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Digestion of Gluten in the Presence of Enzymes

NCT04489810 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2025-04-10

No results posted yet for this study

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.

Conditions

  • Main Focus: Gluten and Starch Digestibility

Interventions

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

Sponsors & Collaborators

  • Teagasc

    collaborator INDUSTRY

  • Atlantia Food Clinical Trials

    collaborator INDUSTRY

  • The Archer-Daniels-Midland Company

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-10-19
Primary Completion
2021-04-08
Completion
2021-04-08

Countries

  • Ireland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04489810 on ClinicalTrials.gov