Digestion of Gluten in the Presence of Enzymes (GlutDigest)

The Archer-Daniels-Midland Company

Status: Completed

Conditions: Main Focus: Gluten and Starch Digestibility

Treatments: Other: Meal B; Dietary Supplement: Elevase®; Dietary Supplement: DE111®; Dietary Supplement: Placebo; Other: Meal A

Study type: Interventional

Funder types: Industry

Identifiers

NCT04489810

Project 0470

Details and patient eligibility

About

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.

Full 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 unpublished).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.

Enrollment: 11 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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11 participants in 4 patient groups, including a placebo group

Meal A + Placebo

Placebo Comparator group

Description:

350 mg Placebo capsule, taken by mouth, once, with Meal A

Treatment:

Other: Meal A

Dietary Supplement: Placebo

Meal A + Elevase®

Experimental group

Description:

350 mg Elevase® capsule, taken by mouth, once, with Meal A

Treatment:

Other: Meal A

Dietary Supplement: Elevase®

Meal A + DE111®

Experimental group

Description:

350 mg DE111® capsule, taken by mouth, once, with Meal A

Treatment:

Other: Meal A

Dietary Supplement: DE111®

Meal B + Placebo

Experimental group

Description:

350 mg Placebo capsule, taken by mouth, once, with Meal B

Treatment:

Dietary Supplement: Placebo

Other: Meal B