Clinical Trials Directory

Trials / Unknown

UnknownNCT03762629

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

Effects of Exercise Training and Diet Restriction on Cardiovascular Function and Their Related Factors in Obese Chinese Children and Adolescents: an Intervention Study

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
90 (estimated)
Sponsor
Guangzhou Sport University · Academic / Other
Sex
All
Age
7 Years – 17 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALExerciseSubjects 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.

Timeline

Start date
2017-07-01
Primary completion
2018-12-31
Completion
2018-12-31
First posted
2018-12-04
Last updated
2018-12-04

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT03762629. Inclusion in this directory is not an endorsement.