Adolescence ObesityNCT01278563
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
A study testing Low glycemic index diet in people with Adolescence Obesity, run by Chinese University of Hong Kong at 2 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 15 to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- Adolescence Obesity
- What is being tested?
- Low glycemic index diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 285 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 15 Feb 2011to 30 Oct 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 21 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Hong Kong1 site
Clinical Trial Centre, The Chinese University of Hong Kong, Prince of Wales Hospital
Hong Kong
About this study
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.
Read the detailed description
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.
- Conditions
- Adolescence Obesity
- Being tested
- Low glycemic index diet
- Keywords
- Low Glycemic Index Diet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low glycemic index dietBehavioural
dietitian interview and counselling for the low glycemic index diet group
| Study group | Role | What they receive |
|---|---|---|
| Counseling on low glycemic index diet | Active comparator | One arm would be counseling on low glycemic index diet, while another arm is the conventional diet Receives: Behavioral: Low glycemic index diet |
| Control (Usual Care) | No intervention | Conventional diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
body mass index
body mass index= body weight (kg) divided by square of body height (m2)
Measured: change from baseline to 12 months
Secondary outcomes (1)
other parameters of body composition
- waist circumference
- body fat percentage
Measured: change from baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2011 (estimated)
- Study start15 Feb 2011
- Primary completion30 Oct 2013
- Study completion30 Oct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adolescence ObesityStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 285 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alice Pik Shan KONG, Chinese University of Hong Kong
- Investigators
- Alice Kong, FRCP, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01278563
- Sponsor's protocol ID
- RGC467410
- Status last verified
- Jan 2011
- First submitted
- 18 Jan 2011
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Kong AP, Choi KC, Chan RS, Lok K, Ozaki R, Li AM, Ho CS, Chan MH, Sea M, Henry CJ, Chan JC, Woo J. A randomized controlled trial to investigate the impact of a low glycemic index (GI) diet on body mass index in obese adolescents. BMC Public Health. 2014 Feb 19;14:180. doi: 10.1186/1471-2458-14-180.
PubMed 24552366
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01278563
- Acronym / sponsor ID
- RGC467410
- Conditions
- Adolescence Obesity
- Keywords
- Low Glycemic Index Diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 285 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 15 Feb 2011 (actual)
- Primary completion
- 30 Oct 2013 (actual)
- Study completion
- 30 Oct 2013 (actual)
- First posted
- 19 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Counseling on low glycemic index diet | Active comparator | Behavioral: Low glycemic index dietOne arm would be counseling on low glycemic index diet, while another arm is the conventional diet |
| Control (Usual Care) | No intervention | –Conventional diet |
Who may qualify
- Ages
- 15 to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low glycemic index dietdietitian interview and counselling for the low glycemic index diet group | Behavioural | Counseling on low glycemic index diet |
Primary outcome
body mass index
Time frame: change from baseline to 12 months
body mass index= body weight (kg) divided by square of body height (m2)
1 secondary outcome
other parameters of body composition
Time frame: change from baseline to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Derived from this study: PubMed 24552366Kong AP, Choi KC, Chan RS, Lok K, Ozaki R, Li AM, Ho CS, Chan MH, Sea M, Henry CJ, Chan JC, Woo J. A randomized controlled trial to investigate the impact of a low glycemic index (GI) diet on body mass index in obese adolescents. BMC Public Health. 2014 Feb 19;14:180. doi: 10.1186/1471-2458-14-180.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alice Kong, FRCP principal investigator
Chinese University of Hong Kong
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low glycemic index diet in people with Adolescence Obesity, run by Chinese University of Hong Kong at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China, Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
body mass index (time frame: change from baseline to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01278563, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.