Digestion of Gluten in the Presence of Enzymes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-19

Study Completion Date

2021-04-08

Brief Summary

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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.

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Detailed Description

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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 unpublished).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.

Conditions

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Main Focus: Gluten and Starch Digestibility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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 Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Meal A + Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Maltodextrin capsule manufactured to mimic the Elevase® and DE111® capsules

Meal A

Intervention Type OTHER

Oatmeal porridge - serving of cooked oats containing 50g of carbohydrates (excluding sugars); Wheat cereal - serving of wheat cereal providing 1g of gluten; Water - 125 mL

Meal A + Elevase®

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

Group Type EXPERIMENTAL

Elevase®

Intervention Type DIETARY_SUPPLEMENT

1 capsule containing 350 mg of Elevase®

Meal A

Intervention Type OTHER

Oatmeal porridge - serving of cooked oats containing 50g of carbohydrates (excluding sugars); Wheat cereal - serving of wheat cereal providing 1g of gluten; Water - 125 mL

Meal A + DE111®

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

Group Type EXPERIMENTAL

DE111®

Intervention Type DIETARY_SUPPLEMENT

1 capsule containing Bacillus subtilis DE111

Meal A

Intervention Type OTHER

Oatmeal porridge - serving of cooked oats containing 50g of carbohydrates (excluding sugars); Wheat cereal - serving of wheat cereal providing 1g of gluten; Water - 125 mL

Meal B + Placebo

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

Group Type EXPERIMENTAL

Placebo

Intervention Type DIETARY_SUPPLEMENT

Maltodextrin capsule manufactured to mimic the Elevase® and DE111® capsules

Meal B

Intervention Type OTHER

Refrigerated oatmeal - serving of refrigerated oats containing 50g of carbohydrates (excluding sugars); Wheat cereal - serving of wheat cereal providing 1g of gluten; Water - 125 mL

Interventions

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Placebo

Maltodextrin capsule manufactured to mimic the Elevase® and DE111® capsules

Intervention Type DIETARY_SUPPLEMENT

Elevase®

1 capsule containing 350 mg of Elevase®

Intervention Type DIETARY_SUPPLEMENT

DE111®

1 capsule containing Bacillus subtilis DE111

Intervention Type DIETARY_SUPPLEMENT

Meal A

Oatmeal porridge - serving of cooked oats containing 50g of carbohydrates (excluding sugars); Wheat cereal - serving of wheat cereal providing 1g of gluten; Water - 125 mL

Intervention Type OTHER

Meal B

Refrigerated oatmeal - serving of refrigerated oats containing 50g of carbohydrates (excluding sugars); Wheat cereal - serving of wheat cereal providing 1g of gluten; Water - 125 mL

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes