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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

Primary Purpose

Adolescence Obesity

Status
Unknown status
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Low glycemic index diet
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adolescence Obesity focused on measuring Low Glycemic Index Diet

Eligibility Criteria

15 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

other parameters of body composition
waist circumference body fat percentage

Full Information

First Posted
January 18, 2011
Last Updated
January 18, 2011
Sponsor
Chinese University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT01278563
Brief Title
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
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2011
Overall Recruitment Status
Unknown status
Study Start Date
January 2011 (undefined)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
June 2013 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Chinese University of Hong Kong

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adolescence Obesity
Keywords
Low Glycemic Index Diet

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
280 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Low glycemic index diet
Intervention Description
dietitian interview and counselling for the low glycemic index diet group
Primary Outcome Measure Information:
Title
body mass index
Description
body mass index= body weight (kg) divided by square of body height (m2)
Time Frame
change from baseline to 12 months
Secondary Outcome Measure Information:
Title
other parameters of body composition
Description
waist circumference body fat percentage
Time Frame
change from baseline to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alice PS Kong, FRCP
Phone
+852 2632 2211
Ext
1558
Email
alicekong@cuhk.edu.hk
First Name & Middle Initial & Last Name or Official Title & Degree
Cherry KP Chiu, RN
Phone
+852 2632 2211
Ext
1550
Email
cherrychiu@cuhk.edu.hk
Facility Information:
Facility Name
Clinical Trial Centre, The Chinese University of Hong Kong, Prince of Wales Hospital
City
Shatin, Hong Kong
ZIP/Postal Code
Hong Kong
Country
Hong Kong
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alice PS Kong, FRCP
Phone
+852 2632 2211
Ext
1558
Email
alicekong@cuhk.edu.hk
First Name & Middle Initial & Last Name & Degree
Cherry KP Chiu, RN
Phone
+852 2632 2211
Ext
1550
Email
cherrychiu@cuhk.edu.hk
First Name & Middle Initial & Last Name & Degree
Alice PS Kong, FRCP

12. IPD Sharing Statement

Citations:
PubMed Identifier
24552366
Citation
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.
Results Reference
derived

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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

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