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
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.
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
활성 비교기: Counseling on low glycemic index diet
One arm would be counseling on low glycemic index diet, while another arm is the conventional diet
|
dietitian interview and counselling for the low glycemic index diet group
|
|
간섭 없음: Control (Usual Care)
Conventional diet
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
body mass index
기간: 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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
other parameters of body composition
기간: change from baseline to 12 months
|
|
change from baseline to 12 months
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Alice Kong, FRCP, Chinese University of Hong Kong
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정된)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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