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

NCT01278563 | Unknown

• 1 other identifier: RGC467410
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 1

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.

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

Interventions

Low glycemic index diet BEHAVIORAL

dietitian interview and counselling for the low glycemic index diet group

Eligibility Criteria

• Age: 15 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

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

Shatin, Hong Kong, Hong Kong, 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: 24552366 DERIVED

Central Study Contacts

Alice PS Kong, FRCP

CONTACT

+852 2632 2211; alicekong@cuhk.edu.hk

Cherry KP Chiu, RN

CONTACT

+852 2632 2211; cherrychiu@cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 18, 2011
• First Posted: January 19, 2011
• Study Start: January 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: June 1, 2013
• Last Updated: January 19, 2011

Record last verified: 2011-01

Locations

HK (1)