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NCT Number: NCT01278563

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

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.

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Key information

Conditions

Age range

15 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Chinese University of Hong Kong, Hong Kong, China

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Low glycemic index diet

Behavioral

dietitian interview and counselling for the low glycemic index diet group

Primary outcomes

  1. body mass index

    Time frame: change from baseline to 12 months

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

Secondary outcomes

  1. other parameters of body composition

    Time frame: change from baseline to 12 months

    • waist circumference
    • body fat percentage

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jan 19, 2011
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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