xml: <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/NCT06017440</url>
    </required_header>
    <id_info>
      <org_study_id>RBHP 2023 BOIRIE 3</org_study_id>
      <secondary_id>2023-A00808-37</secondary_id>
      <nct_id>NCT06017440</nct_id>
    </id_info>
    <brief_title>Effect of Acute Exercise on Sensory and Hedonic Responses to a Fixed Meal in Adolescents With Obesity</brief_title>
    <acronym>SMASH</acronym>
    <official_title>Effect of Acute Exercise on Sensory and Hedonic Responses to a Fixed Meal in Adolescents With Obesity</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University Hospital, Clermont-Ferrand</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University Hospital, Clermont-Ferrand</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>
        While long considered independently, energy expenditure and energy intake have been shown to&#xD;
        interact. Fot the last 20 years, the litterature has been describing tyhe effects of an acute&#xD;
        bout of exercise on subsequent energy intake and appetitive responses, indicating a potenital&#xD;
        anorexigenic effect of intensive exercise in adolescents with obesity. These studies suggest&#xD;
        a decrease in hunger, redcued satiety and modified food reward responses.&#xD;
  &#xD;
        These results remain however obtained in studies using post exercise ad libitum test meals&#xD;
        and this nature of the meal might ahve impact these responses.&#xD;
  &#xD;
        The present work tends to assess the effect of acute exercise on subsequent appetite and food&#xD;
        reward responses to a fixed meal, in adolescents with obesity.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        After an inclusion visit to ensure the aptitude of adolescents to complete the entire study,&#xD;
        each will have to carry out densitometric measurements (body composition and bone structure).&#xD;
        The adolescents will then carry out, in a randomized manner, 2 experimental sessions spaced&#xD;
        at least 7 days apart: i) a control session (CON); ii) a session with a pedaling exercise at&#xD;
        65% of their estimated maximum capacity (EX).&#xD;
  &#xD;
        During each of these experimental sessions, teenagers will receive a calibrated breakfast at&#xD;
        08:00 am. During the CON session, teenagers should not perform any physical activity during&#xD;
        the day and they will be asked to stay at 11 a.m., for 30 minutes, resting in a semi-supine&#xD;
        position. During the EX session, teenagers will perform moderate-intensity physical exercise&#xD;
        (65% of their estimated maximum capacity) at 11 a.m. At noon, the teenagers will have to&#xD;
        consume a calibrated meal. Questionnaires on feelings of hunger will be distributed to them&#xD;
        at regular intervals. They will also be asked to complete a 10-minute computer exercise to&#xD;
        assess their relationship to food just before and just after the calibrated midday meal&#xD;
        (LFPQ. Leeds Food Preference Questionnaire, Liking/Wanting, French version). Sixty minutes&#xD;
        after the calibrated meal, teenagers will have an ad libitum buffet available for one hour.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">October 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">October 1, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>APPETITE FEELINGS</measure>
      <time_frame>immediately after lunch</time_frame>
      <description>appetite sensation will be assessed using visual analog scales</description>
    </primary_outcome>
    <primary_outcome>
      <measure>FOOD reward</measure>
      <time_frame>at lunch time</time_frame>
      <description>food reward will be assessed using the leeds food preference questionnaire</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Energy intake</measure>
      <time_frame>at lunch time</time_frame>
      <description>energy intake will be assessed ad libitum at the following diner</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">16</enrollment>
    <condition>CONTROL Condition</condition>
    <condition>Exercise</condition>
    <arm_group>
      <arm_group_label>adolescents with obesity</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>There is only one arm as this is an acute randomized study comparing two differents conditions within the same sample of participants.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>EXERCISE</intervention_name>
      <description>Participants will receive at 08:00 am a calibrated breakfast of 500kcal. They should not perform physical exercise during the day. They will be asked at 11 a.m. to cycle for 30 minutes at 65% of the maximal capacities and their energy expenditure will be measured by indirect calorimetry. At 11 a.m., teenagers will receive a calibrated meal of 800 kcal respecting the nutritional recommendations for this age. Questionnaires on feelings of hunger will be distributed to them at regular intervals. They will also be asked to complete a 10-minute computer exercise to assess their relationship to food before and after lunch (LFPQ. Leeds Food Preference Questionnaire, Liking/ wanting). Finally, from 60 minutes after the midday test meal, teenagers will have access to an ad libitum buffet for one hour.</description>
      <arm_group_label>adolescents with obesity</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>CONTROL</intervention_name>
      <description>Teenagers should not perform any physical activity during the day and they will be asked to stay at 11 a.m., for 30 minutes, resting in a semi-supine position.</description>
      <arm_group_label>adolescents with obesity</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Subjects aged 11 to 16 years (inclusive limits), maturation stage 3-5 according to the&#xD;
               Tanner classification, with obesity defined by a body mass index (BMI) greater than&#xD;
               the 97th percentile according to national curves (Roland- Cachera et al., 1991).&#xD;
  &#xD;
            -  Adolescent who has signed the information and consent form and whose holders of&#xD;
               parental authority have signed the information and consent form&#xD;
  &#xD;
            -  Person subject to a Social Security scheme&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Medical or surgical history deemed by the investigator to be incompatible with the study&#xD;
  &#xD;
            -  Presence of diabetes, and any other pathology limiting the application of one or the&#xD;
               other strategy to the trial.&#xD;
  &#xD;
            -  Taking medications that may interfere with the results of the study&#xD;
  &#xD;
            -  Subjects with cardiovascular problems, here we are talking about subjects with a&#xD;
               history of cardiovascular and/or neurovascular pathology, as well as subjects&#xD;
               presenting cardiovascular and/or neurovascular risk factors (excluding obesity/&#xD;
               overweight).&#xD;
  &#xD;
            -  Surgical intervention in the previous 3 months.&#xD;
  &#xD;
            -  Subjects undergoing energy restriction or weight loss program through physical&#xD;
               activity at the time of inclusion or during the last six months.&#xD;
  &#xD;
            -  Consumption of tobacco or alcohol.&#xD;
  &#xD;
            -  Special diet.&#xD;
  &#xD;
            -  Participation in regular and intense physical and sports activities for more than two&#xD;
               hours per week.&#xD;
  &#xD;
            -  Teenagers whose parents are under guardianship, curatorship, safeguard of justice or&#xD;
               not subject to a social security system&#xD;
  &#xD;
            -  Refusal to sign the information and consent notice&#xD;
  &#xD;
            -  Person in period of exclusion from another study&#xD;
  &#xD;
            -  Pregnant or breastfeeding adolescents on declarative&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>11 Years</minimum_age>
      <maximum_age>16 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Yves Boirie</last_name>
      <role>Principal Investigator</role>
      <affiliation>University Hospital, Clermont-Ferrand</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Lise LACLAUTRE</last_name>
      <phone>+33473754963</phone>
      <email>promo_interne_drci@chu-clermontferrand.fr</email>
    </overall_contact>
    <verification_date>June 2023</verification_date>
    <study_first_submitted>June 13, 2023</study_first_submitted>
    <study_first_submitted_qc>August 29, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 30, 2023</study_first_posted>
    <last_update_submitted>August 29, 2023</last_update_submitted>
    <last_update_submitted_qc>August 29, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 30, 2023</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>Obesity</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06017440
  org study id: RBHP 2023 BOIRIE 3
  secondary id: 2023-A00808-37
  nct id: NCT06017440
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  While long considered independently, energy expenditure and energy intake have been shown to
        interact. Fot the last 20 years, the litterature has been describing tyhe effects of an acute
        bout of exercise on subsequent energy intake and appetitive responses, indicating a potenital
        anorexigenic effect of intensive exercise in adolescents with obesity. These studies suggest
        a decrease in hunger, redcued satiety and modified food reward responses.
  
        These results remain however obtained in studies using post exercise ad libitum test meals
        and this nature of the meal might ahve impact these responses.
  
        The present work tends to assess the effect of acute exercise on subsequent appetite and food
        reward responses to a fixed meal, in adolescents with obesity.
  After an inclusion visit to ensure the aptitude of adolescents to complete the entire study,
        each will have to carry out densitometric measurements (body composition and bone structure).
        The adolescents will then carry out, in a randomized manner, 2 experimental sessions spaced
        at least 7 days apart: i) a control session (CON); ii) a session with a pedaling exercise at
        65% of their estimated maximum capacity (EX).
  
        During each of these experimental sessions, teenagers will receive a calibrated breakfast at
        08:00 am. During the CON session, teenagers should not perform any physical activity during
        the day and they will be asked to stay at 11 a.m., for 30 minutes, resting in a semi-supine
        position. During the EX session, teenagers will perform moderate-intensity physical exercise
        (65% of their estimated maximum capacity) at 11 a.m. At noon, the teenagers will have to
        consume a calibrated meal. Questionnaires on feelings of hunger will be distributed to them
        at regular intervals. They will also be asked to complete a 10-minute computer exercise to
        assess their relationship to food just before and just after the calibrated midday meal
        (LFPQ. Leeds Food Preference Questionnaire, Liking/Wanting, French version). Sixty minutes
        after the calibrated meal, teenagers will have an ad libitum buffet available for one hour.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Prevention
  masking: None (Open Label)
  measure: APPETITE FEELINGS
  time frame: immediately after lunch
  description: appetite sensation will be assessed using visual analog scales
  measure: FOOD reward
  time frame: at lunch time
  description: food reward will be assessed using the leeds food preference questionnaire
  measure: Energy intake
  time frame: at lunch time
  description: energy intake will be assessed ad libitum at the following diner
  arm group label: adolescents with obesity
  arm group type: Experimental
  description: There is only one arm as this is an acute randomized study comparing two differents conditions within the same sample of participants.
  intervention type: Behavioral
  intervention name: EXERCISE
  description: Participants will receive at 08:00 am a calibrated breakfast of 500kcal. They should not perform physical exercise during the day. They will be asked at 11 a.m. to cycle for 30 minutes at 65% of the maximal capacities and their energy expenditure will be measured by indirect calorimetry. At 11 a.m., teenagers will receive a calibrated meal of 800 kcal respecting the nutritional recommendations for this age. Questionnaires on feelings of hunger will be distributed to them at regular intervals. They will also be asked to complete a 10-minute computer exercise to assess their relationship to food before and after lunch (LFPQ. Leeds Food Preference Questionnaire, Liking/ wanting). Finally, from 60 minutes after the midday test meal, teenagers will have access to an ad libitum buffet for one hour.
  arm group label: adolescents with obesity
  intervention type: Behavioral
  intervention name: CONTROL
  description: Teenagers should not perform any physical activity during the day and they will be asked to stay at 11 a.m., for 30 minutes, resting in a semi-supine position.
  arm group label: adolescents with obesity
  criteria: 
  gender: All
  minimum age: 11 Years
  maximum age: 16 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Yves Boirie
  role: Principal Investigator
  affiliation: University Hospital, Clermont-Ferrand
  last name: Lise LACLAUTRE
  phone: +33473754963
  email: promo_interne_drci@chu-clermontferrand.fr
  responsible party type: Sponsor
  mesh term: Obesity