<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/NCT04483921</url>
  </required_header>
  <id_info>
    <org_study_id>PBRC 2020-003</org_study_id>
    <nct_id>NCT04483921</nct_id>
  </id_info>
  <brief_title>SubsTRate OxidatioN in Girls</brief_title>
  <acronym>STRONG</acronym>
  <official_title>Race Differences in 24-hour Energy Expenditure, Substrate Oxidation, and Appetite in Adolescent Girls</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pennington Biomedical Research Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Nutrition Obesity Research Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Pennington Biomedical Research Center</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>
      This study will examine race differences in total energy expenditure and respiratory quotient&#xD;
      (RQ) during and after exercise, compared to a sedentary control condition, in adolescent&#xD;
      girls who are classified as overweight. In addition, subjective appetite and objective energy&#xD;
      intake will be measured throughout the assessment periods.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Aim 1: Measure 24-hour energy expenditure and its components (resting, activity, and sleep&#xD;
      energy expenditure) and compare differences between African-American and White girls.&#xD;
&#xD;
      Hypothesis: Total, resting, and sleep energy expenditure will be lower in African-American&#xD;
      relative to White girls. Activity energy expenditure will be equivalent per the study design.&#xD;
&#xD;
      Aim 2: Measure and compare substrate oxidation and associations with appetite (i.e., hunger,&#xD;
      desire to eat) and energy intake between African-American and White girls.&#xD;
&#xD;
      Hypothesis: African-American girls will have a higher RQ at rest, during exercise, and&#xD;
      following exercise, and RQ will be positively associated with subjective appetite ratings and&#xD;
      energy intake.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 15, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</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>
    <intervention_model_description>Within-subjects crossover design. The order of conditions is counterbalanced within each subgroup of participants.</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Exercise Day Energy expenditure</measure>
    <time_frame>24 hours on Exercise Day</time_frame>
    <description>Total energy expenditure and its components (sleeping, wake [non-exercise], activity) as measured by the metabolic chamber</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Sedentary Day Energy expenditure</measure>
    <time_frame>24 hours on Sedentary Day</time_frame>
    <description>Total energy expenditure and its components (sleeping, wake [non-exercise], activity) as measured by the metabolic chamber</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Exercise Day Substrate oxidation</measure>
    <time_frame>24 hours on Exercise Day</time_frame>
    <description>Non-protein respiratory quotient (i.e., carbohydrate and fat utilization) as measured by the metabolic chamber</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Sedentary Day Substrate oxidation</measure>
    <time_frame>24 hours on Sedentary Day</time_frame>
    <description>Non-protein respiratory quotient (i.e., carbohydrate and fat utilization) as measured by the metabolic chamber</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Exercise Day Appetite</measure>
    <time_frame>24 hours on Exercise Day</time_frame>
    <description>Overall subjective appetite and its components (hunger, fullness, desire to eat, prospective food consumption, satisfaction, food wanting) assessed by visual analog scales (0-100 mm) during the metabolic chamber assessments</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sedentary Day Appetite</measure>
    <time_frame>24 hours on Sedentary Day</time_frame>
    <description>Overall subjective appetite and its components (hunger, fullness, desire to eat, prospective food consumption, satisfaction, food wanting) assessed by visual analog scales (0-100 mm) during the metabolic chamber assessments</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Exercise Day Energy Intake</measure>
    <time_frame>24 hours on Exercise Day</time_frame>
    <description>Objectively measured food intake during the metabolic chamber assessments will be converted to energy intake in kilocalories</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sedentary Day Energy Intake</measure>
    <time_frame>24 hours on Sedentary Day</time_frame>
    <description>Objectively measured food intake during the metabolic chamber assessments will be converted to energy intake in kilocalories</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Dual-energy x-ray absorptiometry (DXA)</measure>
    <time_frame>Baseline screening visit</time_frame>
    <description>Total body composition (fat, muscle, bone tissue) measured by Hologic Discovery DXA</description>
  </other_outcome>
  <other_outcome>
    <measure>Body shape</measure>
    <time_frame>Baseline screening visit</time_frame>
    <description>3D optical imaging assessment of body shape by Fit3D scanner</description>
  </other_outcome>
  <other_outcome>
    <measure>Cardiorespiratory fitness</measure>
    <time_frame>Baseline screening visit</time_frame>
    <description>Maximal aerobic capacity assessed by graded cycle ergometer test to volitional fatigue</description>
  </other_outcome>
  <other_outcome>
    <measure>Resting metabolic rate</measure>
    <time_frame>Baseline screening visit</time_frame>
    <description>Measured over a 30-minute period by ventilated hood and metabolic cart</description>
  </other_outcome>
  <other_outcome>
    <measure>Implicit activity preferences</measure>
    <time_frame>Baseline screening visit</time_frame>
    <description>Relative preference for physical versus sedentary activities as assessed by a forced-choice behavioral task</description>
  </other_outcome>
  <other_outcome>
    <measure>Habitual physical activity</measure>
    <time_frame>7 days leading up to Exercise Day and Sedentary Day</time_frame>
    <description>Accelerometry measures of usual physical activity before each experimental visit</description>
  </other_outcome>
  <other_outcome>
    <measure>Habitual sedentary time</measure>
    <time_frame>7 days leading up to Exercise Day and Sedentary Day</time_frame>
    <description>Accelerometry measures of usual sedentary time before each experimental visit</description>
  </other_outcome>
  <other_outcome>
    <measure>Habitual food intake</measure>
    <time_frame>3 days leading up to Exercise Day and Sedentary Day</time_frame>
    <description>Food intake diary/dietary record to assist participants in maintaining consistent diet before each experimental visit</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Overweight Adolescents</condition>
  <arm_group>
    <arm_group_label>Exercise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will complete a prescribed exercise bout.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sedentary</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants will rest quietly in a seated position for the equivalent amount of time prescribed for the exercise condition.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Acute exercise</intervention_name>
    <description>Participants will complete a morning exercise bout at 70% of their individual maximal aerobic capacity to burn 200 kilocalories above their basal metabolic rate.</description>
    <arm_group_label>Exercise</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female&#xD;
&#xD;
          -  Age 13-17 years, inclusive&#xD;
&#xD;
          -  Achieved menarche based on parent- and/or self-report&#xD;
&#xD;
          -  Overweight based on BMI percentile for age and sex (≥ 85th and &lt; 95th)&#xD;
&#xD;
          -  Self-identification as non-Hispanic White or African-American&#xD;
&#xD;
          -  Willing to maintain current physical activity, sleep schedule, and dietary habits&#xD;
             during the study&#xD;
&#xD;
          -  Willing to comply with study procedures&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Contraindications to exercise testing as defined by the American College of Sports&#xD;
             Medicine (i.e., medical history of cardiovascular, pulmonary, or physical conditions&#xD;
             that affect the ability to exercise)&#xD;
&#xD;
          -  Food allergies&#xD;
&#xD;
          -  Dietary restrictions&#xD;
&#xD;
          -  Unwilling to consume study foods&#xD;
&#xD;
          -  History of polycystic ovary syndrome (PCOS)&#xD;
&#xD;
          -  Current amenorrhea or other menstrual cycle irregularities&#xD;
&#xD;
          -  Pregnant or currently breastfeeding&#xD;
&#xD;
          -  Current anemia&#xD;
&#xD;
          -  Use of medications affecting metabolism or sleep&#xD;
&#xD;
          -  Inability to properly or safely complete the study procedures per the investigators'&#xD;
             discretion&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>13 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Eric Ravussin, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Professor</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Eric Ravussin, PhD</last_name>
    <phone>2257633186</phone>
    <email>eric.ravussin@pbrc.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Nicole Fearnbach, PhD</last_name>
    <phone>2257632612</phone>
    <email>nicole.fearnbach@pbrc.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Pennington Biomedical Research Center</name>
      <address>
        <city>Baton Rouge</city>
        <state>Louisiana</state>
        <zip>70808</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Eric Ravussin, PhD</last_name>
      <phone>225-763-3186</phone>
      <email>eric.ravussin@pbrc.edu</email>
    </contact>
    <contact_backup>
      <last_name>Nicole Fearnbach, PhD</last_name>
      <phone>2257632612</phone>
      <email>nicole.fearnbach@pbrc.edu</email>
    </contact_backup>
    <investigator>
      <last_name>Nicole Fearnbach, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Leanne Redman, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Peter Katzmarzyk, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Daniel Hsia, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Neil Johannsen, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Heather Allaway, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Eric Ravussin, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>July 14, 2020</study_first_submitted>
  <study_first_submitted_qc>July 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 23, 2020</study_first_posted>
  <last_update_submitted>May 5, 2023</last_update_submitted>
  <last_update_submitted_qc>May 5, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 8, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Pennington Biomedical Research Center</investigator_affiliation>
    <investigator_full_name>Eric Ravussin</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Energy expenditure</keyword>
  <keyword>Substrate oxidation</keyword>
  <keyword>Appetite</keyword>
  <keyword>Exercise</keyword>
  <keyword>Energy intake</keyword>
  <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>
    <ipd_description>De-identified IPD will be housed indefinitely on secure digital servers as part of the Pennington Biomedical Clinical Database. De-identified IPD may be made available to other researchers upon reasonable request to the Principal Investigator, following Pennington Biomedical's standard procedures for data use agreements and secure data transfers.</ipd_description>
  </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/NCT04483921
org study id: PBRC 2020-003
nct id: NCT04483921
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study will examine race differences in total energy expenditure and respiratory quotient
      (RQ) during and after exercise, compared to a sedentary control condition, in adolescent
      girls who are classified as overweight. In addition, subjective appetite and objective energy
      intake will be measured throughout the assessment periods.
Aim 1: Measure 24-hour energy expenditure and its components (resting, activity, and sleep
      energy expenditure) and compare differences between African-American and White girls.

      Hypothesis: Total, resting, and sleep energy expenditure will be lower in African-American
      relative to White girls. Activity energy expenditure will be equivalent per the study design.

      Aim 2: Measure and compare substrate oxidation and associations with appetite (i.e., hunger,
      desire to eat) and energy intake between African-American and White girls.

      Hypothesis: African-American girls will have a higher RQ at rest, during exercise, and
      following exercise, and RQ will be positively associated with subjective appetite ratings and
      energy intake.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: Within-subjects crossover design. The order of conditions is counterbalanced within each subgroup of participants.
primary purpose: Basic Science
masking: None (Open Label)
measure: Exercise Day Energy expenditure
time frame: 24 hours on Exercise Day
description: Total energy expenditure and its components (sleeping, wake [non-exercise], activity) as measured by the metabolic chamber
measure: Sedentary Day Energy expenditure
time frame: 24 hours on Sedentary Day
description: Total energy expenditure and its components (sleeping, wake [non-exercise], activity) as measured by the metabolic chamber
measure: Exercise Day Substrate oxidation
time frame: 24 hours on Exercise Day
description: Non-protein respiratory quotient (i.e., carbohydrate and fat utilization) as measured by the metabolic chamber
measure: Sedentary Day Substrate oxidation
time frame: 24 hours on Sedentary Day
description: Non-protein respiratory quotient (i.e., carbohydrate and fat utilization) as measured by the metabolic chamber
measure: Exercise Day Appetite
time frame: 24 hours on Exercise Day
description: Overall subjective appetite and its components (hunger, fullness, desire to eat, prospective food consumption, satisfaction, food wanting) assessed by visual analog scales (0-100 mm) during the metabolic chamber assessments
measure: Sedentary Day Appetite
time frame: 24 hours on Sedentary Day
description: Overall subjective appetite and its components (hunger, fullness, desire to eat, prospective food consumption, satisfaction, food wanting) assessed by visual analog scales (0-100 mm) during the metabolic chamber assessments
measure: Exercise Day Energy Intake
time frame: 24 hours on Exercise Day
description: Objectively measured food intake during the metabolic chamber assessments will be converted to energy intake in kilocalories
measure: Sedentary Day Energy Intake
time frame: 24 hours on Sedentary Day
description: Objectively measured food intake during the metabolic chamber assessments will be converted to energy intake in kilocalories
measure: Dual-energy x-ray absorptiometry (DXA)
time frame: Baseline screening visit
description: Total body composition (fat, muscle, bone tissue) measured by Hologic Discovery DXA
measure: Body shape
time frame: Baseline screening visit
description: 3D optical imaging assessment of body shape by Fit3D scanner
measure: Cardiorespiratory fitness
time frame: Baseline screening visit
description: Maximal aerobic capacity assessed by graded cycle ergometer test to volitional fatigue
measure: Resting metabolic rate
time frame: Baseline screening visit
description: Measured over a 30-minute period by ventilated hood and metabolic cart
measure: Implicit activity preferences
time frame: Baseline screening visit
description: Relative preference for physical versus sedentary activities as assessed by a forced-choice behavioral task
measure: Habitual physical activity
time frame: 7 days leading up to Exercise Day and Sedentary Day
description: Accelerometry measures of usual physical activity before each experimental visit
measure: Habitual sedentary time
time frame: 7 days leading up to Exercise Day and Sedentary Day
description: Accelerometry measures of usual sedentary time before each experimental visit
measure: Habitual food intake
time frame: 3 days leading up to Exercise Day and Sedentary Day
description: Food intake diary/dietary record to assist participants in maintaining consistent diet before each experimental visit
arm group label: Exercise
arm group type: Experimental
description: Participants will complete a prescribed exercise bout.
arm group label: Sedentary
arm group type: No Intervention
description: Participants will rest quietly in a seated position for the equivalent amount of time prescribed for the exercise condition.
intervention type: Other
intervention name: Acute exercise
description: Participants will complete a morning exercise bout at 70% of their individual maximal aerobic capacity to burn 200 kilocalories above their basal metabolic rate.
arm group label: Exercise
criteria: 
gender: Female
minimum age: 13 Years
maximum age: 17 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Eric Ravussin, PhD
role: Principal Investigator
affiliation: Professor
last name: Eric Ravussin, PhD
phone: 2257633186
email: eric.ravussin@pbrc.edu
last name: Nicole Fearnbach, PhD
phone: 2257632612
email: nicole.fearnbach@pbrc.edu
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Pennington Biomedical Research Center
investigator full name: Eric Ravussin
investigator title: Professor
mesh term: Overweight
sharing ipd: No
ipd description: De-identified IPD will be housed indefinitely on secure digital servers as part of the Pennington Biomedical Clinical Database. De-identified IPD may be made available to other researchers upon reasonable request to the Principal Investigator, following Pennington Biomedical's standard procedures for data use agreements and secure data transfers.