Effect of AN-PEP Enzyme on Gluten Digestion

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.

Study Overview

• Status: Completed
• Conditions: Gluten Digestion
• Intervention / Treatment: Dietary supplement: AN-PEP

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 Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Maastricht, Netherlands
    • Maastricht University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: AN-PEP with low caloric meal	Dietary supplement: AN-PEP; Endoprotease enzyme (AN-PEP); Other Names: Aspergillus Niger Prolyl EndoProtease enzyme (AN-PEP)
Active Comparator: AN-PEP with high caloric meal	Dietary supplement: AN-PEP; Endoprotease enzyme (AN-PEP); Other Names: Aspergillus Niger Prolyl EndoProtease enzyme (AN-PEP)
Placebo Comparator: Placebo with low caloric meal	Dietary supplement: AN-PEP; Endoprotease enzyme (AN-PEP); Other Names: Aspergillus Niger Prolyl EndoProtease enzyme (AN-PEP)
Placebo Comparator: Placebo with high caloric meal	Dietary supplement: AN-PEP; Endoprotease enzyme (AN-PEP); Other Names: Aspergillus Niger Prolyl EndoProtease enzyme (AN-PEP)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: DSM Food Specialties
• Investigators: Principal Investigator: Ad Masclee, Prof Dr, Maastricht University Medical Center

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (Actual): May 1, 2012
• Study Completion (Actual): May 1, 2012

Study Registration Dates

• First Submitted: April 12, 2011
• First Submitted That Met QC Criteria: April 13, 2011
• First Posted (Estimate): April 14, 2011

Study Record Updates

• Last Update Posted (Estimate): August 13, 2013
• Last Update Submitted That Met QC Criteria: August 12, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Keywords: gluten
• Other Study ID Numbers: AN-PEP-02