<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/NCT03807609</url>
  </required_header>
  <id_info>
    <org_study_id>CHU-419</org_study_id>
    <nct_id>NCT03807609</nct_id>
  </id_info>
  <brief_title>Energy Intake and Exercise Timing</brief_title>
  <official_title>Does Exercise Timing Modify Post-exercise Energy Intake in Adolescents With Obesity</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Clermont-Ferrand</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Tza Nou - Maison médicale pour enfants et adolescentes - 230, rue Vercingétorix - B.P. 77 - 63150 La Bourboule</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>SSR Nutrition-Obésité - 33-35 rue Maréchal Leclerc - 63000 Clermont-Ferrand</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Université d'Auvergne</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Clermont-Ferrand</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>
      The aim of the present study is to compare the effect of an exercise performed 180 or 30&#xD;
      minutes before lunch on the energy intake of adolescents with obesity.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The present study will compare the nutritional response to the realisation of an acute&#xD;
      exercise 180 or 30 minutes before an ad libitum buffet meal in adolescents with obesity. 18&#xD;
      adolescents with obesity will be asked to randomly complete three experimental sessions: i)&#xD;
      one control session (rest); ii) one session with an acute exercise realized 180 minutes&#xD;
      before lunch; iii) one session with the same exercise performed 30 minutes before lunch.&#xD;
      Their ad libitum energy intake will be assessed during lunch as well as at dinner time.&#xD;
      Appetite feelings will be assessed at regular intervals and their food reward in response to&#xD;
      the lunch will also be assessed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 19, 2019</start_date>
  <completion_date type="Actual">March 31, 2019</completion_date>
  <primary_completion_date type="Actual">March 31, 2019</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>No masking</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Energy intake measured during an ad libitum buffet meal (in kcal).</measure>
    <time_frame>at day 1</time_frame>
    <description>food intake will be measured ad libitum during a lunch buffet. The adolescents will be offered an ad libitum buffet-type meal composed based on their food intake preferences. Their intake will be weighted using an electronic food scale (Casio Scale, units: grams) by a member of the investigation team and then analysed using Bilnuts software.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hunger feelings</measure>
    <time_frame>at day 1</time_frame>
    <description>hunger area under the curve will be assessed using visual analogue scale (VAS) through a the day ranging from 0 to 150, 0 being &quot;not at all&quot;, 150 being &quot;completely&quot;. The question asked being: How hungry are you right now?&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Food reward</measure>
    <time_frame>at day 1</time_frame>
    <description>Leeds Food Preference Questionnaire; LFPQ.Briefly, the LFPQ provides measures of the wanting and liking for an array of food images, varying in both fat content and taste.To measure the explicit liking and explicit wanting, participants are asked to rate the extent to which they &quot;liked&quot; or &quot;wanted&quot; each randomly presented food item with a 100-mm visual analogue scale. . The construct from the scales are : Explicit liking; Explicit Wanting; Implicit liking, implicit wanting, Fat Choice and Fat Taste. Each component ranged from -50 to +50. There is no total score.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>Pediatric Obesity</condition>
  <arm_group>
    <arm_group_label>CON .</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The adolescents will be asked to remain quiet and at rest during the morning and will receive an ad libitum meal at lunch and dinner times. Their food reward will be assessed before and after lunch. Their appetite feelings will be assessed at regular intervals.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>EX -30.</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The adolescents will be asked to complete a 30 minutes exercise set at 65% of their capacities (cycling), 30 minutes before lunch. Lunch will be served ad libitum as well as diner. Their food reward will be assessed before and after lunch. Their appetite feelings will be assessed at regular intervals.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>EX-180</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The adolescents will be asked to complete a 30 minutes exercise set at 65% of their capacities (cycling), 30 minutes before lunch. Lunch will be served ad libitum as well as diner. Their appetite feelings will be assessed at regular intervals.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>CON . control condition without exercise / rest condition</intervention_name>
    <description>Control condition without exercise / rest condition. The adolescents will be asked to remain quiet and at rest during the morning and will receive an ad libitum meal at lunch and dinner times. Their food reward will be assessed before and after lunch. Their appetite feelings will be assessed at regular intervals.</description>
    <arm_group_label>CON .</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>EX -30. Condition with an acute exercise set 30 minutes before lunch</intervention_name>
    <description>The adolescents will be asked to complete a 30 minutes exercise set at 65% of their capacities (cycling), 30 minutes before lunch. Lunch will be served ad libitum as well as diner. Their food reward will be assessed before and after lunch. Their appetite feelings will be assessed at regular intervals.</description>
    <arm_group_label>EX -30.</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>EX-180. condition with an acute exercise set 180 minutes before lunch</intervention_name>
    <description>The adolescents will be asked to complete a 30 minutes exercise set at 65% of their capacities (cycling), 30 minutes before lunch. Lunch will be served ad libitum as well as diner. Their food reward will be assessed before and after lunch. Their appetite feelings will be assessed at regular intervals.</description>
    <arm_group_label>EX-180</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  - BMI percentile &gt; 97th percentile according to the french curves.&#xD;
&#xD;
          -  ages 12-16 years old&#xD;
&#xD;
          -  Signed consent form&#xD;
&#xD;
          -  being registered in the national social security system&#xD;
&#xD;
          -  no contraindication to physical activity&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous surgical interventions that is considered as non-compatible with the study.&#xD;
&#xD;
          -  Diabetes&#xD;
&#xD;
          -  weight loss during the last 6 months&#xD;
&#xD;
          -  cardiovascular disease or risks&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>16 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Martine DUCLOS</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Clermont-Ferrand</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Chu Clermont-Ferrand</name>
      <address>
        <city>Clermont-Ferrand</city>
        <zip>63003</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>January 15, 2019</study_first_submitted>
  <study_first_submitted_qc>January 16, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 17, 2019</study_first_posted>
  <last_update_submitted>September 11, 2019</last_update_submitted>
  <last_update_submitted_qc>September 11, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 13, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>appetite control</keyword>
  <keyword>obesity</keyword>
  <keyword>Adolescents</keyword>
  <keyword>exercise timing</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</mesh_term>
    <mesh_term>Pediatric Obesity</mesh_term>
  </condition_browse>
  <!-- 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/NCT03807609
org study id: CHU-419
nct id: NCT03807609
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
The aim of the present study is to compare the effect of an exercise performed 180 or 30
      minutes before lunch on the energy intake of adolescents with obesity.
The present study will compare the nutritional response to the realisation of an acute
      exercise 180 or 30 minutes before an ad libitum buffet meal in adolescents with obesity. 18
      adolescents with obesity will be asked to randomly complete three experimental sessions: i)
      one control session (rest); ii) one session with an acute exercise realized 180 minutes
      before lunch; iii) one session with the same exercise performed 30 minutes before lunch.
      Their ad libitum energy intake will be assessed during lunch as well as at dinner time.
      Appetite feelings will be assessed at regular intervals and their food reward in response to
      the lunch will also be assessed.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Other
masking: None (Open Label)
masking description: No masking
measure: Energy intake measured during an ad libitum buffet meal (in kcal).
time frame: at day 1
description: food intake will be measured ad libitum during a lunch buffet. The adolescents will be offered an ad libitum buffet-type meal composed based on their food intake preferences. Their intake will be weighted using an electronic food scale (Casio Scale, units: grams) by a member of the investigation team and then analysed using Bilnuts software.
measure: Hunger feelings
time frame: at day 1
description: hunger area under the curve will be assessed using visual analogue scale (VAS) through a the day ranging from 0 to 150, 0 being "not at all", 150 being "completely". The question asked being: How hungry are you right now?"
measure: Food reward
time frame: at day 1
description: Leeds Food Preference Questionnaire; LFPQ.Briefly, the LFPQ provides measures of the wanting and liking for an array of food images, varying in both fat content and taste.To measure the explicit liking and explicit wanting, participants are asked to rate the extent to which they "liked" or "wanted" each randomly presented food item with a 100-mm visual analogue scale. . The construct from the scales are : Explicit liking; Explicit Wanting; Implicit liking, implicit wanting, Fat Choice and Fat Taste. Each component ranged from -50 to +50. There is no total score.
arm group label: CON .
arm group type: Experimental
description: The adolescents will be asked to remain quiet and at rest during the morning and will receive an ad libitum meal at lunch and dinner times. Their food reward will be assessed before and after lunch. Their appetite feelings will be assessed at regular intervals.
arm group label: EX -30.
arm group type: Experimental
description: The adolescents will be asked to complete a 30 minutes exercise set at 65% of their capacities (cycling), 30 minutes before lunch. Lunch will be served ad libitum as well as diner. Their food reward will be assessed before and after lunch. Their appetite feelings will be assessed at regular intervals.
arm group label: EX-180
arm group type: Experimental
description: The adolescents will be asked to complete a 30 minutes exercise set at 65% of their capacities (cycling), 30 minutes before lunch. Lunch will be served ad libitum as well as diner. Their appetite feelings will be assessed at regular intervals.
intervention type: Other
intervention name: CON . control condition without exercise / rest condition
description: Control condition without exercise / rest condition. The adolescents will be asked to remain quiet and at rest during the morning and will receive an ad libitum meal at lunch and dinner times. Their food reward will be assessed before and after lunch. Their appetite feelings will be assessed at regular intervals.
arm group label: CON .
intervention type: Other
intervention name: EX -30. Condition with an acute exercise set 30 minutes before lunch
description: The adolescents will be asked to complete a 30 minutes exercise set at 65% of their capacities (cycling), 30 minutes before lunch. Lunch will be served ad libitum as well as diner. Their food reward will be assessed before and after lunch. Their appetite feelings will be assessed at regular intervals.
arm group label: EX -30.
intervention type: Other
intervention name: EX-180. condition with an acute exercise set 180 minutes before lunch
description: The adolescents will be asked to complete a 30 minutes exercise set at 65% of their capacities (cycling), 30 minutes before lunch. Lunch will be served ad libitum as well as diner. Their food reward will be assessed before and after lunch. Their appetite feelings will be assessed at regular intervals.
arm group label: EX-180
criteria: 
gender: All
minimum age: 12 Years
maximum age: 16 Years
healthy volunteers: No
last name: Martine DUCLOS
role: Principal Investigator
affiliation: University Hospital, Clermont-Ferrand
facility: 
country: France
responsible party type: Sponsor
mesh term: Obesity
mesh term: Pediatric Obesity