Digestion of Gluten in the Presence of Enzymes

NCT04489810 | Completed

• 1 other identifier: Project 0470
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Gluten; Starch; Digestive enzymes; Probiotics

Outcome Measures

Primary Outcomes (1)

• Undigested wheat protein

  Difference between the mean concentration of undigested wheat protein in ileal effluent samples.

  9-hour period after the test meal

Secondary Outcomes (4)

• Vegetative DE111 cells

  9-hour period after the test meal

• Glycemic response

  At baseline, and at different time-points during 9 hours after after consuming the test meal.

• Undigested starch

  At baseline and once every hour in the 9-hour period after consumption of the test meal.

• Undigested food particles

  9-hour period after the test meal

Study Arms (4)

Meal A + Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo; Other: Meal A

Meal A + Elevase®

EXPERIMENTAL

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

Dietary Supplement: Elevase®; Other: Meal A

Meal A + DE111®

EXPERIMENTAL

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

Dietary Supplement: DE111®; Other: Meal A

Meal B + Placebo

EXPERIMENTAL

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

Dietary Supplement: Placebo; Other: Meal B

Interventions

Placebo DIETARY_SUPPLEMENT

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

Meal A + Placebo; Meal B + Placebo

Elevase® DIETARY_SUPPLEMENT

1 capsule containing 350 mg of Elevase®

Meal A + Elevase®

DE111® DIETARY_SUPPLEMENT

1 capsule containing Bacillus subtilis DE111

Meal A + DE111®

Meal A 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®; Meal A + Elevase®; Meal A + Placebo

Meal B 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

Meal B + Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Archer-Daniels-Midland Company: lead
• Teagasc: collaborator
• Atlantia Food Clinical Trials: collaborator

Study Sites (1)

Atlantia Food Clinical Trials

Cork, Cork, Ireland

Location

Related 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.

  PMID: 26202208 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: July 22, 2020
• First Posted: July 28, 2020
• Study Start: October 19, 2020
• Primary Completion: April 8, 2021
• Study Completion: April 8, 2021
• Last Updated: April 10, 2025

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)