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

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Ireland
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Meal A + Glutalytic®
350 mg Glutalytic® capsule, taken by mouth, once, with Meal A
Dietary supplement: Glutalytic®
Glutalytic® 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
EXPERIMENTAL: Meal A + DE111®
350 mg DE111® capsule, taken by mouth, once, with Meal A
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
Dietary supplement: DE111®
DE111® capsule

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Deerland Enzymes

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Atlantia Food Clinical Trials
Teagasc

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 31, 2020

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 19, 2020

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 19, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 22, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 27, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 28, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 23, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 22, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings