<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/NCT04440826</url>
  </required_header>
  <id_info>
    <org_study_id>1502-441</org_study_id>
    <nct_id>NCT04440826</nct_id>
  </id_info>
  <brief_title>Thermic Effect of Three Different Meals in Healthy Women</brief_title>
  <official_title>Dietary Induced Thermogenic Differences After Consumption of an Unrefined Meal, a Gluten-free Meal, and a Highly Processed Meal</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Skidmore College</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Skidmore College</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will investigate the acute effect of three isocaloric meals varying in level of&#xD;
      food processing, including a whole foods, gluten-free, and highly processed meal on energy&#xD;
      metabolism and blood glucose in 8-12 young adult, normal weight females. A secondary aim of&#xD;
      this proposed study is to compare palatability, satiety, and perceived energy ratings among&#xD;
      highly processed, unrefined, and gluten-free unrefined isocaloric meals.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A shift towards a diet containing large quantities of highly processed foods is believed to&#xD;
      be a major contributor to the trends in obesity. The degree of processing of foods often&#xD;
      affects the nutritional content of the constituents. A reduction in macromolecular complexity&#xD;
      allows for an increased rate of digestion, meaning that the body does not have to work as&#xD;
      hard to metabolize high processed food products. Thus, the purpose of this study is to&#xD;
      investigate the effect on energy metabolism and blood glucose after the consumption of an&#xD;
      unrefined, whole foods meal versus two highly processed food meals, including a common&#xD;
      Western style meal and gluten-free meal in 8-12 young adult, normal weight females. A&#xD;
      secondary aim of this proposed study is to compare palatability, satiety, and perceived&#xD;
      energy ratings among highly processed, unrefined, and gluten-free unrefined isocaloric meals.&#xD;
      It is hypothesized that an unrefined meal will induce a greater postprandial thermogenic&#xD;
      response and a smaller blood glucose response than a highly processed or gluten-free meal.&#xD;
      Additionally, it is hypothesized that a highly processed foods meal will be considered more&#xD;
      palatable than an unrefined or gluten-free meal.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 23, 2015</start_date>
  <completion_date type="Actual">May 30, 2015</completion_date>
  <primary_completion_date type="Actual">May 30, 2015</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Thermic Effect of Meals (TEM) also known as Postprandial Thermogenesis</measure>
    <time_frame>TEM; 45-60; 105-120; and 165-180 minutes after meal ingestion</time_frame>
    <description>The total amount of calories burned after each meal will be measured using indirect calorimetry with the ventilated hood technique. Specifically, the thermic effect of each meal will be measured for a total of three hours at 45 minute intervals for 15 minutes at a time (45-60; 105-120; and 165-180 minutes)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Blood Glucose Response</measure>
    <time_frame>Baseline line 0 minutes, and 60, 120, 180 minutes postprandial</time_frame>
    <description>Change in postprandial blood glucose compared baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Hunger and Palatability Scores and Energy Level</measure>
    <time_frame>Baseline 0 minutes, and 60, 120, 180 minutes postprandial</time_frame>
    <description>Assess change in subjective hunger, fullness, satiation, palatability and energy ratings using a visual analog scale ranging from 0-100 mm</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart Rate</measure>
    <time_frame>Baseline 0 minutes</time_frame>
    <description>Measure heart rate following the resting metabolic rate test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood Pressure</measure>
    <time_frame>Baseline 0 minutes</time_frame>
    <description>Measure blood pressure following the resting metabolic rate test</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">11</enrollment>
  <condition>Weight Loss</condition>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Whole Food Meal</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Whole foods meal - grilled cheese and drink meal</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Processed Food Meal</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Highly processed foods - grilled cheese and drink meal</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Gluten-Free and Lactose-Free Meal</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Gluten-free and lactose-free foods - grilled cheese and drink meal</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Whole Food Meal</intervention_name>
    <description>Whole foods meal</description>
    <arm_group_label>Whole Food Meal</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Processed Food Meal</intervention_name>
    <description>Processed food meal</description>
    <arm_group_label>Processed Food Meal</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Gluten-free and lactose-free</intervention_name>
    <description>Gluten-free and lactose-free food meal</description>
    <arm_group_label>Gluten-Free and Lactose-Free Meal</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy females between the ages of 18 and 24 years that have BMIs that fall in the&#xD;
             range of 18.5 kg/m2 to 28 kg/m2.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Those with a history of celiac disease or other food allergies, metabolic disease or&#xD;
             heart disease.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>24 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mary Hoehn, MPH</last_name>
    <role>Study Chair</role>
    <affiliation>Skidmore College</affiliation>
  </overall_official>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 11, 2020</study_first_submitted>
  <study_first_submitted_qc>June 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 22, 2020</study_first_posted>
  <last_update_submitted>June 17, 2020</last_update_submitted>
  <last_update_submitted_qc>June 17, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Weight Loss</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/NCT04440826
org study id: 1502-441
nct id: NCT04440826
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This study will investigate the acute effect of three isocaloric meals varying in level of
      food processing, including a whole foods, gluten-free, and highly processed meal on energy
      metabolism and blood glucose in 8-12 young adult, normal weight females. A secondary aim of
      this proposed study is to compare palatability, satiety, and perceived energy ratings among
      highly processed, unrefined, and gluten-free unrefined isocaloric meals.
A shift towards a diet containing large quantities of highly processed foods is believed to
      be a major contributor to the trends in obesity. The degree of processing of foods often
      affects the nutritional content of the constituents. A reduction in macromolecular complexity
      allows for an increased rate of digestion, meaning that the body does not have to work as
      hard to metabolize high processed food products. Thus, the purpose of this study is to
      investigate the effect on energy metabolism and blood glucose after the consumption of an
      unrefined, whole foods meal versus two highly processed food meals, including a common
      Western style meal and gluten-free meal in 8-12 young adult, normal weight females. A
      secondary aim of this proposed study is to compare palatability, satiety, and perceived
      energy ratings among highly processed, unrefined, and gluten-free unrefined isocaloric meals.
      It is hypothesized that an unrefined meal will induce a greater postprandial thermogenic
      response and a smaller blood glucose response than a highly processed or gluten-free meal.
      Additionally, it is hypothesized that a highly processed foods meal will be considered more
      palatable than an unrefined or gluten-free meal.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Thermic Effect of Meals (TEM) also known as Postprandial Thermogenesis
time frame: TEM; 45-60; 105-120; and 165-180 minutes after meal ingestion
description: The total amount of calories burned after each meal will be measured using indirect calorimetry with the ventilated hood technique. Specifically, the thermic effect of each meal will be measured for a total of three hours at 45 minute intervals for 15 minutes at a time (45-60; 105-120; and 165-180 minutes)
measure: Blood Glucose Response
time frame: Baseline line 0 minutes, and 60, 120, 180 minutes postprandial
description: Change in postprandial blood glucose compared baseline
measure: Change in Hunger and Palatability Scores and Energy Level
time frame: Baseline 0 minutes, and 60, 120, 180 minutes postprandial
description: Assess change in subjective hunger, fullness, satiation, palatability and energy ratings using a visual analog scale ranging from 0-100 mm
measure: Heart Rate
time frame: Baseline 0 minutes
description: Measure heart rate following the resting metabolic rate test
measure: Blood Pressure
time frame: Baseline 0 minutes
description: Measure blood pressure following the resting metabolic rate test
arm group label: Whole Food Meal
arm group type: Active Comparator
description: Whole foods meal - grilled cheese and drink meal
arm group label: Processed Food Meal
arm group type: Experimental
description: Highly processed foods - grilled cheese and drink meal
arm group label: Gluten-Free and Lactose-Free Meal
arm group type: Experimental
description: Gluten-free and lactose-free foods - grilled cheese and drink meal
intervention type: Other
intervention name: Whole Food Meal
description: Whole foods meal
arm group label: Whole Food Meal
intervention type: Other
intervention name: Processed Food Meal
description: Processed food meal
arm group label: Processed Food Meal
intervention type: Other
intervention name: Gluten-free and lactose-free
description: Gluten-free and lactose-free food meal
arm group label: Gluten-Free and Lactose-Free Meal
criteria: 
gender: Female
gender based: Yes
minimum age: 18 Years
maximum age: 24 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Mary Hoehn, MPH
role: Study Chair
affiliation: Skidmore College
responsible party type: Sponsor
mesh term: Weight Loss
sharing ipd: No