NCT01278563

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
285

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2011

Typical duration for not_applicable

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 18, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 19, 2011

Completed
27 days until next milestone

Study Start

First participant enrolled

February 15, 2011

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2013

Completed
Last Updated

June 25, 2026

Status Verified

January 1, 2011

Enrollment Period

2.7 years

First QC Date

January 18, 2011

Last Update Submit

June 22, 2026

Conditions

Adolescence Obesity

Keywords

Low Glycemic Index Diet

Outcome Measures

Primary Outcomes (1)

  • body mass index

    body mass index= body weight (kg) divided by square of body height (m2)

    change from baseline to 12 months

Secondary Outcomes (1)

  • other parameters of body composition

    change from baseline to 12 months

Study Arms (2)

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

Behavioral: Low glycemic index diet

Control (Usual Care)

NO INTERVENTION

Conventional diet

Interventions

Low glycemic index dietBEHAVIORAL

dietitian interview and counselling for the low glycemic index diet group

Counseling on low glycemic index diet

Eligibility Criteria

Age15 Years - 21 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

The Chinese University of Hong Kong

Hong Kong, Hong Kong, China

Location

Clinical Trial Centre, The Chinese University of Hong Kong, Prince of Wales Hospital

Hong Kong, Hong Kong

Location

Related Publications (1)

  • 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.

    PMID: 24552366DERIVED

Study Officials

  • Alice Kong, FRCP

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 18, 2011

First Posted

January 19, 2011

Study Start

February 15, 2011

Primary Completion

October 30, 2013

Study Completion

October 30, 2013

Last Updated

June 25, 2026

Record last verified: 2011-01

Locations

CN(1)HK(1)