<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/NCT03762629</url>
  </required_header>
  <id_info>
    <org_study_id>Trial2017.1</org_study_id>
    <nct_id>NCT03762629</nct_id>
  </id_info>
  <brief_title>Exercise and Diet Restriction on Cardiovascular Function in Obese Children and Adolescents</brief_title>
  <official_title>Effects of Exercise Training and Diet Restriction on Cardiovascular Function and Their Related Factors in Obese Chinese Children and Adolescents: an Intervention Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Guangzhou Sport University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Guangzhou Sport University</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>
      Prevalence rates of childhood obesity have reached alarming levels. As childhood obesity may&#xD;
      already be associated with serious comorbidities, obese adolescents are at significantly&#xD;
      higher risk for obesity and increased morbidity and mortality during adulthood. Combined&#xD;
      lifestyle interventions, which include regular physical activity and dietary restriction,&#xD;
      have been shown to result in most significant improvements in cardiovascular function and&#xD;
      their associated factors in the pediatric and adolescent population with obesity. The aim of&#xD;
      this study is to investigate the effects of a combined exercise and diet intervention on&#xD;
      cardiovascular function and their associated factors in obese children.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Sixty obese children and adolescents will complete a 6-week program of exercise and diet&#xD;
      intervention. Thirty normal-weight children and adolescents will be recruited as control&#xD;
      group. Clinical characteristics, body composition, blood biochemistry, and circulating irisin&#xD;
      levels of the subjects will be measured before and after 6-week intervention. Endothelial&#xD;
      function will be assessed by a flow-mediated dilation test. Circulating exosome-derived&#xD;
      miRNAs, exercise-induced epigenetic modifications, circulating irisin levels irisin&#xD;
      concentration in plasma and arterial stiffness as well as cardiac autonomic function will be&#xD;
      investigated before and after the 6-week intervention. Fecal samples were collected before&#xD;
      and after the 6-week intervention for analysis of the compositional and functional changes in&#xD;
      the human gut microbiota.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 1, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2018</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from flow-mediated dilation (FMD) at 6 weeks</measure>
    <time_frame>before and after the 6-week intervention</time_frame>
    <description>for brachial endothelial function assessment</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from circulating exosome-derived miRNAs at 6 weeks</measure>
    <time_frame>before and after the 6-week intervention</time_frame>
    <description>exosome-secreted miRNA levels in plasma</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from circulating irisin levels at 6 weeks</measure>
    <time_frame>before and after the 6-week intervention</time_frame>
    <description>irisin concentration in plasma</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from pulse wave velocity at 6 weeks</measure>
    <time_frame>before and after the 6-week intervention</time_frame>
    <description>for arterial stiffness assessment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from heart rate variability at 6 weeks</measure>
    <time_frame>before and after the 6-week intervention</time_frame>
    <description>for cardiac autonomic function assessment</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change from the composition of gut microbiota at 6 weeks</measure>
    <time_frame>before and after the 6-week intervention</time_frame>
    <description>the composition of gut microbiota in fecal samples</description>
  </other_outcome>
  <other_outcome>
    <measure>Change from short chain fatty acids (SCFAs) concentractions at 6 weeks</measure>
    <time_frame>before and after the 6-week intervention</time_frame>
    <description>short chain fatty acids (SCFAs) concentractions in fecal samples</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">90</enrollment>
  <condition>Childhood Obesity</condition>
  <condition>Adolescent Obesity</condition>
  <arm_group>
    <arm_group_label>Obese intervention group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Obese children were received exercise and diet intervention for 6 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Normal weight control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Normal weight children were recruited as a control group without any intervention.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Exercise</intervention_name>
    <description>Subjects were provided with energy-restricted diets of 1300-2200 kcal/day based on weight. The energy percentages provided by protein, fat and carbohydrate were 20%, 20% and 60%, respectively, while energy distributions at breakfast, lunch and dinner were 30%, 40% and 30%, respectively. Subjects performed a series of endurance exercise such as bicycling, walking, running, dancing and ball games for 5 hour/day, supplemented with resistance exercise. Training interventions were performed 5-6 day/week for 6 weeks. The exercise program was designed to result in an energy expenditure of 1500-2500 kcal/day.</description>
    <arm_group_label>Obese intervention group</arm_group_label>
    <other_name>diet restriction</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Participants aged 7-17 years&#xD;
&#xD;
          2. Participants satisfied the obesity diagnosis criteria is based on &quot;Body mass index&#xD;
             reference standards for the screening of overweight and obesity in Chinese children&#xD;
             and adolescents&quot; released in 2004, with cut-off points of p(95) for obesity&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Metabolic disease&#xD;
&#xD;
          2. Gastrointestinal disease&#xD;
&#xD;
          3. Cardiac disease&#xD;
&#xD;
          4. Taking medications which affected energy expenditure&#xD;
&#xD;
          5. Losing weight in the past three months whether by diet, taking weight-loss medication&#xD;
             or more physical exercise than normal&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>7 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Min Hu, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Guangzhou Sport University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Junhao Huang, PhD</last_name>
    <phone>+86 (0)20 3802 5087</phone>
    <email>junhaohuang2006@hotmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Dan Wang</last_name>
    <phone>+86 (0)20 3802 5087</phone>
    <email>17880383@qq.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Guangzhou Sport University</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Junhao Huang, PhD</last_name>
      <phone>+86 (0)20 3802 5087</phone>
      <email>junhaohuang2006@hotmail.com</email>
    </contact>
    <investigator>
      <last_name>Min Hu, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>July 2, 2017</study_first_submitted>
  <study_first_submitted_qc>December 3, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 4, 2018</study_first_posted>
  <last_update_submitted>December 3, 2018</last_update_submitted>
  <last_update_submitted_qc>December 3, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 4, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Guangzhou Sport University</investigator_affiliation>
    <investigator_full_name>Min Hu</investigator_full_name>
    <investigator_title>Director of Guangdong Provincial Key Laboratory of Sports and Health Promotion</investigator_title>
  </responsible_party>
  <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/NCT03762629
org study id: Trial2017.1
nct id: NCT03762629
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Prevalence rates of childhood obesity have reached alarming levels. As childhood obesity may
      already be associated with serious comorbidities, obese adolescents are at significantly
      higher risk for obesity and increased morbidity and mortality during adulthood. Combined
      lifestyle interventions, which include regular physical activity and dietary restriction,
      have been shown to result in most significant improvements in cardiovascular function and
      their associated factors in the pediatric and adolescent population with obesity. The aim of
      this study is to investigate the effects of a combined exercise and diet intervention on
      cardiovascular function and their associated factors in obese children.
Sixty obese children and adolescents will complete a 6-week program of exercise and diet
      intervention. Thirty normal-weight children and adolescents will be recruited as control
      group. Clinical characteristics, body composition, blood biochemistry, and circulating irisin
      levels of the subjects will be measured before and after 6-week intervention. Endothelial
      function will be assessed by a flow-mediated dilation test. Circulating exosome-derived
      miRNAs, exercise-induced epigenetic modifications, circulating irisin levels irisin
      concentration in plasma and arterial stiffness as well as cardiac autonomic function will be
      investigated before and after the 6-week intervention. Fecal samples were collected before
      and after the 6-week intervention for analysis of the compositional and functional changes in
      the human gut microbiota.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Change from flow-mediated dilation (FMD) at 6 weeks
time frame: before and after the 6-week intervention
description: for brachial endothelial function assessment
measure: Change from circulating exosome-derived miRNAs at 6 weeks
time frame: before and after the 6-week intervention
description: exosome-secreted miRNA levels in plasma
measure: Change from circulating irisin levels at 6 weeks
time frame: before and after the 6-week intervention
description: irisin concentration in plasma
measure: Change from pulse wave velocity at 6 weeks
time frame: before and after the 6-week intervention
description: for arterial stiffness assessment
measure: Change from heart rate variability at 6 weeks
time frame: before and after the 6-week intervention
description: for cardiac autonomic function assessment
measure: Change from the composition of gut microbiota at 6 weeks
time frame: before and after the 6-week intervention
description: the composition of gut microbiota in fecal samples
measure: Change from short chain fatty acids (SCFAs) concentractions at 6 weeks
time frame: before and after the 6-week intervention
description: short chain fatty acids (SCFAs) concentractions in fecal samples
arm group label: Obese intervention group
arm group type: Experimental
description: Obese children were received exercise and diet intervention for 6 weeks.
arm group label: Normal weight control group
arm group type: No Intervention
description: Normal weight children were recruited as a control group without any intervention.
intervention type: Behavioral
intervention name: Exercise
description: Subjects were provided with energy-restricted diets of 1300-2200 kcal/day based on weight. The energy percentages provided by protein, fat and carbohydrate were 20%, 20% and 60%, respectively, while energy distributions at breakfast, lunch and dinner were 30%, 40% and 30%, respectively. Subjects performed a series of endurance exercise such as bicycling, walking, running, dancing and ball games for 5 hour/day, supplemented with resistance exercise. Training interventions were performed 5-6 day/week for 6 weeks. The exercise program was designed to result in an energy expenditure of 1500-2500 kcal/day.
arm group label: Obese intervention group
other name: diet restriction
criteria: 
gender: All
minimum age: 7 Years
maximum age: 17 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Min Hu, PhD
role: Principal Investigator
affiliation: Guangzhou Sport University
last name: Junhao Huang, PhD
phone: +86 (0)20 3802 5087
email: junhaohuang2006@hotmail.com
last name: Dan Wang
phone: +86 (0)20 3802 5087
email: 17880383@qq.com
facility: 
status: Recruiting
contact: 
investigator: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Guangzhou Sport University
investigator full name: Min Hu
investigator title: Director of Guangdong Provincial Key Laboratory of Sports and Health Promotion
mesh term: Obesity
mesh term: Pediatric Obesity