Effect of AN-PEP Enzyme on Gluten Digestion

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effect of AN-PEP Enzyme on Gastrointestinal Breakdown of Gluten

Conditions
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Gluten Digestion

Intervention / Treatment
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* Dietary Supplement: AN-PEP


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 44 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: AN-PEP with low caloric meal<br> | Dietary Supplement: AN-PEP<br>* Endoprotease enzyme (AN-PEP)<br>* Other names: Aspergillus Niger Prolyl EndoProtease enzyme (AN-PEP);|
| Active Comparator: AN-PEP with high caloric meal<br> | Dietary Supplement: AN-PEP<br>* Endoprotease enzyme (AN-PEP)<br>* Other names: Aspergillus Niger Prolyl EndoProtease enzyme (AN-PEP);|
| Placebo Comparator: Placebo with low caloric meal<br> | Dietary Supplement: AN-PEP<br>* Endoprotease enzyme (AN-PEP)<br>* Other names: Aspergillus Niger Prolyl EndoProtease enzyme (AN-PEP);|
| Placebo Comparator: Placebo with high caloric meal<br> | Dietary Supplement: AN-PEP<br>* Endoprotease enzyme (AN-PEP)<br>* Other names: Aspergillus Niger Prolyl EndoProtease enzyme (AN-PEP);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gluten