GlutDigest - Pilot Study (GlutDigestP)

October 22, 2020 updated by: Deerland Enzymes

GlutDigest - Enzymes-assisted Gluten Digestion (Pilot Study)

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

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Cork, Ireland
        • Atlantia Food Clinical Trials

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Meal A + Glutalytic®
350 mg Glutalytic® capsule, taken by mouth, once, with Meal A
Glutalytic® capsule
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
EXPERIMENTAL: Meal A + DE111®
350 mg DE111® capsule, taken by mouth, once, with 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
DE111® capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Undigested wheat protein after each treatment
Time Frame: 9-hour period after the test meal
Difference between the mean concentration of undigested wheat protein in ileal effluent samples.
9-hour period after the test meal

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Undigested food particles
Time Frame: 9-hour period after the test meal
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
Vegetative DE111 cells
Time Frame: 9-hour period after the test meal
Mean concentration of DE111® cells recovered in the ileal effluent samples.
9-hour period after the test meal
Glycemic response
Time Frame: At baseline, and at different time-points in the 9-hour period after consumption of the test meal.
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 in the 9-hour period after consumption of the test meal.
Undigested starch
Time Frame: 9-hour period after the test meal
Difference between the mean concentration of undigested starch in ileal effluent samples.
9-hour period after the test meal

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 31, 2020

Primary Completion (ACTUAL)

September 19, 2020

Study Completion (ACTUAL)

September 19, 2020

Study Registration Dates

First Submitted

July 22, 2020

First Submitted That Met QC Criteria

July 27, 2020

First Posted (ACTUAL)

July 28, 2020

Study Record Updates

Last Update Posted (ACTUAL)

October 23, 2020

Last Update Submitted That Met QC Criteria

October 22, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • Project 0470-Pilot study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Main Focus: Gluten and Starch Digestibility

Clinical Trials on Glutalytic®

3
Subscribe