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.
| Status | Not yet recruiting |
| Enrollment | 280 |
| Est. completion date | June 2013 |
| Est. primary completion date | December 2012 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 15 Years to 18 Years |
| Eligibility |
Inclusion Criteria: - Age between 15 and 18 years (inclusive) - Male or female of Chinese ethnicity - Body mass index >/= 95th percentile of Hong Kong local age- and sex-specific reference - No major medical illness - Not on any chronic medications - Post-pubertal as ascertained by clinical assessment by endocrinologist - Willingness to give written informed consent by participants and his/her parents/guardian Exclusion criteria: - Concurrent participation in any clinical trial, dietary intervention or weight loss program - Concomitant intake of weight reducing agent - Active and uncontrolled endocrine diseases including hypo- or hyperthyroidism, Cushing's syndrome, diabetes mellitus, etc. - Significant renal impairment, defined as serum creatinine >150 umol/L and/or estimated glomerular filtration rate <60ml/min/1.73m2 - Significant liver impairment, defined as >2 times upper limit of alanine aminotransferase and asparate aminotransferase levels - Gastrointestinal problems that would prevent them from following the test diets - Active malignant disease - Pregnant or lactating - Any medical illness or condition including known non-compliance, as judged by the investigators as ineligible to participate the study |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Hong Kong | Clinical Trial Centre, The Chinese University of Hong Kong, Prince of Wales Hospital | Shatin, Hong Kong |
| Lead Sponsor | Collaborator |
|---|---|
| Chinese University of Hong Kong |
Hong Kong,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | body mass index | body mass index= body weight (kg) divided by square of body height (m2) | change from baseline to 12 months | No |
| Secondary | other parameters of body composition | waist circumference body fat percentage |
change from baseline to 12 months | No |