NCT04489810

Digestion of Gluten in the Presence of Enzymes

GlutDigest - Enzymes-assisted Gluten Digestion

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: The Archer-Daniels-Midland Company · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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 unpublished).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.

Conditions

• Main Focus: Gluten and Starch Digestibility

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Placebo	Maltodextrin capsule manufactured to mimic the Elevase® and DE111® capsules
DIETARY_SUPPLEMENT	Elevase®	1 capsule containing 350 mg of Elevase®
DIETARY_SUPPLEMENT	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
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

Timeline

• Start date: 2020-10-19
• Primary completion: 2021-04-08
• Completion: 2021-04-08
• First posted: 2020-07-28
• Last updated: 2025-04-10

Locations

1 site across 1 country: Ireland