Status:
COMPLETED
Digestion of Gluten in the Presence of Enzymes
Lead Sponsor:
The Archer-Daniels-Midland Company
Collaborating Sponsors:
Teagasc
Atlantia Food Clinical Trials
Conditions:
Main Focus: Gluten and Starch Digestibility
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
This study evaluates the impact of two dietary supplements (Elevase® and DE111®) and of oatmeal properties on the digestion of gluten and starch and on the glycemic response.
Detailed Description
RATIONALE 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. Elevas...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 19 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 8 2021
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT04489810
Start Date
October 19 2020
End Date
April 8 2021
Last Update
April 10 2025
Active Locations (1)
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1
Atlantia Food Clinical Trials
Cork, Cork, Ireland