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| Name | Class |
|---|---|
| Teagasc | INDUSTRY |
| Atlantia Food Clinical Trials | INDUSTRY |
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This is a pilot, feasibility study to evaluate, test and optimize sample analysis procedures and protocols before the full-scale, crossover study is conducted.
Two important factors can influence the proportions of gluten and starch that resist digestion: (1) enzyme availability and specificity and (2) the structural properties of the food. A complete evaluation of gluten digestion and of the impact of dietary supplements is difficult to conduct because it is not easy to obtain samples of digestive chime. The analysis of the ileal effluent of healthy ileostomy patients constitutes a non-invasive alternative to intubation techniques for the study of nutrient digestion and of the fate of probiotics in the small intestine.
The main aim of this study is to test and optimize sample analysis protocols before conducting the full-scale, crossover study which will aim at evaluating the impact of two dietary supplements (Glutalytic® and DE111®) and of oatmeal properties on the digestion of gluten and starch and on the glycemic response.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Meal A + Glutalytic® | Experimental | 350 mg Glutalytic® capsule, taken by mouth, once, with Meal A |
|
| Meal A + DE111® | Experimental | 350 mg DE111® capsule, taken by mouth, once, with Meal A |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glutalytic® | Dietary Supplement | Glutalytic® capsule |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Undigested wheat protein after each treatment | Difference between the mean concentration of undigested wheat protein in ileal effluent samples. | 9-hour period after the test meal |
| Measure | Description | Time Frame |
|---|---|---|
| Vegetative DE111 cells | Mean concentration of DE111® cells recovered in the ileal effluent samples. | 9-hour period after the test meal |
| Glycemic response | Difference between the mean area under the glucose concentration (measured in the interstitial fluid) curves following each treatment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atlantia Food Clinical Trials | Cork | Ireland |
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| DE111® |
| Dietary Supplement |
DE111® capsule |
|
| Meal A | Other | Oatmeal porridge - serving of oat porridge (cooked) containing 50g of carbohydrates (excluding sugars); Wheat cereal - serving of wheat cereal providing 1g of gluten; Water - 125 mL |
|
| At baseline, and at different time-points in the 9-hour period after consumption of the test meal. |
| Undigested starch | Difference between the mean concentration of undigested starch in ileal effluent samples. | 9-hour period after the test meal |
| Undigested food particles | Pictures of undigested foods particles and microscopy will be combined for a combined assessment of macro- and micro- structural characteristics of the food particles recovered in ileal effluent samples. | 9-hour period after the test meal |