<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/NCT01684553</url>
  </required_header>
  <id_info>
    <org_study_id>F10-39</org_study_id>
    <nct_id>NCT01684553</nct_id>
  </id_info>
  <brief_title>The Effect of Changing the Eating Speed on Energy Intake</brief_title>
  <acronym>EatSpeed</acronym>
  <official_title>The Effect of Changing the Eating Speed on Energy Intake: a Randomized Cross-over Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Texas Christian University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Texas Christian University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      It was hypothesized that eating a meal slowly would lead to a lower meal energy intake and&#xD;
      lesser feelings of hunger and desire to eat and higher levels of fullness after the meal&#xD;
      compared to eating the same meal more quickly.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>February 2011</start_date>
  <completion_date type="Actual">May 2011</completion_date>
  <primary_completion_date type="Actual">May 2011</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>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Meal energy intake</measure>
    <time_frame>Day 1</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Meal energy intake</measure>
    <time_frame>Day 2</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hunger questionnaire</measure>
    <time_frame>0 and 60 min after the meal began</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fullness questionnaire</measure>
    <time_frame>0 and 60 min after the meal began</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Desire to eat questionnaire</measure>
    <time_frame>0 and 60 min after the meal began</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Thirst questionnaire</measure>
    <time_frame>0 and 60 min after the meal began</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">70</enrollment>
  <condition>Oral Intake Reduced</condition>
  <arm_group>
    <arm_group_label>Slow eating condition</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The subjects were asked to eat their meal slowly during the slow eating condition</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Fast eating condition</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The subjects were asked to eat their meal quickly during the fast eating condition</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Slow eating condition</intervention_name>
    <description>The subjects were asked to eat their meal slowly during the slow eating condition</description>
    <arm_group_label>Slow eating condition</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Fast eating condition</intervention_name>
    <description>The subjects were asked to eat their meal quickly during the fast eating condition</description>
    <arm_group_label>Fast eating condition</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men and women ages 19-65 years.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe obesity (BMI ≥ 40 kg/m2),&#xD;
&#xD;
          -  dieting,&#xD;
&#xD;
          -  taking medications that affect appetite,&#xD;
&#xD;
          -  participating in &gt; 150 min/wk of vigorous physical activity,&#xD;
&#xD;
          -  smoking,&#xD;
&#xD;
          -  drinking heavily (men: &gt; 14 alcoholic drinks/wk; women: &gt; 7 alcoholic drinks/wk),&#xD;
&#xD;
          -  self-reported disordered eating,&#xD;
&#xD;
          -  depression,&#xD;
&#xD;
          -  type 1 or 2 diabetes,&#xD;
&#xD;
          -  adrenal disease, or&#xD;
&#xD;
          -  untreated thyroid disease.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Meena Shah, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Tzu Chi University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Texas Christian University</name>
      <address>
        <city>Fort Worth</city>
        <state>Texas</state>
        <zip>76129</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>September 5, 2012</study_first_submitted>
  <study_first_submitted_qc>September 12, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 13, 2012</study_first_posted>
  <last_update_submitted>September 12, 2012</last_update_submitted>
  <last_update_submitted_qc>September 12, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 13, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Texas Christian University</investigator_affiliation>
    <investigator_full_name>Meena Shah</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Eating speed</keyword>
  <keyword>energy intake</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/NCT01684553
org study id: F10-39
nct id: NCT01684553
lead sponsor: 
has dmc: Yes
It was hypothesized that eating a meal slowly would lead to a lower meal energy intake and
      lesser feelings of hunger and desire to eat and higher levels of fullness after the meal
      compared to eating the same meal more quickly.
allocation: Randomized
intervention model: Crossover Assignment
masking: Single (Participant)
measure: Meal energy intake
time frame: Day 1
measure: Meal energy intake
time frame: Day 2
measure: Hunger questionnaire
time frame: 0 and 60 min after the meal began
measure: Fullness questionnaire
time frame: 0 and 60 min after the meal began
measure: Desire to eat questionnaire
time frame: 0 and 60 min after the meal began
measure: Thirst questionnaire
time frame: 0 and 60 min after the meal began
arm group label: Slow eating condition
arm group type: Experimental
description: The subjects were asked to eat their meal slowly during the slow eating condition
arm group label: Fast eating condition
arm group type: Active Comparator
description: The subjects were asked to eat their meal quickly during the fast eating condition
intervention type: Behavioral
intervention name: Slow eating condition
description: The subjects were asked to eat their meal slowly during the slow eating condition
arm group label: Slow eating condition
intervention type: Behavioral
intervention name: Fast eating condition
description: The subjects were asked to eat their meal quickly during the fast eating condition
arm group label: Fast eating condition
criteria: 
gender: All
minimum age: 19 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Meena Shah, Ph.D.
role: Principal Investigator
affiliation: Tzu Chi University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Texas Christian University
investigator full name: Meena Shah
investigator title: Professor