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

Primary Purpose

Childhood Obesity, Adolescent Obesity

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Exercise
Sponsored by
Guangzhou Sport University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Childhood Obesity

Eligibility Criteria

7 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Guangzhou Sport UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Obese intervention group

Normal weight control group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change from flow-mediated dilation (FMD) at 6 weeks
for brachial endothelial function assessment

Secondary Outcome Measures

Change from circulating exosome-derived miRNAs at 6 weeks
exosome-secreted miRNA levels in plasma
Change from circulating irisin levels at 6 weeks
irisin concentration in plasma
Change from pulse wave velocity at 6 weeks
for arterial stiffness assessment
Change from heart rate variability at 6 weeks
for cardiac autonomic function assessment

Full Information

First Posted
July 2, 2017
Last Updated
December 3, 2018
Sponsor
Guangzhou Sport University
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1. Study Identification

Unique Protocol Identification Number
NCT03762629
Brief Title
Exercise and Diet Restriction on Cardiovascular Function in Obese Children and Adolescents
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2017 (Actual)
Primary Completion Date
December 31, 2018 (Anticipated)
Study Completion Date
December 31, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guangzhou Sport University

4. Oversight

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

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Obesity, Adolescent Obesity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Obese intervention group
Arm Type
Experimental
Arm Description
Obese children were received exercise and diet intervention for 6 weeks.
Arm Title
Normal weight control group
Arm Type
No Intervention
Arm Description
Normal weight children were recruited as a control group without any intervention.
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Other Intervention Name(s)
diet restriction
Intervention 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.
Primary Outcome Measure Information:
Title
Change from flow-mediated dilation (FMD) at 6 weeks
Description
for brachial endothelial function assessment
Time Frame
before and after the 6-week intervention
Secondary Outcome Measure Information:
Title
Change from circulating exosome-derived miRNAs at 6 weeks
Description
exosome-secreted miRNA levels in plasma
Time Frame
before and after the 6-week intervention
Title
Change from circulating irisin levels at 6 weeks
Description
irisin concentration in plasma
Time Frame
before and after the 6-week intervention
Title
Change from pulse wave velocity at 6 weeks
Description
for arterial stiffness assessment
Time Frame
before and after the 6-week intervention
Title
Change from heart rate variability at 6 weeks
Description
for cardiac autonomic function assessment
Time Frame
before and after the 6-week intervention
Other Pre-specified Outcome Measures:
Title
Change from the composition of gut microbiota at 6 weeks
Description
the composition of gut microbiota in fecal samples
Time Frame
before and after the 6-week intervention
Title
Change from short chain fatty acids (SCFAs) concentractions at 6 weeks
Description
short chain fatty acids (SCFAs) concentractions in fecal samples
Time Frame
before and after the 6-week intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Participants aged 7-17 years 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: Metabolic disease Gastrointestinal disease Cardiac disease Taking medications which affected energy expenditure Losing weight in the past three months whether by diet, taking weight-loss medication or more physical exercise than normal
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Junhao Huang, PhD
Phone
+86 (0)20 3802 5087
Email
junhaohuang2006@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Dan Wang
Phone
+86 (0)20 3802 5087
Email
17880383@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Min Hu, PhD
Organizational Affiliation
Guangzhou Sport University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Guangzhou Sport University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Junhao Huang, PhD
Phone
+86 (0)20 3802 5087
Email
junhaohuang2006@hotmail.com
First Name & Middle Initial & Last Name & Degree
Min Hu, PhD

12. IPD Sharing Statement

Citations:
PubMed Identifier
33365012
Citation
Huang J, Liao J, Fang Y, Deng H, Yin H, Shen B, Hu M. Six-Week Exercise Training With Dietary Restriction Improves Central Hemodynamics Associated With Altered Gut Microbiota in Adolescents With Obesity. Front Endocrinol (Lausanne). 2020 Dec 7;11:569085. doi: 10.3389/fendo.2020.569085. eCollection 2020.
Results Reference
derived
PubMed Identifier
32072570
Citation
Liao J, Huang J, Wang S, Xiang M, Wang D, Deng H, Yin H, Xu F, Hu M. Effects of exercise and diet intervention on appetite-regulating hormones associated with miRNAs in obese children. Eat Weight Disord. 2021 Mar;26(2):457-465. doi: 10.1007/s40519-020-00869-9. Epub 2020 Feb 18.
Results Reference
derived

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

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