A 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
Recruitment status was Not yet recruiting
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.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
|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|
- body mass index [ Time Frame: change from baseline to 12 months ] [ Designated as safety issue: No ]body mass index= body weight (kg) divided by square of body height (m2)
- other parameters of body composition [ Time Frame: change from baseline to 12 months ] [ Designated as safety issue: No ]
- waist circumference
- body fat percentage
|Study Start Date:||January 2011|
|Estimated Study Completion Date:||June 2013|
|Estimated Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
Behavioral: Low glycemic index diet
This is a 12-month randomized controlled dietary interventional trial followed by a 6-month observational period. The objectives of this study include:
- To study changes of body mass index, body fat percentage, insulin secretion, insulin resistance and obesity associated cardiometabolic factors;
- To explore underlying neurohormonal mechanisms associated with these changes in both short- and long-term.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01278563
|Contact: Alice PS Kong, FRCP||+852 2632 2211 ext firstname.lastname@example.org|
|Contact: Cherry KP Chiu, RN||+852 2632 2211 ext email@example.com|
|Clinical Trial Centre, The Chinese University of Hong Kong, Prince of Wales Hospital||Not yet recruiting|
|Shatin, Hong Kong, Hong Kong, Hong Kong|
|Contact: Alice PS Kong, FRCP +852 2632 2211 ext 1558 firstname.lastname@example.org|
|Contact: Cherry KP Chiu, RN +852 2632 2211 ext 1550 email@example.com|
|Principal Investigator: Alice PS Kong, FRCP|