Digestion of Gluten in the Presence of Enzymes

  • STATUS
    Recruiting
  • participants needed
    15
  • sponsor
    Deerland Enzymes
Updated on 19 February 2024

Summary

This study evaluates 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.

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.

Glutalytic, 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 unpublished).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), Glutalytic 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.

Details
Condition Main Focus: Gluten and Starch Digestibility
Age 18years - 75years
Treatment Placebo, Glutalytic®, DE111®, Meal A, Meal B
Clinical Study IdentifierNCT04489810
SponsorDeerland Enzymes
Last Modified on19 February 2024

Eligibility

Yes No Not Sure

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
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