- ICH GCP
- US-Register für klinische Studien
- Klinische Studie 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
Studienübersicht
Status
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Voraussichtlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
-
-
Ontario
-
Toronto, Ontario, Kanada, M5BW8
- St. Michael's
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Zuteilung: Zufällig
- Interventionsmodell: Crossover-Aufgabe
- Maskierung: Verdreifachen
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Experimental: 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
|
Sonstiges: 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
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Sensory Evaluation
Zeitfenster: 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
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Satiety Score
Zeitfenster: 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
|
Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Safety
Zeitfenster: 3 montsh
|
Safety will monitored using a symptoms questionnaire.
|
3 montsh
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Vladimir Vuksan, PhD, St. Michael's & University of Toronto
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Voraussichtlich)
Studienabschluss (Voraussichtlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- White Line
- 12-379C (Andere Kennung: St. Michael's Hospital Research Ethics Board)
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