- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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
Studieöversikt
Status
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Förväntat)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Ontario
-
Toronto, Ontario, Kanada, M5BW8
- St. Michael's
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Trippel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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
|
|
Övrig: 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
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Sensory Evaluation
Tidsram: 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
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Satiety Score
Tidsram: 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
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Safety
Tidsram: 3 montsh
|
Safety will monitored using a symptoms questionnaire.
|
3 montsh
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Vladimir Vuksan, PhD, St. Michael's & University of Toronto
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- White Line
- 12-379C (Annan identifierare: St. Michael's Hospital Research Ethics Board)
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