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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by Chinese University of Hong Kong.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01278563
First received: January 18, 2011
Last updated: NA
Last verified: January 2011
History: No changes posted
  Purpose

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.


Condition Intervention
Adolescence Obesity
Behavioral: Low glycemic index diet

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Chinese University of Hong Kong:

Primary Outcome Measures:
  • body mass index [ Time Frame: change from baseline to 12 months ] [ Designated as safety issue: No ]
    body mass index= body weight (kg) divided by square of body height (m2)


Secondary Outcome Measures:
  • other parameters of body composition [ Time Frame: change from baseline to 12 months ] [ Designated as safety issue: No ]
    1. waist circumference
    2. body fat percentage


Estimated Enrollment: 280
Study Start Date: January 2011
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: Low glycemic index diet
    dietitian interview and counselling for the low glycemic index diet group
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.
  Eligibility

Ages Eligible for Study:   15 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01278563

Contacts
Contact: Alice PS Kong, FRCP +852 2632 2211 ext 1558 alicekong@cuhk.edu.hk
Contact: Cherry KP Chiu, RN +852 2632 2211 ext 1550 cherrychiu@cuhk.edu.hk

Locations
Hong Kong
Clinical Trial Centre, The Chinese University of Hong Kong, Prince of Wales Hospital Not yet recruiting
Shatin, Hong Kong, Hong Kong, Hong Kong
Contact: Alice PS Kong, FRCP    +852 2632 2211 ext 1558    alicekong@cuhk.edu.hk   
Contact: Cherry KP Chiu, RN    +852 2632 2211 ext 1550    cherrychiu@cuhk.edu.hk   
Principal Investigator: Alice PS Kong, FRCP         
Sponsors and Collaborators
Chinese University of Hong Kong
  More Information

No publications provided by Chinese University of Hong Kong

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Alice Pik Shan KONG, The Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT01278563     History of Changes
Other Study ID Numbers: RGC467410
Study First Received: January 18, 2011
Last Updated: January 18, 2011
Health Authority: Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee

Keywords provided by Chinese University of Hong Kong:
Low Glycemic Index Diet

Additional relevant MeSH terms:
Obesity
Body Weight
Nutrition Disorders
Overnutrition
Overweight
Signs and Symptoms

ClinicalTrials.gov processed this record on October 22, 2014