Gluten DigestionNCT01335503
Effect of AN-PEP Enzyme on Gluten Digestion
A study testing AN-PEP in people with Gluten Digestion, run by DSM Food Specialties at 1 site in Netherlands.
Trial summary
The aim is to demonstrate how fast and to what extent AN-PEP can degrade gluten in vivo in the stomach and how much gluten enters the small intestine. A second question is whether the caloric density of a meal can influence the efficacy of AN-PEP breakdown. Read more about this study
- Who is it for?
- Ages 18 to 44 yearsHealthy volunteers can take part
- Conditions the study is for
- Gluten Digestion
- What is being tested?
- AN-PEP
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteNetherlands
- Study dates
- Apr 2011to May 2012
- 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 44 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male/female
- Age ≥ 18 years but < 45 years
- Hormonal contraceptive treatment
- Subject has read and understood the information provided on the study and given written informed consent
Who cannot join
- Any medical condition or laboratory test result that in the opinion of the investigators may interfere with the study and may jeopardise the health status of the participant
- pregnancy or lactation
- women not treated with hormonal contraceptive treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of AN-PEP Enzyme on Gastrointestinal Breakdown of Gluten
The aim is to demonstrate how fast and to what extent AN-PEP can degrade gluten in vivo in the stomach and how much gluten enters the small intestine. A second question is whether the caloric density of a meal can influence the efficacy of AN-PEP breakdown.
Read the detailed description
In this trial, the effect of AN-PEP enzyme on gastrointestinal breakdown of gluten will be investigated in healthy subjects. In addition, it will be assessed if meal calories can affect the efficacy of AN-PEP. Subjects receive intragastrically, either AN-PEP or placebo, with either a high or a low caloric meal in a double-blind, randomized, placebo-controlled, cross-over fashion. Gastrointestinal fluid will be sampled to measure breakdown of gluten.
- Conditions
- Gluten Digestion
- Being tested
- AN-PEP
- Keywords
- gluten
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AN-PEPDietary supplement
Also called Aspergillus Niger Prolyl EndoProtease enzyme (AN-PEP)
Endoprotease enzyme (AN-PEP)
| Study group | Role | What they receive |
|---|---|---|
| AN-PEP with low caloric meal | Active comparator | Not described Receives: Dietary Supplement: AN-PEP |
| AN-PEP with high caloric meal | Active comparator | Not described Receives: Dietary Supplement: AN-PEP |
| Placebo with low caloric meal | Placebo comparator | Not described Receives: Dietary Supplement: AN-PEP |
| Placebo with high caloric meal | Placebo comparator | Not described Receives: Dietary Supplement: AN-PEP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of AN-PEP with a low or high caloric meal on gluten degradation in the duodenum
Difference in gluten (volume x concentration) x time between AN-PEP and placebo with a low or high caloric meal in the duodenum
Measured: 0-240 min
Secondary outcomes (5)
Effect of AN-PEP with a low or high caloric meal on gluten degradation in the stomach
Difference in gluten concentration x time between AN-PEP and placebo with a low or high caloric meal in the stomach
Measured: 0-240 min
Effect of meal caloric density on gastric emptying
Difference in gastric half emptying time by 13CO2:12CO2 in breath between the high and low caloric meals
Measured: 0-240 min
Effect of AN-PEP and meal caloric density on gastric and duodenal pH
Change in gastric and duodenal pH over time
Measured: 0-240 min
Effect of caloric density on AN-PEP-mediated gluten degradation in the duodenum
Difference in gluten (concentration) x time between AN-PEP with a high vs low caloric meal in the duodenum
Measured: 0-240 min
Effect of caloric density on AN-PEP-mediated gluten degradation in the stomach
Difference in gluten concentration x time between AN-PEP with a high vs low caloric meal in the stomach
Measured: 0-240 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2011 (estimated)
- Study startApr 2011
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Gluten DigestionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- DSM Food Specialties
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ad Masclee, Prof Dr, Principal investigator, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01335503
- Sponsor's protocol ID
- AN-PEP-02
- Status last verified
- Aug 2013
- First submitted
- 12 Apr 2011
- Last updated
- 13 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Bartholome R, Salden B, Vrolijk MF, Troost FJ, Masclee A, Bast A, Haenen GR. Paracetamol as a Post Prandial Marker for Gastric Emptying, A Food-Drug Interaction on Absorption. PLoS One. 2015 Sep 9;10(9):e0136618. doi: 10.1371/journal.pone.0136618. eCollection 2015.
PubMed 26352940Salden BN, Monserrat V, Troost FJ, Bruins MJ, Edens L, Bartholome R, Haenen GR, Winkens B, Koning F, Masclee AA. Randomised clinical study: Aspergillus niger-derived enzyme digests gluten in the stomach of healthy volunteers. Aliment Pharmacol Ther. 2015 Aug;42(3):273-85. doi: 10.1111/apt.13266. Epub 2015 Jun 4.
PubMed 26040627
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of AN-PEP Enzyme on Gastrointestinal Breakdown of Gluten
- ClinicalTrials.gov ID
- NCT01335503
- Acronym / sponsor ID
- AN-PEP-02
- Conditions
- Gluten Digestion
- Keywords
- gluten
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- DSM Food SpecialtiesIndustry (pharma, biotech, devices)
- Study start
- Apr 2011
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 14 Apr 2011 (estimated)
- 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.
The aim is to demonstrate how fast and to what extent AN-PEP can degrade gluten in vivo in the stomach and how much gluten enters the small intestine. A second question is whether the caloric density of a meal can influence the efficacy of AN-PEP breakdown.
Detailed description
In this trial, the effect of AN-PEP enzyme on gastrointestinal breakdown of gluten will be investigated in healthy subjects. In addition, it will be assessed if meal calories can affect the efficacy of AN-PEP. Subjects receive intragastrically, either AN-PEP or placebo, with either a high or a low caloric meal in a double-blind, randomized, placebo-controlled, cross-over fashion. Gastrointestinal fluid will be sampled to measure breakdown of gluten.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| AN-PEP with low caloric meal | Active comparator | Dietary Supplement: AN-PEP |
| AN-PEP with high caloric meal | Active comparator | Dietary Supplement: AN-PEP |
| Placebo with low caloric meal | Placebo comparator | Dietary Supplement: AN-PEP |
| Placebo with high caloric meal | Placebo comparator | Dietary Supplement: AN-PEP |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male/female
- Age ≥ 18 years but < 45 years
- Hormonal contraceptive treatment
- Subject has read and understood the information provided on the study and given written informed consent
Key exclusion criteria (3 listed)
- Any medical condition or laboratory test result that in the opinion of the investigators may interfere with the study and may jeopardise the health status of the participant
- pregnancy or lactation
- women not treated with hormonal contraceptive treatment
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 |
|---|---|---|
| AN-PEPAlso: Aspergillus Niger Prolyl EndoProtease enzyme (AN-PEP)Endoprotease enzyme (AN-PEP) | Dietary supplement | AN-PEP with high caloric meal, AN-PEP with low caloric meal, Placebo with high caloric meal, Placebo with low caloric meal |
Primary outcome
Effect of AN-PEP with a low or high caloric meal on gluten degradation in the duodenum
Time frame: 0-240 min
Difference in gluten (volume x concentration) x time between AN-PEP and placebo with a low or high caloric meal in the duodenum
5 secondary outcomes
Effect of AN-PEP with a low or high caloric meal on gluten degradation in the stomach
Time frame: 0-240 min
Effect of meal caloric density on gastric emptying
Time frame: 0-240 min
Effect of AN-PEP and meal caloric density on gastric and duodenal pH
Time frame: 0-240 min
Effect of caloric density on AN-PEP-mediated gluten degradation in the duodenum
Time frame: 0-240 min
Effect of caloric density on AN-PEP-mediated gluten degradation in the stomach
Time frame: 0-240 min
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 13 Aug 2013.
- Derived from this study: PubMed 26352940Bartholome R, Salden B, Vrolijk MF, Troost FJ, Masclee A, Bast A, Haenen GR. Paracetamol as a Post Prandial Marker for Gastric Emptying, A Food-Drug Interaction on Absorption. PLoS One. 2015 Sep 9;10(9):e0136618. doi: 10.1371/journal.pone.0136618. eCollection 2015.
- Derived from this study: PubMed 26040627Salden BN, Monserrat V, Troost FJ, Bruins MJ, Edens L, Bartholome R, Haenen GR, Winkens B, Koning F, Masclee AA. Randomised clinical study: Aspergillus niger-derived enzyme digests gluten in the stomach of healthy volunteers. Aliment Pharmacol Ther. 2015 Aug;42(3):273-85. doi: 10.1111/apt.13266. Epub 2015 Jun 4.
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.
Ad Masclee, Prof Dr principal investigator
Maastricht University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AN-PEP in people with Gluten Digestion, run by DSM Food Specialties at 1 site in Netherlands.
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 3 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 13 Aug 2013. 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 Netherlands. 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?
Effect of AN-PEP with a low or high caloric meal on gluten degradation in the duodenum (time frame: 0-240 min). 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 NCT01335503, which also lists 2 linked publications.
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 13 Aug 2013; AzTrials last refreshed its copy on 7 Nov 2026.