<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/NCT04437550</url>
  </required_header>
  <id_info>
    <org_study_id>801776</org_study_id>
    <nct_id>NCT04437550</nct_id>
  </id_info>
  <brief_title>Effects of Exercise Intensity on Energy Intake, Appetite and Enjoyment in Overweight and Obese Females</brief_title>
  <official_title>Effects of Exercise Intensity on Energy Intake, Appetite and Enjoyment in Overweight and Obese Females</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ohio University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Marywood University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Ohio University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Interval exercise involves short bouts of high intensity exercise interspersed with periods&#xD;
      of lower intensity exercise. The benefit is that a shorter total duration of exercise may be&#xD;
      required to achieve cardiovascular benefits similar to or even superior to traditional longer&#xD;
      bouts of steady state endurance exercise. However how this type of exercise affects appetite&#xD;
      and energy intake, particularly in overweight and obese females is not well known.&#xD;
&#xD;
      This study involves two trials of exercise, one at high intensity and one at low intensity,&#xD;
      followed by a buffet lunch, in overweight and obese females.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2016</start_date>
  <completion_date type="Actual">August 2016</completion_date>
  <primary_completion_date type="Actual">June 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>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in energy expenditure</measure>
    <time_frame>immediately pre-breakfast, immediately pre-exercise, during exercise, and immediately post-exercise.</time_frame>
    <description>caloric expenditure measured via indirect calorimetry</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in energy intake</measure>
    <time_frame>immediately post exercise</time_frame>
    <description>measured via standardized lunch</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in appetite</measure>
    <time_frame>immediately pre-breakfast, immediately post-breakfast, immediately post-exercise and immediately pre-lunch</time_frame>
    <description>measured via circulating hormones leptin and acylated ghrelin</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in subjective hunger</measure>
    <time_frame>baseline, immediately pre-exercise, immediately post-exercise, immediately pre-lunch, and immediately post-lunch</time_frame>
    <description>via visual analogue scale 100 mm, higher scores indicate greater hunger</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">11</enrollment>
  <condition>Overweight and Obesity</condition>
  <arm_group>
    <arm_group_label>high-intensity</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>low-intensity</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Exercise</intervention_name>
    <description>high intensity exercise = 15 x 60 s sprints at 85% velocity of VO2max (vVO2max) with 60 s walking at 20% vVO2max or moderate intensity exercise = walking at 60% vVO2max</description>
    <arm_group_label>high-intensity</arm_group_label>
    <arm_group_label>low-intensity</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Female&#xD;
&#xD;
          2. Adult&#xD;
&#xD;
          3. apparently healthy&#xD;
&#xD;
          4. overweight or class I obese&#xD;
&#xD;
          5. eumenorrheic&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Diabetes&#xD;
&#xD;
          2. pregnancy&#xD;
&#xD;
          3. cardiovascular disease&#xD;
&#xD;
          4. greater than 1 hour of structured physical activity per week&#xD;
&#xD;
          5. thyroid disease&#xD;
&#xD;
          6. polycystic ovary disease&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>female</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Human Physiology Lab</name>
      <address>
        <city>Scranton</city>
        <state>Pennsylvania</state>
        <zip>18509</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 15, 2020</study_first_submitted>
  <study_first_submitted_qc>June 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 18, 2020</study_first_posted>
  <last_update_submitted>June 16, 2020</last_update_submitted>
  <last_update_submitted_qc>June 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 18, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Marywood University</investigator_affiliation>
    <investigator_full_name>Angela Hillman</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>Overweight</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/NCT04437550
org study id: 801776
nct id: NCT04437550
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Interval exercise involves short bouts of high intensity exercise interspersed with periods
      of lower intensity exercise. The benefit is that a shorter total duration of exercise may be
      required to achieve cardiovascular benefits similar to or even superior to traditional longer
      bouts of steady state endurance exercise. However how this type of exercise affects appetite
      and energy intake, particularly in overweight and obese females is not well known.

      This study involves two trials of exercise, one at high intensity and one at low intensity,
      followed by a buffet lunch, in overweight and obese females.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Change in energy expenditure
time frame: immediately pre-breakfast, immediately pre-exercise, during exercise, and immediately post-exercise.
description: caloric expenditure measured via indirect calorimetry
measure: Change in energy intake
time frame: immediately post exercise
description: measured via standardized lunch
measure: Change in appetite
time frame: immediately pre-breakfast, immediately post-breakfast, immediately post-exercise and immediately pre-lunch
description: measured via circulating hormones leptin and acylated ghrelin
measure: Change in subjective hunger
time frame: baseline, immediately pre-exercise, immediately post-exercise, immediately pre-lunch, and immediately post-lunch
description: via visual analogue scale 100 mm, higher scores indicate greater hunger
arm group label: high-intensity
arm group type: Experimental
arm group label: low-intensity
arm group type: Experimental
intervention type: Other
intervention name: Exercise
description: high intensity exercise = 15 x 60 s sprints at 85% velocity of VO2max (vVO2max) with 60 s walking at 20% vVO2max or moderate intensity exercise = walking at 60% vVO2max
arm group label: high-intensity
arm group label: low-intensity
criteria: 
gender: Female
gender based: Yes
gender description: female
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Marywood University
investigator full name: Angela Hillman
investigator title: Assistant Professor
mesh term: Overweight
sharing ipd: No