- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02075788
Millet Products Study - Investigation of Glycemic Index and Satiety
Aperçu de l'étude
Statut
Les conditions
Description détaillée
The purpose of this study is to investigate how millet incorporation into different baked product types (i.e. an extruded snack versus a biscuit) influences glycemic response and satiety.
This project will examine the effect of millet, on glycemic response and satiety. To determine the effect of product matrix and processing methods, testing will be done using an extruded snack, porridge, a couscous-like product and a biscuit.
All product servings will provide 50 g of available carbohydrate and will be consumed by participants within 10 minutes.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
Ontario
-
Guelph, Ontario, Canada, N1G2W1
- Human Nutraceutical Research Unit, University of Guelph
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Men, age 19-40, non-smoking
- Normal fasting plasma glucose (<5.6 mmol/L but not below 3.6 mmol/L)
- Normal glucose tolerance (evaluated by a 75 g oral glucose test, i.e. <7.8 mmol/L but not below 3.6 mmol/L)
- BMI ranging from 18.5 to 29.9 kg/m2
Exclusion Criteria:
- Insulin resistance (IR) will be calculated from fasting glucose and insulin values using the Homeostasis Assessment Model 2 (HOMA2). A HOMA2-IR value of greater than 1.0 will be considered indicative of insulin resistance (Levy J.C. et al. 1998).
- Regular consumption of millet as defined by questionnaire at screening defined as more than 1x per week
- Smoking or use of recreational drugs
- Heavy alcohol use (defined as typically >14 drinks per week or >4 drinks on one occasion)
- Very low fibre consumption as assessed by 24 hour food diary and self-reported fruit/vegetable/whole grain servings.
- Restrained eater as defined by the questionnaire at screening (Three Factor Eating Questionnaire, Stunkard et al.,1985)
- Food neophobic defined by Food Neophobia Scale questionnaire
- Unusual sleep patterns or irregular breakfast consumption
- Recent (i.e. >4 kg in previous 3 months) or intended weight loss or gain
- Food allergies or any life-threatening allergy (food or otherwise)
- Inflammatory bowel disease or other gastrointestinal disorders
- Use of drugs which influence carbohydrate metabolism
- Training or elite athletes
- Inability to adhere to Study Protocols
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Science basique
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur placebo: Commercial white bread
All product servings will provide 50 g of available carbohydrate and will be consumed by participants within 10 minutes.
|
|
|
Expérimental: Millet based products (porridge etc.)
All product servings will provide 50 g of available carbohydrate and will be consumed by participants within 10 minutes.
|
|
|
Comparateur actif: Corn based products (porridge etc.)
All product servings will provide 50 g of available carbohydrate and will be consumed by participants within 10 minutes.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
Determination of glycemic index based on collection of capillary plasma glucose
Délai: Outcome measures will be assessed at fasting, and postprandially at 15, 30, 45, 60, 90 and 120 minutes
|
Outcome measures will be assessed at fasting, and postprandially at 15, 30, 45, 60, 90 and 120 minutes
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
|
Self reported ratings of satiety
Délai: Outcome measures will be assessed at fasting, and postprandially every 30 minutes over 2 hours
|
Outcome measures will be assessed at fasting, and postprandially every 30 minutes over 2 hours
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
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
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 13AP004
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .