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.
調査の概要
詳細な説明
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.
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Alice PS Kong, FRCP
- 電話番号：1558 +852 2632 2211
- メール：alicekong@cuhk.edu.hk
研究連絡先のバックアップ
- 名前：Cherry KP Chiu, RN
- 電話番号：1550 +852 2632 2211
- メール：cherrychiu@cuhk.edu.hk
研究場所
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-
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Shatin, Hong Kong、香港、Hong Kong
- Clinical Trial Centre, The Chinese University of Hong Kong, Prince of Wales Hospital
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コンタクト：
- Alice PS Kong, FRCP
- 電話番号：1558 +852 2632 2211
- メール：alicekong@cuhk.edu.hk
-
コンタクト：
- Cherry KP Chiu, RN
- 電話番号：1550 +852 2632 2211
- メール：cherrychiu@cuhk.edu.hk
-
主任研究者：
- Alice PS Kong, FRCP
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
body mass index
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
other parameters of body composition
時間枠：change from baseline to 12 months
|
|
change from baseline to 12 months
|
協力者と研究者
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。