A Trial to Investigate the Impact of a Low Glycemic Index (GI) Diet on Body Mass Index and Obesit… (NCT01278563) | Clinical Trial Compass
CompletedNot Applicable
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
China, Hong Kong285 participantsStarted 2011-02-15
Plain-language summary
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.
Who can participate
Age range
15 Years – 21 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* School children aged 15 or above
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.