Status:
COMPLETED
GlutDigest - Pilot Study
Lead Sponsor:
Deerland Enzymes
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 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
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 evalua...
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 :
August 31 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 19 2020
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT04489836
Start Date
August 31 2020
End Date
September 19 2020
Last Update
October 23 2020
Active Locations (1)
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1
Atlantia Food Clinical Trials
Cork, Ireland