Clinical trial NCT03762629: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Childhood Obesity
Adolescent Obesity
Lead sponsor: Guangzhou Sport University
Sponsor class: OTHER
First posted: 2018-12-04
Enrollment: 90
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: Change from flow-mediated dilation (FMD) at 6 weeks
timeFrame: before and after the 6-week intervention
Secondary outcomes:
measure: Change from circulating exosome-derived miRNAs at 6 weeks
timeFrame: before and after the 6-week intervention
measure: Change from circulating irisin levels at 6 weeks
timeFrame: before and after the 6-week intervention
measure: Change from pulse wave velocity at 6 weeks
timeFrame: before and after the 6-week intervention
measure: Change from heart rate variability at 6 weeks
timeFrame: before and after the 6-week intervention
Other outcomes:
measure: Change from the composition of gut microbiota at 6 weeks
timeFrame: before and after the 6-week intervention
measure: Change from short chain fatty acids (SCFAs) concentractions at 6 weeks
timeFrame: before and after the 6-week intervention
Locations:
city: Guangzhou
country: China
facility: Guangzhou Sport University
state: Guangdong
Study officials:
affiliation: Guangzhou Sport University
name: Min Hu, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.