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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
2
Glutalytic® capsule
DE111® capsule
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
Atlantia Food Clinical Trials
Cork, Ireland
Undigested wheat protein after each treatment
Difference between the mean concentration of undigested wheat protein in ileal effluent samples.
Time frame: 9-hour period after the test meal
Vegetative DE111 cells
Mean concentration of DE111® cells recovered in the ileal effluent samples.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 9-hour period after the test meal
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