Main Focus: Gluten and Starch DigestibilityGlutDigestNCT04489810
Digestion of Gluten in the Presence of Enzymes
A study testing Elevase®, DE111® and Meal A in people with Main Focus: Gluten and Starch Digestibility, run by The Archer-Daniels-Midland Company at 1 site in Ireland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Main Focus: Gluten and Starch Digestibility
- What is being tested?
- Elevase®, DE111® and Meal A
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- 1 siteIreland
- Study dates
- 19 Oct 2020to 8 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: GlutDigest - Enzymes-assisted Gluten Digestion
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.
Read the detailed description
RATIONALE 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.
Elevase®, is a dietary supplement based on an enzyme preparation which effectively degrades gluten in vitro (Healey, Hall et al. unpublished). As it has also been found that the rate of wheat protein digestion can be increased in the presence of amylases (Smith, Pan et al. 2015), Elevase® is also enriched with amylase to aid in starch digestion.
The structural properties of food are influenced by numerous factors including meal preparation practices. Two common practices that can influence nutrient availability differently are heating vs. refrigerating (e.g. oat porridge vs. soaked and refrigerated oats).
Bacillus subtilis DE111® can produce and secrete many enzymes, including proteases, which, if secreted into the environment of the digestive tract, could support digestion and, in particular, the digestion of gluten. However, it is not clear whether diet supplementation with DE111 is a physiologically viable approach in terms of probiotic survival in the gastrointestinal tract.
PURPOSE The aims of this study are to better understand the impact of each of these factors and whether supplementation with probiotic spores is a viable option.
- Being tested
- Placebo, Elevase®, DE111®, Meal A, Meal B
- Keywords
- Gluten, Starch, Digestive enzymes, Probiotics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
Maltodextrin capsule manufactured to mimic the Elevase® and DE111® capsules
Elevase®Dietary supplement
1 capsule containing 350 mg of Elevase®
DE111®Dietary supplement
1 capsule containing Bacillus subtilis DE111
Meal AOther
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 BOther
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
| Study group | Role | What they receive |
|---|---|---|
| Meal A + Placebo | Placebo comparator | 350 mg Placebo capsule, taken by mouth, once, with Meal A Receives: Dietary Supplement: Placebo; Other: Meal A |
| Meal A + Elevase® | Experimental | 350 mg Elevase® capsule, taken by mouth, once, with Meal A Receives: Dietary Supplement: Elevase®; Other: Meal A |
| Meal A + DE111® | Experimental | 350 mg DE111® capsule, taken by mouth, once, with Meal A Receives: Dietary Supplement: DE111®; Other: Meal A |
| Meal B + Placebo | Experimental | 350 mg Placebo capsule, taken by mouth, once, with Meal B Receives: Dietary Supplement: Placebo; Other: Meal B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Undigested wheat protein
Difference between the mean concentration of undigested wheat protein in ileal effluent samples.
Measured: 9-hour period after the test meal
Secondary outcomes (4)
Vegetative DE111 cells
Mean concentration of DE111® cells recovered in the ileal effluent in the vegetative state.
Measured: 9-hour period after the test meal
Glycemic response
Difference between the mean area under the glucose concentration (measured in the interstitial fluid) curves following each treatment
Measured: At baseline, and at different time-points during 9 hours after after consuming the test meal.
Undigested starch
Difference between the mean concentration of undigested starch in ileal effluent samples.
Measured: At baseline and once every hour in the 9-hour period after consumption of the test meal.
Undigested food particles
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.
Measured: 9-hour period after the test meal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2020
- Study start19 Oct 2020
- Primary completion8 Apr 2021
- Study completion8 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Main Focus: Gluten and Starch DigestibilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Archer-Daniels-Midland Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Teagasc, Atlantia Food Clinical Trials
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04489810
- Sponsor's protocol ID
- Project 0470
- Acronym
- GlutDigest
- Status last verified
- May 2024
- First submitted
- 22 Jul 2020
- Last updated
- 10 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26202208
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GlutDigest - Enzymes-assisted Gluten Digestion
- ClinicalTrials.gov ID
- NCT04489810
- Acronym / sponsor ID
- GlutDigest / Project 0470
- Keywords
- Gluten, Starch, Digestive enzymes, Probiotics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- The Archer-Daniels-Midland CompanyIndustry (pharma, biotech, devices)
- Collaborators
- Teagasc, Atlantia Food Clinical Trials
- Study start
- 19 Oct 2020 (actual)
- Primary completion
- 8 Apr 2021 (actual)
- Study completion
- 8 Apr 2021 (actual)
- First posted
- 28 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
RATIONALE 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.
Elevase®, is a dietary supplement based on an enzyme preparation which effectively degrades gluten in vitro (Healey, Hall et al. unpublished). As it has also been found that the rate of wheat protein digestion can be increased in the presence of amylases (Smith, Pan et al. 2015), Elevase® is also enriched with amylase to aid in starch digestion.
The structural properties of food are influenced by numerous factors including meal preparation practices. Two common practices that can influence nutrient availability differently are heating vs. refrigerating (e.g. oat porridge vs. soaked and refrigerated oats).
Bacillus subtilis DE111® can produce and secrete many enzymes, including proteases, which, if secreted into the environment of the digestive tract, could support digestion and, in particular, the digestion of gluten. However, it is not clear whether diet supplementation with DE111 is a physiologically viable approach in terms of probiotic survival in the gastrointestinal tract.
PURPOSE The aims of this study are to better understand the impact of each of these factors and whether supplementation with probiotic spores is a viable option.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Meal A + Placebo | Placebo comparator | Dietary Supplement: Placebo, Other: Meal A350 mg Placebo capsule, taken by mouth, once, with Meal A |
| Meal A + Elevase® | Experimental | Dietary Supplement: Elevase®, Other: Meal A350 mg Elevase® capsule, taken by mouth, once, with Meal A |
| Meal A + DE111® | Experimental | Dietary Supplement: DE111®, Other: Meal A350 mg DE111® capsule, taken by mouth, once, with Meal A |
| Meal B + Placebo | Experimental | Dietary Supplement: Placebo, Other: Meal B350 mg Placebo capsule, taken by mouth, once, with Meal B |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboMaltodextrin capsule manufactured to mimic the Elevase® and DE111® capsules | Dietary supplement | Meal A + Placebo, Meal B + Placebo |
| Elevase®1 capsule containing 350 mg of Elevase® | Dietary supplement | Meal A + Elevase® |
| DE111®1 capsule containing Bacillus subtilis DE111 | Dietary supplement | Meal A + DE111® |
| Meal AOatmeal 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 A + DE111®, Meal A + Elevase®, Meal A + Placebo |
| Meal BRefrigerated oatmeal - serving of refrigerated oats containing 50g of carbohydrates (excluding sugars); Wheat cereal - serving of wheat cereal providing 1g of gluten; Water - 125 mL | Other | Meal B + Placebo |
Primary outcome
Undigested wheat protein
Time frame: 9-hour period after the test meal
Difference between the mean concentration of undigested wheat protein in ileal effluent samples.
4 secondary outcomes
Vegetative DE111 cells
Time frame: 9-hour period after the test meal
Glycemic response
Time frame: At baseline, and at different time-points during 9 hours after after consuming the test meal.
Undigested starch
Time frame: At baseline and once every hour in the 9-hour period after consumption of the test meal.
Undigested food particles
Time frame: 9-hour period after the test meal
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2025.
- Background: PubMed 26202208Smith 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Elevase®, DE111® and Meal A in people with Main Focus: Gluten and Starch Digestibility, run by The Archer-Daniels-Midland Company at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Undigested wheat protein (time frame: 9-hour period after the test meal). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04489810, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2025; AzTrials last refreshed its copy on 8 Nov 2026.