- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01898026
Soluble Fibre Enriched CHO Food Study
Development of Palatable Soluble Fibre Containing Carbohydrate Foods and Its Effects on Postprandial Blood Glucose Response in Healthy Individuals
Aperçu de l'étude
Statut
Les conditions
Description détaillée
Literature to date points to beneficial glycemic effects from consumption of soluble fibre; however, whole grain products consumption is below recommendations possibly due to the presence of unappealing characteristic organoleptic properties. White, refined products are still the choice of the general public. As such, we propose to investigate the feasibility of increasing health benefits of commonly consumed white, refined carbohydrate products by incorporating a soluble fibre blend.
This research is important to determine the feasibility of developing fibre enriched carbohydrate foods that maintains the original organoleptic properties and is effective in reducing postprandial blood glucose response.
35 subjects will be recruited in phase I to complete a sensory evaluation on the test foods. Following tasting of the control and fibre-enriched samples, data on each subjects' liking or disliking will be collected through a 9-point hedonic scale.
An acute crossover RCT will be conducted in phase II by 10 healthy individuals. Subjects will be randomized to consume one the treatments at each visit and blood glucose levels over 120min and satiety scores will be measured.
Type d'étude
Inscription (Anticipé)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
Ontario
-
Toronto, Ontario, Canada, M5BW8
- St. Michael's
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Normotensive (SBP<140mmHg, DBP <90mmHg)
- BMI 18.5 - 25 kg/m2
- Post-menopausal or not pregnant women
Exclusion Criteria:
- Allergy or sensitivity to test meals
- Swallowing difficulties
- Chronic use of medications or fibre
- GI conditions affecting stomach pH
- Must not be enrolled in another study
- History of liver or kidney disease, diabetes, hypertension, stroke or myocardial infarctions, thyroid disease, celiac /gastrointestinal disease, HIV positive or AIDS
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Tripler
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: PGX
samples of white bread, mashed potatoes, muffin, hot breakfast cereal with the addition of soluble fibre blend
|
Samples of white bread, with or without the addition of PGX fibre blend
samples of mashed potatoes, with or without the addition of soluble fibre blend
Samples of muffins, with or without the addition of PGX fibre blend
Samples of hot breakfast cereal without the addition of soluble fibre blend
|
|
Autre: Control
samples of white bread, mashed potatoes, muffin, hot breakfast cereal without the addition of soluble fibre blend
|
Samples of white bread, with or without the addition of PGX fibre blend
samples of mashed potatoes, with or without the addition of soluble fibre blend
Samples of muffins, with or without the addition of PGX fibre blend
Samples of hot breakfast cereal without the addition of soluble fibre blend
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Sensory Evaluation
Délai: 1 month
|
Subjects will be recruited in phase I to complete a sensory evaluation on the test foods.
Following tasting of the control and fibre-enriched samples, data on each subjects' liking or disliking will be collected through a 9-point hedonic scale.
|
1 month
|
|
Postprandial Glycemia
Délai: 3 months
|
Subjects will be randomized to consume one of the 8 interventions at each visit and blood glucose levels over 120min and satiety scores will be measured.
|
3 months
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Satiety Score
Délai: 3 months
|
The incorporation of viscous soluble fibre in commonly consumed carbohydrate foods will result in increase in subjective satiety compared to non soluble fibre enriched products.
Satiety will be measured using a satiety questionnaire in which you will answer four questions about how full you feel.
|
3 months
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Safety
Délai: 3 montsh
|
Safety will monitored using a symptoms questionnaire.
|
3 montsh
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Vladimir Vuksan, PhD, St. Michael's & University of Toronto
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
Autres numéros d'identification d'étude
- White Line
- 12-379C (Autre identifiant: St. Michael's Hospital Research Ethics Board)
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