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

January 18, 2011 updated by: Chinese University of Hong Kong

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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:

  1. To study changes of body mass index, body fat percentage, insulin secretion, insulin resistance and obesity associated cardiometabolic factors;
  2. To explore underlying neurohormonal mechanisms associated with these changes in both short- and long-term.

Study Type

Interventional

Enrollment (Anticipated)

280

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Hong Kong
      • Shatin, Hong Kong, Hong Kong, Hong Kong
        • Clinical Trial Centre, The Chinese University of Hong Kong, Prince of Wales Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Alice PS Kong, FRCP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
body mass index
Time Frame: change from baseline to 12 months
body mass index= body weight (kg) divided by square of body height (m2)
change from baseline to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
other parameters of body composition
Time Frame: change from baseline to 12 months
  1. waist circumference
  2. body fat percentage
change from baseline to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Anticipated)

December 1, 2012

Study Completion (Anticipated)

June 1, 2013

Study Registration Dates

First Submitted

January 18, 2011

First Submitted That Met QC Criteria

January 18, 2011

First Posted (Estimate)

January 19, 2011

Study Record Updates

Last Update Posted (Estimate)

January 19, 2011

Last Update Submitted That Met QC Criteria

January 18, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RGC467410

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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