taste Study to Increase Vegetable Intake in Preschoolers</brief_title>
  <acronym>CTS</acronym>
  <official_title>A Pilot Study to Test the Influence of Vegetable Flavor Variety Using Herbs and Spices on Preschool Children's Vegetable Intake</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Penn State University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Penn State University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Studies have shown that when exposed to a variety of food and flavor options people tend to&#xD;
      consume more than when only one item is presented. This strategy has been used to increase&#xD;
      vegetable intake in adults and during snacktime in children. Increasing vegetable consumption&#xD;
      in children is important because higher vegetable intake has been associated with reduced&#xD;
      risk of disease and because vegetables can help prevent weight gain by lowering the energy&#xD;
      density of a meal. The purpose of this study was to investigate the effects of using herb and&#xD;
      spice blends to create flavor variety in carrots as a model vegetable in a laboratory test&#xD;
      meal. We predict that children will consume more vegetables and that the energy density of&#xD;
      the meal will be lower when a variety of seasoned carrots are presented in comparison to a&#xD;
      single flavor. A secondary goal of the study was to determine other influences that may&#xD;
      predict children's liking and intake of seasoned vegetables, such as previous exposure,&#xD;
      infant feeding practices, and genetic bitter sensitivity.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 2015</start_date>
  <completion_date type="Actual">November 2, 2016</completion_date>
  <primary_completion_date type="Actual">November 2, 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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Chang in Vegetable Intake</measure>
    <time_frame>Baseline and 1 week</time_frame>
    <description>Consumption is measured by pre- and post- weights of carrot offered in both the variety and no variety conditions</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Total Food Intake</measure>
    <time_frame>Baseline and 1 week</time_frame>
    <description>Consumption is measured by pre- and post- weights of all meal items offered in both the variety and no variety conditions</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Meal Energy Density</measure>
    <time_frame>Baseline and 1 week</time_frame>
    <description>Calculated from the total calories consumed divided by the grams of food eaten</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Spice Intake Questionnaire</measure>
    <time_frame>Baseline</time_frame>
    <description>A survey of maternally reported herb and spice consumption during pregnancy and breastfeeding as well as current home use</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Home Spice Checklist</measure>
    <time_frame>Baseline</time_frame>
    <description>A comprehensive checklist of 34 herbs and spices for parents to fill out at home to evaluate children's overall herb and spice exposure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infant Feeding Practices</measure>
    <time_frame>Baseline</time_frame>
    <description>A survey of maternally reported feeding practices, include breastfeeding, formula feeding, and introduction to solid foods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Liking of Broccoli with Herbs and Spices</measure>
    <time_frame>Baseline</time_frame>
    <description>Liking is measured using a child friendly 5-pt hedonic scale; pilot data for future studies looking to apply this technique to green vegetables</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Liking of Carrots with Herb and Spice Blends</measure>
    <time_frame>Baseline</time_frame>
    <description>Liking is measured using a child friendly 5-pt hedonic scale</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Age</measure>
    <time_frame>Baseline</time_frame>
    <description>Age of the participant on visit 1</description>
  </other_outcome>
  <other_outcome>
    <measure>Height</measure>
    <time_frame>Baseline</time_frame>
    <description>Height measured in cm on a stadiometer</description>
  </other_outcome>
  <other_outcome>
    <measure>Weight</measure>
    <time_frame>Baseline</time_frame>
    <description>Weight measured to the 0.1 pounds using a digital scale</description>
  </other_outcome>
  <other_outcome>
    <measure>6-n-propylthiourcacil Sensitivity</measure>
    <time_frame>Baseline</time_frame>
    <description>Children switch and spit a 56 umol solution of 6-n-propylthiouracil and are classified as tasters if it described as &quot;bitter&quot; or &quot;yucky&quot; and non-tasters if it's described as &quot;nothing&quot; or &quot;like water&quot;.</description>
  </other_outcome>
  <other_outcome>
    <measure>Body Mass Index</measure>
    <time_frame>Baseline</time_frame>
    <description>Calculated from height and weight (kg/m^2)</description>
  </other_outcome>
  <other_outcome>
    <measure>Children's Eating Behavior Questionnaire</measure>
    <time_frame>Baseline</time_frame>
    <description>A validated parent-reported questionnaire on children's typical eating behaviors and attitudes toward foods</description>
  </other_outcome>
  <other_outcome>
    <measure>Preschool Adjusted Liking Scale</measure>
    <time_frame>Baseline</time_frame>
    <description>A questionnaire to assess children's liking of various common foods and daily activities.</description>
  </other_outcome>
  <other_outcome>
    <measure>Family Demographics</measure>
    <time_frame>Baseline</time_frame>
    <description>A parent-reported questionnaire</description>
  </other_outcome>
  <other_outcome>
    <measure>Parental Feeding Practices</measure>
    <time_frame>Baseline</time_frame>
    <description>A parent-reported questionnaire on typical feeding practices</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">48</enrollment>
  <condition>Pediatric Obesity</condition>
  <arm_group>
    <arm_group_label>Variety</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Children receive three servings of vegetables each prepared with a different herb and spice blend.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No Variety - Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Children receive three servings of vegetables each prepared with the same herb and spice blend.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Variety Intervention</intervention_name>
    <description>Vegetable flavor variety created with multiple herb and spice blends</description>
    <arm_group_label>Variety</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Acceptance of test meal foods&#xD;
&#xD;
          -  Generally healthy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Food allergies&#xD;
&#xD;
          -  Medications (prescription or OTC) that can affect taste, smell or appetite&#xD;
&#xD;
          -  Medical conditions&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>5 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kathleen L Keller, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Pennsylvania State University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Pennsylvania State University</name>
      <address>
        <city>University Park</city>
        <state>Pennsylvania</state>
        <zip>16802</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>October 6, 2016</study_first_submitted>
  <study_first_submitted_qc>February 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 3, 2017</study_first_posted>
  <last_update_submitted>April 4, 2022</last_update_submitted>
  <last_update_submitted_qc>April 4, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 5, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Penn State University</investigator_affiliation>
    <investigator_full_name>Kathleen Loralee Keller</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Eating Behaviors</keyword>
  <keyword>Preschool</keyword>
  <keyword>Vegetable Intake</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pediatric Obesity</mesh_term>
  </condition_browse>
  <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/NCT03043118
org study id: ChildrensTasteStudy
nct id: NCT03043118
lead sponsor: 
has dmc: No
Studies have shown that when exposed to a variety of food and flavor options people tend to
      consume more than when only one item is presented. This strategy has been used to increase
      vegetable intake in adults and during snacktime in children. Increasing vegetable consumption
      in children is important because higher vegetable intake has been associated with reduced
      risk of disease and because vegetables can help prevent weight gain by lowering the energy
      density of a meal. The purpose of this study was to investigate the effects of using herb and
      spice blends to create flavor variety in carrots as a model vegetable in a laboratory test
      meal. We predict that children will consume more vegetables and that the energy density of
      the meal will be lower when a variety of seasoned carrots are presented in comparison to a
      single flavor. A secondary goal of the study was to determine other influences that may
      predict children's liking and intake of seasoned vegetables, such as previous exposure,
      infant feeding practices, and genetic bitter sensitivity.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Chang in Vegetable Intake
time frame: Baseline and 1 week
description: Consumption is measured by pre- and post- weights of carrot offered in both the variety and no variety conditions
measure: Change in Total Food Intake
time frame: Baseline and 1 week
description: Consumption is measured by pre- and post- weights of all meal items offered in both the variety and no variety conditions
measure: Change in Meal Energy Density
time frame: Baseline and 1 week
description: Calculated from the total calories consumed divided by the grams of food eaten
measure: Spice Intake Questionnaire
time frame: Baseline
description: A survey of maternally reported herb and spice consumption during pregnancy and breastfeeding as well as current home use
measure: Home Spice Checklist
time frame: Baseline
description: A comprehensive checklist of 34 herbs and spices for parents to fill out at home to evaluate children's overall herb and spice exposure
measure: Infant Feeding Practices
time frame: Baseline
description: A survey of maternally reported feeding practices, include breastfeeding, formula feeding, and introduction to solid foods.
measure: Liking of Broccoli with Herbs and Spices
time frame: Baseline
description: Liking is measured using a child friendly 5-pt hedonic scale; pilot data for future studies looking to apply this technique to green vegetables
measure: Liking of Carrots with Herb and Spice Blends
time frame: Baseline
description: Liking is measured using a child friendly 5-pt hedonic scale
measure: Age
time frame: Baseline
description: Age of the participant on visit 1
measure: Height
time frame: Baseline
description: Height measured in cm on a stadiometer
measure: Weight
time frame: Baseline
description: Weight measured to the 0.1 pounds using a digital scale
measure: 6-n-propylthiourcacil Sensitivity
time frame: Baseline
description: Children switch and spit a 56 umol solution of 6-n-propylthiouracil and are classified as tasters if it described as "bitter" or "yucky" and non-tasters if it's described as "nothing" or "like water".
measure: Body Mass Index
time frame: Baseline
description: Calculated from height and weight (kg/m^2)
measure: Children's Eating Behavior Questionnaire
time frame: Baseline
description: A validated parent-reported questionnaire on children's typical eating behaviors and attitudes toward foods
measure: Preschool Adjusted Liking Scale
time frame: Baseline
description: A questionnaire to assess children's liking of various common foods and daily activities.
measure: Family Demographics
time frame: Baseline
description: A parent-reported questionnaire
measure: Parental Feeding Practices
time frame: Baseline
description: A parent-reported questionnaire on typical feeding practices
arm group label: Variety
arm group type: Experimental
description: Children receive three servings of vegetables each prepared with a different herb and spice blend.
arm group label: No Variety - Control
arm group type: No Intervention
description: Children receive three servings of vegetables each prepared with the same herb and spice blend.
intervention type: Other
intervention name: Variety Intervention
description: Vegetable flavor variety created with multiple herb and spice blends
arm group label: Variety
criteria: 
gender: All
minimum age: 3 Years
maximum age: 5 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Kathleen L Keller, Ph.D.
role: Principal Investigator
affiliation: The Pennsylvania State University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Penn State University
investigator full name: Kathleen Loralee Keller
investigator title: Assistant Professor
mesh term: Pediatric Obesity
sharing ipd: No