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| Name | Class |
|---|---|
| National University Hospital, Singapore | OTHER |
| National University of Singapore | OTHER |
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Whilst a cause-and-effect relationship between consumption of oat ß-glucans and reduction in PPGR has been demonstrated, little is understood about its:
The proposed study is a randomised, double blind, controlled, crossover trial to investigate the postprandial effects on glycemic response and related biomarkers/biological surrogates in five test product beverages:
This study will investigate the post-prandial effects of five test products, including two controls:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oat bran fibre processed with method A | Experimental | Beverage powder with 12% oat bran processed with method A |
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| Oat bran fibre processed with method B | Experimental | Beverage powder with 12% oat bran processed with method B |
|
| Oat bran fibre processed with method C | Experimental | Beverage powder with 12% oat bran processed with method C |
|
| Minimally-processed oat bran (positive control) | Active Comparator | Beverage powder with minimally-processed oat bran (Positive Control) |
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| Readily-digestible carbohydrate (negative control) | Placebo Comparator | Beverage powder with readily digestible carbohydrate (Negative Control) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Beverage powder with 12% oat bran processed with method A | Other | 50g of beverage powder to be reconstituted with 330ml of water. Subjects will orally consume one of the five test products in a random order over the five test visits. |
| Measure | Description | Time Frame |
|---|---|---|
| Postprandial glycemic response - Area under the plasma concentration versus time curve (AUC) | Postprandial glycemic response reflected by 3-hour area under the plasma concentration versus time curve (AUC) assessed over all cross-sectional blood glucose values (i.e. T0/T15/T30/T45/T60/T90/T120/T180). | through study completion, an average of 7 months |
| Postprandial glycemic response - Peak Plasma Concentration (Cmax) | Postprandial glycemic response by the peak plasma concentration (Cmax) assessed over a 3-hour period by all cross-sectional blood glucose values (i.e. T0/T15/T30/T45/T60/T90/T120/T180). | through study completion, an average of 7 months |
| Postprandial glycemic response - Time to Peak Plasma Concentration (Tmax) | Postprandial glycemic response reflected by time to achieve the peak plasma concentration (Tmax) assessed over a 3-hour period by all cross-sectional blood glucose values (i.e. T0/T15/T30/T45/T60/T90/T120/T180). | through study completion, an average of 7 months |
| Measure | Description | Time Frame |
|---|---|---|
| Postprandial insulin response (PPIR) | PPIR over a 3-hour period | through study completion, an average of 7 months |
| Postprandial blood gastric inhibitory polypeptide (GIP) | Postprandial blood GIP over a 3-hour period |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National University Hospital | Singapore | 150054 | Singapore |
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Randomised controlled, double-blind, full crossover study conducted in an acute setting. 20 subjects will receive 5 test products, over 5 separate test visits in a crossover design.
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The test products are coded by group coding (A - E).
| Beverage powder with 12% oat bran processed with method B | Other | 50g of beverage powder to be reconstituted with 330ml of water. Subjects will orally consume one of the five test products in a random order over the five test visits. |
|
| Beverage powder with 12% oat bran processed with method C | Other | 50g of beverage powder to be reconstituted with 330ml of water. Subjects will orally consume one of the five test products in a random order over the five test visits. |
|
| Placebo Comparator: Minimally-processed oat bran (Positive Control) | Other | 50g of beverage powder to be reconstituted with 330ml of water. Subjects will orally consume one of the five test products in a random order over the five test visits. |
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| Placebo Comparator: Readily-digestible carbohydrate (negative control) | Other | 50g of beverage powder to be reconstituted with 330ml of water. Subjects will orally consume one of the five test products in a random order over the five test visits. |
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| through study completion, an average of 7 months |
| Postprandial blood glucagon-like peptide 1 (GLP-1) | Postprandial blood GLP-1 over a 3-hour period | through study completion, an average of 7 months |
| Gastric emptying rate | Gastric emptying rate measured through postprandial blood paracetamol concentration over a 4-hour period | through study completion, an average of 7 months |
| Satiety | Satiety assessed via a Visual Analogue Scale questionnaire from 0-10 over a 4-hour period, with 0 being least satiated and 10 being most satiated | through study completion, an average of 7 months |
| Gastrointestinal comfort | Gastrointestinal comfort assessed via a Visual Analogue Scale questionnaire from 0-10 over a 4-hour period, with 0 being lowest discomfort and 10 being greatest discomfort | through study completion, an average of 7 months |
| Ingredient fermentability by colonic bacteria | Fermentability by colonic bacteria will be assessed via breath hydrogen and methane (ppm) levels over a 4-hour period | through study completion, an average of 7 months |