NCT04489836

GlutDigest - Pilot Study

GlutDigest - Enzymes-assisted Gluten Digestion (Pilot Study)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Deerland Enzymes · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

This is a pilot, feasibility study to evaluate, test and optimize sample analysis procedures and protocols before the full-scale, crossover study is conducted.

Detailed description

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. A complete evaluation of gluten digestion and of the impact of dietary supplements is difficult to conduct because it is not easy to obtain samples of digestive chime. The analysis of the ileal effluent of healthy ileostomy patients constitutes a non-invasive alternative to intubation techniques for the study of nutrient digestion and of the fate of probiotics in the small intestine. The main aim of this study is to test and optimize sample analysis protocols before conducting the full-scale, crossover study which will aim at evaluating 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.

Conditions

• Main Focus: Gluten and Starch Digestibility

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Glutalytic®	Glutalytic® capsule
DIETARY_SUPPLEMENT	DE111®	DE111® capsule
OTHER	Meal A	Oatmeal porridge - serving of oat porridge (cooked) containing 50g of carbohydrates (excluding sugars); Wheat cereal - serving of wheat cereal providing 1g of gluten; Water - 125 mL

Timeline

• Start date: 2020-08-31
• Primary completion: 2020-09-19
• Completion: 2020-09-19
• First posted: 2020-07-28
• Last updated: 2020-10-23

Locations

1 site across 1 country: Ireland