Exercise and Diet Restriction on Cardiovascular Function in Obese Children and Adolescents

Sponsor
Guangzhou Sport University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03762629
Collaborator
(none)
90
1
2
18
5

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Exercise
N/A

Detailed Description

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
90 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
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
Actual Study Start Date :
Jul 1, 2017
Anticipated Primary Completion Date :
Dec 31, 2018
Anticipated Study Completion Date :
Dec 31, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Obese intervention group

Obese children were received exercise and diet intervention for 6 weeks.

Behavioral: Exercise
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.
Other Names:
  • diet restriction
  • No Intervention: Normal weight control group

    Normal weight children were recruited as a control group without any intervention.

    Outcome Measures

    Primary Outcome Measures

    1. Change from flow-mediated dilation (FMD) at 6 weeks [before and after the 6-week intervention]

      for brachial endothelial function assessment

    Secondary Outcome Measures

    1. Change from circulating exosome-derived miRNAs at 6 weeks [before and after the 6-week intervention]

      exosome-secreted miRNA levels in plasma

    2. Change from circulating irisin levels at 6 weeks [before and after the 6-week intervention]

      irisin concentration in plasma

    3. Change from pulse wave velocity at 6 weeks [before and after the 6-week intervention]

      for arterial stiffness assessment

    4. Change from heart rate variability at 6 weeks [before and after the 6-week intervention]

      for cardiac autonomic function assessment

    Other Outcome Measures

    1. Change from the composition of gut microbiota at 6 weeks [before and after the 6-week intervention]

      the composition of gut microbiota in fecal samples

    2. Change from short chain fatty acids (SCFAs) concentractions at 6 weeks [before and after the 6-week intervention]

      short chain fatty acids (SCFAs) concentractions in fecal samples

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    7 Years to 17 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    1. Participants aged 7-17 years

    2. Participants satisfied the obesity diagnosis criteria is based on "Body mass index reference standards for the screening of overweight and obesity in Chinese children and adolescents" released in 2004, with cut-off points of p(95) for obesity

    Exclusion Criteria:
    1. Metabolic disease

    2. Gastrointestinal disease

    3. Cardiac disease

    4. Taking medications which affected energy expenditure

    5. Losing weight in the past three months whether by diet, taking weight-loss medication or more physical exercise than normal

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Guangzhou Sport University Guangzhou Guangdong China 510000

    Sponsors and Collaborators

    • Guangzhou Sport University

    Investigators

    • Principal Investigator: Min Hu, PhD, Guangzhou Sport University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Min Hu, Director of Guangdong Provincial Key Laboratory of Sports and Health Promotion, Guangzhou Sport University
    ClinicalTrials.gov Identifier:
    NCT03762629
    Other Study ID Numbers:
    • Trial2017.1
    First Posted:
    Dec 4, 2018
    Last Update Posted:
    Dec 4, 2018
    Last Verified:
    Dec 1, 2018
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Dec 4, 2018