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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AN-PEP with low caloric meal | Active Comparator |
| |
| AN-PEP with high caloric meal | Active Comparator |
| |
| Placebo with low caloric meal | Placebo Comparator |
| |
| Placebo with high caloric meal | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AN-PEP | Dietary Supplement | Endoprotease enzyme (AN-PEP) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 0-240 min |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 0-240 min |
| Effect of meal caloric density on gastric emptying |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ad Masclee, Prof Dr | Maastricht University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maastricht University | Maastricht | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26352940 | Derived | 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. | |
| 26040627 | Derived | 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. |
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|
Difference in gastric half emptying time by 13CO2:12CO2 in breath between the high and low caloric meals |
| 0-240 min |
| Effect of AN-PEP and meal caloric density on gastric and duodenal pH | Change in gastric and duodenal pH over time | 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 | 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 | 0-240 min |