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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Anticipé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Alice PS Kong, FRCP
- Numéro de téléphone: 1558 +852 2632 2211
- E-mail: alicekong@cuhk.edu.hk
Sauvegarde des contacts de l'étude
- Nom: Cherry KP Chiu, RN
- Numéro de téléphone: 1550 +852 2632 2211
- E-mail: cherrychiu@cuhk.edu.hk
Lieux d'étude
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Shatin, Hong Kong, Hong Kong, Hong Kong
- Clinical Trial Centre, The Chinese University of Hong Kong, Prince of Wales Hospital
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Contact:
- Alice PS Kong, FRCP
- Numéro de téléphone: 1558 +852 2632 2211
- E-mail: alicekong@cuhk.edu.hk
-
Contact:
- Cherry KP Chiu, RN
- Numéro de téléphone: 1550 +852 2632 2211
- E-mail: cherrychiu@cuhk.edu.hk
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Chercheur principal:
- Alice PS Kong, FRCP
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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body mass index
Délai: change from baseline to 12 months
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body mass index= body weight (kg) divided by square of body height (m2)
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change from baseline to 12 months
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
other parameters of body composition
Délai: change from baseline to 12 months
|
|
change from baseline to 12 months
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Collaborateurs et enquêteurs
Parrainer
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- RGC467410
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