Adolescence Obesity Clinical Trial
Official title:
A Randomized Controlled Trial to Investigate the Impact of a Low Glycemic Index (GI) Diet on Body Mass Index and Obesity Related Cardiovascular and Hormonal Factors in Chinese Adolescents
Epidemiological studies suggest a role for a low glycemic index (GI) diet in the management
of obesity and associated metabolic risks including diabetes. However, evidence from
long-term, randomized controlled trials exploring the relationship between low GI diet,
weight reduction and glycemia, particularly in children and adolescents, is lacking. Modern
food-processing technology has produced many food products with high GI which may contribute
to the burgeoning epidemic of obesity worldwide. Since dietary habits are shaped in early
life, adolescence is a critical period to educate our young people to acquire a healthy
eating habit to prevent obesity.
The investigators hypothesized that, in Chinese adolescents, low GI diet results in greater
reduction in body mass index and body fat percentage, enhanced insulin sensitivity and
favorable changes of cardiometabolic risk factors compared to conventional diet after 12
months of intervention.
This study is a randomized controlled trial of a low GI (<55) versus conventional Chinese
diet (GI>/=70) in adolescents (12-month intervention followed by a 6-month observational
period) to study; 1) the changes in body mass index and obesity associated changes in
cardiometabolic profile; 2) the underlying hormonal factors associated with these changes.
This is a 12-month randomized controlled dietary interventional trial followed by a 6-month
observational period. The objectives of this study include:
1. To study changes of body mass index, body fat percentage, insulin secretion, insulin
resistance and obesity associated cardiometabolic factors;
2. To explore underlying neurohormonal mechanisms associated with these changes in both
short- and long-term.
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment