<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/NCT02966444</url>
  </required_header>
  <id_info>
    <org_study_id>CT2016JS1</org_study_id>
    <nct_id>NCT02966444</nct_id>
  </id_info>
  <brief_title>Hunger, Satiety, and Metabolic Responses to High-fat Meals of Varying Fatty Acid Composition</brief_title>
  <official_title>Hunger, Satiety, and Metabolic Responses to High-fat Meals of Varying Fatty Acid Composition</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>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study evaluates the effects of dietary fatty acid composition from high fat meals on&#xD;
      markers of hunger, satiety and metabolism.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>October 2016</start_date>
  <completion_date type="Anticipated">July 2018</completion_date>
  <primary_completion_date type="Anticipated">July 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>Crossover Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Peptide-YY</measure>
    <time_frame>18 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Visual Analog Scale</measure>
    <time_frame>18 months</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">16</enrollment>
  <condition>Body Weight Changes</condition>
  <arm_group>
    <arm_group_label>MUFA-rich HF Meal</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>High-fat meal rich in monounsaturated fatty acids</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PUFA-rich HF Meal</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>High-fat meal rich in polyunsaturated fatty acids</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SFA-rich HF Meal</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>High-fat meal rich in saturated fatty acids</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>MUFA-rich HF Meal</intervention_name>
    <arm_group_label>MUFA-rich HF Meal</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>PUFA-rich HF Meal</intervention_name>
    <arm_group_label>PUFA-rich HF Meal</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>SFA-rich HF Meal</intervention_name>
    <arm_group_label>SFA-rich HF Meal</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  BMI of &gt;18.5-24.9kg/m2&#xD;
&#xD;
          -  Woman&#xD;
&#xD;
          -  18-40yrs of age&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Evidence of weight loss or gain exceeding 5% of their body weight within the past 3&#xD;
             months.&#xD;
&#xD;
          -  Plans to lose weight or begin a weight loss program between initiation of study and&#xD;
             final testing.&#xD;
&#xD;
          -  Plans to begin an exercise program or change current exercise routines between&#xD;
             initiation of study and final testing.&#xD;
&#xD;
          -  Is on a medically prescribed diet&#xD;
&#xD;
          -  Does not consume breakfast regularly&#xD;
&#xD;
          -  Rate less than 80% of foods offered in the buffet at 50mm or more on the 100mm VAS as&#xD;
             palatable&#xD;
&#xD;
          -  Medications that could influence appetite or sensory function&#xD;
&#xD;
          -  Reports of metabolic or endocrine disease, gastrointestinal disorders, or history of&#xD;
             medical or surgical events that could affect fat digestion and hormone signaling.&#xD;
&#xD;
          -  Any chronic disease including type II diabetes, hypothyroidism, hyperthyroidism,&#xD;
             cardiovascular disease, and cancer&#xD;
&#xD;
          -  Any supplements that a subject begins taking between initiation of study and final&#xD;
             testing.&#xD;
&#xD;
          -  Anyone who is currently pregnant, lactating, or planning on becoming pregnant before&#xD;
             the conclusion of this study.&#xD;
&#xD;
          -  Anyone who has allergies to any of the components of the liquid meals&#xD;
&#xD;
          -  Anyone who has donated blood in the last 20 days&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jada L Stevenson, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Texas Christian University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jada L Stevenson, PhD</last_name>
    <phone>817-257-6310</phone>
    <email>jada.stevenson@tcu.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Texas Christian University</name>
      <address>
        <city>Fort Worth</city>
        <state>Texas</state>
        <zip>76102</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jada L Stevenson, PhD</last_name>
      <phone>817-257-6310</phone>
      <email>jada.stevenson@tcu.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2018</verification_date>
  <study_first_submitted>November 8, 2016</study_first_submitted>
  <study_first_submitted_qc>November 15, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 17, 2016</study_first_posted>
  <last_update_submitted>July 24, 2018</last_update_submitted>
  <last_update_submitted_qc>July 24, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">July 26, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Texas Christian University</investigator_affiliation>
    <investigator_full_name>Jada Stevenson</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Body Weight</mesh_term>
    <mesh_term>Body Weight Changes</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/NCT02966444
org study id: CT2016JS1
nct id: NCT02966444
lead sponsor: 
has dmc: No
This study evaluates the effects of dietary fatty acid composition from high fat meals on
      markers of hunger, satiety and metabolism.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Prevention
masking: Single (Participant)
measure: Peptide-YY
time frame: 18 months
measure: Visual Analog Scale
time frame: 18 months
arm group label: MUFA-rich HF Meal
arm group type: Experimental
description: High-fat meal rich in monounsaturated fatty acids
arm group label: PUFA-rich HF Meal
arm group type: Experimental
description: High-fat meal rich in polyunsaturated fatty acids
arm group label: SFA-rich HF Meal
arm group type: Experimental
description: High-fat meal rich in saturated fatty acids
intervention type: Other
intervention name: MUFA-rich HF Meal
arm group label: MUFA-rich HF Meal
intervention type: Other
intervention name: PUFA-rich HF Meal
arm group label: PUFA-rich HF Meal
intervention type: Other
intervention name: SFA-rich HF Meal
arm group label: SFA-rich HF Meal
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jada L Stevenson, PhD
role: Principal Investigator
affiliation: Texas Christian University
last name: Jada L Stevenson, PhD
phone: 817-257-6310
email: jada.stevenson@tcu.edu
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Texas Christian University
investigator full name: Jada Stevenson
investigator title: Assistant Professor
mesh term: Body Weight
mesh term: Body Weight Changes
sharing ipd: No