Clinical trial NCT01335503: Effect of AN-PEP Enzyme on Gluten Digestion
Official title: Effect of AN-PEP Enzyme on Gastrointestinal Breakdown of Gluten
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gluten Digestion
Keywords: gluten
Lead sponsor: DSM Food Specialties
Sponsor class: INDUSTRY
First posted: 2011-04-14
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Effect of AN-PEP with a low or high caloric meal on gluten degradation in the duodenum
timeFrame: 0-240 min
Secondary outcomes:
measure: Effect of AN-PEP with a low or high caloric meal on gluten degradation in the stomach
timeFrame: 0-240 min
measure: Effect of meal caloric density on gastric emptying
timeFrame: 0-240 min
measure: Effect of AN-PEP and meal caloric density on gastric and duodenal pH
timeFrame: 0-240 min
measure: Effect of caloric density on AN-PEP-mediated gluten degradation in the duodenum
timeFrame: 0-240 min
measure: Effect of caloric density on AN-PEP-mediated gluten degradation in the stomach
timeFrame: 0-240 min
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University
Study officials:
affiliation: Maastricht University Medical Center
name: Ad Masclee, Prof Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Salden 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.