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
Panoramica dello studio
Stato
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Anticipato)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Ontario
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Toronto, Ontario, Canada, M5BW8
- St. Michael's
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione incrociata
- Mascheramento: Triplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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
|
|
Altro: 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
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Sensory Evaluation
Lasso di tempo: 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
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Satiety Score
Lasso di tempo: 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.
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3 months
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Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Safety
Lasso di tempo: 3 montsh
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Safety will monitored using a symptoms questionnaire.
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3 montsh
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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Vladimir Vuksan, PhD, St. Michael's & University of Toronto
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- White Line
- 12-379C (Altro identificatore: St. Michael's Hospital Research Ethics Board)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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