Main Focus: Gluten and Starch DigestibilityGlutDigestPNCT04489836
GlutDigest - Pilot Study
A study testing Glutalytic®, DE111® and Meal A in people with Main Focus: Gluten and Starch Digestibility, run by Deerland Enzymes at 1 site in Ireland.
Trial summary
This is a pilot, feasibility study to evaluate, test and optimize sample analysis procedures and protocols before the full-scale, crossover study is conducted. 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?
- Glutalytic®, DE111® and Meal A
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteIreland
- Study dates
- 31 Aug 2020to 19 Sep 2020
- 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 (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.
Read the 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.
- Being tested
- Glutalytic®, DE111®, Meal A
- 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.
Glutalytic®Dietary supplement
Glutalytic® capsule
DE111®Dietary supplement
DE111® capsule
Meal AOther
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
| Study group | Role | What they receive |
|---|---|---|
| Meal A + Glutalytic® | Experimental | 350 mg Glutalytic® capsule, taken by mouth, once, with Meal A Receives: Dietary Supplement: Glutalytic®; 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Undigested wheat protein after each treatment
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 samples.
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 in the 9-hour period after consumption of the test meal.
Undigested starch
Difference between the mean concentration of undigested starch in ileal effluent samples.
Measured: 9-hour period after 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 start31 Aug 2020
- Primary completion19 Sep 2020
- Study completion19 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Deerland Enzymes
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Teagasc, Atlantia Food Clinical Trials
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04489836
- Sponsor's protocol ID
- Project 0470-Pilot study
- Acronym
- GlutDigestP
- Status last verified
- Oct 2020
- First submitted
- 22 Jul 2020
- Last updated
- 23 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GlutDigest - Enzymes-assisted Gluten Digestion (Pilot Study)
- ClinicalTrials.gov ID
- NCT04489836
- Acronym / sponsor ID
- GlutDigestP / Project 0470-Pilot study
- Keywords
- Gluten, Starch, Digestive enzymes, Probiotics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Deerland EnzymesIndustry (pharma, biotech, devices)
- Collaborators
- Teagasc, Atlantia Food Clinical Trials
- Study start
- 31 Aug 2020 (actual)
- Primary completion
- 19 Sep 2020 (actual)
- Study completion
- 19 Sep 2020 (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 is a pilot, feasibility study to evaluate, test and optimize sample analysis procedures and protocols before the full-scale, crossover study is conducted.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Meal A + Glutalytic® | Experimental | Dietary Supplement: Glutalytic®, Other: Meal A350 mg Glutalytic® 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 |
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 |
|---|---|---|
| Glutalytic®Glutalytic® capsule | Dietary supplement | Meal A + Glutalytic® |
| DE111®DE111® capsule | Dietary supplement | Meal A + DE111® |
| Meal AOatmeal 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 | Other | Meal A + DE111®, Meal A + Glutalytic® |
Primary outcome
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.
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 in the 9-hour period after consumption of the test meal.
Undigested starch
Time frame: 9-hour period after 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 23 Oct 2020.
- 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 Glutalytic®, DE111® and Meal A in people with Main Focus: Gluten and Starch Digestibility, run by Deerland Enzymes 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 23 Oct 2020. 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. 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 after each treatment (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?
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 23 Oct 2020.