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

Childhood Obesity Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03762629
• Other study ID #: Trial2017.1
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2017
• Est. completion date: December 31, 2018

Study information

• Verified date: December 2018
• Source: Guangzhou Sport University
• Contact: Junhao Huang, PhD
• Phone: +86 (0)20 3802 5087
• Email: junhaohuang2006[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Adolescent Obesity
• Childhood Obesity
• Obesity
• Pediatric Obesity

Intervention

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.

Locations

Country	Name	City	State
China	Guangzhou Sport University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangzhou Sport University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change from the composition of gut microbiota at 6 weeks	the composition of gut microbiota in fecal samples	before and after the 6-week intervention
Other	Change from short chain fatty acids (SCFAs) concentractions at 6 weeks	short chain fatty acids (SCFAs) concentractions in fecal samples	before and after the 6-week intervention
Primary	Change from flow-mediated dilation (FMD) at 6 weeks	for brachial endothelial function assessment	before and after the 6-week intervention
Secondary	Change from circulating exosome-derived miRNAs at 6 weeks	exosome-secreted miRNA levels in plasma	before and after the 6-week intervention
Secondary	Change from circulating irisin levels at 6 weeks	irisin concentration in plasma	before and after the 6-week intervention
Secondary	Change from pulse wave velocity at 6 weeks	for arterial stiffness assessment	before and after the 6-week intervention
Secondary	Change from heart rate variability at 6 weeks	for cardiac autonomic function assessment	before and after the 6-week intervention