Clinical trial NCT04489810: Digestion of Gluten in the Presence of Enzymes
Official title: GlutDigest - Enzymes-assisted Gluten Digestion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Main Focus: Gluten and Starch Digestibility
Keywords: Gluten
Starch
Digestive enzymes
Probiotics
Lead sponsor: The Archer-Daniels-Midland Company
Sponsor class: INDUSTRY
Collaborators: name: Teagasc
name: Atlantia Food Clinical Trials
First posted: 2020-07-28
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Each participant attended a clinic for one day for an acute assessment of the acute effects of treatment. This was done on the same day over 4 consecutive weeks. At each visit the participant received 1 of 4 different treatments
Primary purpose: BASIC_SCIENCE

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.

Elevase®, is a dietary supplement based on an enzyme preparation which effectively degrades gluten in vitro (Healey, Hall et al. unpublished). As it has also been found that the rate of wheat protein digestion can be increased in the presence of amylases (Smith, Pan et al. 2015), Elevase® is also enriched with amylase to aid in starch digestion.

The structural properties of food are influenced by numerous factors including meal preparation practices. Two common practices that can influence nutrient availability differently are heating vs. refrigerating (e.g. oat porridge vs. soaked and refrigerated oats).

Bacillus subtilis DE111® can produce and secrete many enzymes, including proteases, which, if secreted into the environment of the digestive tract, could support digestion and, in particular, the digestion of gluten. However, it is not clear whether diet supplementation with DE111 is a physiologically viable approach in terms of probiotic survival in the gastrointestinal tract.

PURPOSE The aims of this study are to better understand the impact of each of these factors and whether supplementation with probiotic spores is a viable option.

Eligibility criteria: 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

Primary outcomes:
measure: Undigested wheat protein
timeFrame: 9-hour period after the test meal
Secondary outcomes:
measure: Vegetative DE111 cells
timeFrame: 9-hour period after the test meal
measure: Glycemic response
timeFrame: At baseline, and at different time-points during 9 hours after after consuming the test meal.
measure: Undigested starch
timeFrame: At baseline and once every hour in the 9-hour period after consumption of the test meal.
measure: Undigested food particles
timeFrame: 9-hour period after the test meal
Other outcomes:
Locations:
city: Cork
country: Ireland
facility: Atlantia Food Clinical Trials
Study officials:
References:
citation: Smith F, Pan X, Bellido V, Toole GA, Gates FK, Wickham MS, Shewry PR, Bakalis S, Padfield P, Mills EN. Digestibility of gluten proteins is reduced by baking and enhanced by starch digestion. Mol Nutr Food Res. 2015 Oct;59(10):2034-43. doi: 10.1002/mnfr.201500262. Epub 2015 Aug 21.