GlutDigest - Pilot Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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GlutDigest - Enzymes-assisted Gluten Digestion (Pilot Study)

Conditions
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Main Focus: Gluten and Starch Digestibility

Intervention / Treatment
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* Dietary Supplement: Glutalytic®
* Dietary Supplement: DE111®
* Other: Meal A


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject has given written informed consent Subject has an ileostomy stable for at least 3 months post-operative and shows normal stoma functions Subject is otherwise healthy Subject is available to participate in the study sessions on the proposed dates Exclusion Criteria: Subject has coeliac disease or allergy to wheat products and/or any other ingredients in the test meal and standard meals Case of obstruction of the stoma in the past 3 months Body mass index < 18 kg/m2 or > 30 kg/m2. Diagnosed mouth, throat or active gastrointestinal pathology (other than ileostomy) that may affect normal ingestion and digestion of food. History of pancreatic disease Subject is immunocompromised (HIV positive, transplant patient, on antirejection medications, on a steroid for >30 days, or chemotherapy or radiotherapy within the last year) Subject has Type 1 or Type 2 diabetes mellitus. Subject has a history of bariatric surgery. Subject has a history of drug and/or alcohol abuse at the time of enrolment Subject is currently participating in another study, or plans to participate in another study during the study period Women of child-bearing potential who do not use an acceptable method of contraception Pregnant or nursing (lactating) women

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Meal A + Glutalytic®<br>350 mg Glutalytic® capsule, taken by mouth, once, with Meal A | Dietary Supplement: Glutalytic®<br>* Glutalytic® capsule<br>Other: Meal A<br>* 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<br>|
| Experimental: Meal A + DE111®<br>350 mg DE111® capsule, taken by mouth, once, with Meal A | Dietary Supplement: DE111®<br>* DE111® capsule<br>Other: Meal A<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gluten, Starch, Digestive enzymes, Probiotics