Digestion of Gluten in the Presence of Enzymes

Main Focus: Gluten and Starch Digestibility Clinical Trial

— GlutDigest  

Official title:

GlutDigest - Enzymes-assisted Gluten Digestion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04489810
• Other study ID #: Project 0470
• Status: Completed
• Phase: N/A
• Start date: October 19, 2020
• Est. completion date: April 8, 2021

Study information

• Verified date: May 2024
• Source: The Archer-Daniels-Midland Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 unpublished).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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: April 8, 2021
• Est. primary completion date: April 8, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Main Focus: Gluten and Starch Digestibility

Intervention

Dietary Supplement:
• Placebo
Maltodextrin capsule manufactured to mimic the Elevase® and DE111® capsules
• Elevase®
1 capsule containing 350 mg of Elevase®
• DE111®
1 capsule containing Bacillus subtilis DE111

Other:
• 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
• 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

Locations

Country	Name	City	State
Ireland	Atlantia Food Clinical Trials	Cork

Sponsors (3)

Lead Sponsor	Collaborator
The Archer-Daniels-Midland Company	Atlantia Food Clinical Trials, Teagasc

Country where clinical trial is conducted

Ireland, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Undigested wheat protein	Difference between the mean concentration of undigested wheat protein in ileal effluent samples.	9-hour period after the test meal
Secondary	Vegetative DE111 cells	Mean concentration of DE111® cells recovered in the ileal effluent in the vegetative state.	9-hour period after the test meal
Secondary	Glycemic response	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 during 9 hours after after consuming the test meal.
Secondary	Undigested starch	Difference between the mean concentration of undigested starch in ileal effluent samples.	At baseline and once every hour in the 9-hour period after consumption of the test meal.
Secondary	Undigested food particles	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