- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04489836
GlutDigest - Pilot Study (GlutDigestP)
GlutDigest - Enzymes-assisted Gluten Digestion (Pilot Study)
Study Overview
Status
Conditions
Intervention / Treatment
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 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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Cork, Ireland
- Atlantia Food Clinical Trials
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Meal A + Glutalytic®
350 mg Glutalytic® capsule, taken by mouth, once, with Meal A
|
Glutalytic® 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
|
EXPERIMENTAL: Meal A + DE111®
350 mg DE111® capsule, taken by mouth, once, with Meal A
|
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
DE111® capsule
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Undigested wheat protein after each treatment
Time Frame: 9-hour period after the test meal
|
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 |
---|---|---|
Undigested food particles
Time Frame: 9-hour period after the test meal
|
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
|
Vegetative DE111 cells
Time Frame: 9-hour period after the test meal
|
Mean concentration of DE111® cells recovered in the ileal effluent samples.
|
9-hour period after the test meal
|
Glycemic response
Time Frame: At baseline, and at different time-points in the 9-hour period after consumption of the test meal.
|
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
Time Frame: 9-hour period after the test meal
|
Difference between the mean concentration of undigested starch in ileal effluent samples.
|
9-hour period after the test meal
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Project 0470-Pilot study
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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