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

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ClinicalTrials.gov Identifier: NCT03762629
Recruitment Status : Recruiting
First Posted : December 4, 2018
Last Update Posted : December 4, 2018
Sponsor:
Information provided by (Responsible Party):
Min Hu, Guangzhou Sport University

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
Childhood Obesity Adolescent Obesity Behavioral: Exercise Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : July 1, 2017
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine


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 Name: diet restriction

No Intervention: Normal weight control group
Normal weight children were recruited as a control group without any intervention.



Primary Outcome Measures :
  1. Change from flow-mediated dilation (FMD) at 6 weeks [ Time Frame: 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 [ Time Frame: before and after the 6-week intervention ]
    exosome-secreted miRNA levels in plasma

  2. Change from circulating irisin levels at 6 weeks [ Time Frame: before and after the 6-week intervention ]
    irisin concentration in plasma

  3. Change from pulse wave velocity at 6 weeks [ Time Frame: before and after the 6-week intervention ]
    for arterial stiffness assessment

  4. Change from heart rate variability at 6 weeks [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: before and after the 6-week intervention ]
    short chain fatty acids (SCFAs) concentractions in fecal samples



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Ages Eligible for Study:   7 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03762629


Contacts
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Contact: Junhao Huang, PhD +86 (0)20 3802 5087 junhaohuang2006@hotmail.com
Contact: Dan Wang +86 (0)20 3802 5087 17880383@qq.com

Locations
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China, Guangdong
Guangzhou Sport University Recruiting
Guangzhou, Guangdong, China, 510000
Contact: Junhao Huang, PhD    +86 (0)20 3802 5087    junhaohuang2006@hotmail.com   
Principal Investigator: Min Hu, PhD         
Sponsors and Collaborators
Guangzhou Sport University
Investigators
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Principal Investigator: Min Hu, PhD Guangzhou Sport University

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Responsible Party: Min Hu, Director of Guangdong Provincial Key Laboratory of Sports and Health Promotion, Guangzhou Sport University
ClinicalTrials.gov Identifier: NCT03762629     History of Changes
Other Study ID Numbers: Trial2017.1
First Posted: December 4, 2018    Key Record Dates
Last Update Posted: December 4, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Obesity
Pediatric Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms