Effect of AN-PEP Enzyme on Gluten Digestion

Not Applicable

Completed

• Conditions: Gluten Digestion
• Interventions: Dietary Supplement: AN-PEP

• Registration Number: NCT01335503
• Lead Sponsor: DSM Food Specialties

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.

Study Timeline

• Study Start: 2011-04
• Study First Submitted: 2011-04-12
• Study First Submitted QC: 2011-04-13
• Study First Posted: 2011-04-14
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-12
• Last Update Posted: 2013-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
AN-PEP with low caloric meal	AN-PEP	-
AN-PEP with high caloric meal	AN-PEP	-
Placebo with low caloric meal	AN-PEP	-
Placebo with high caloric meal	AN-PEP	-

Primary Outcome Measures

Name	Time	Method
Effect of AN-PEP with a low or high caloric meal on gluten degradation in the duodenum	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

Secondary Outcome Measures

Name	Time	Method
Effect of AN-PEP with a low or high caloric meal on gluten degradation in the stomach	0-240 min	Difference in gluten concentration x time between AN-PEP and placebo with a low or high caloric meal in the stomach
Effect of meal caloric density on gastric emptying	0-240 min	Difference in gastric half emptying time by 13CO2:12CO2 in breath between the high and low caloric meals
Effect of AN-PEP and meal caloric density on gastric and duodenal pH	0-240 min	Change in gastric and duodenal pH over time
Effect of caloric density on AN-PEP-mediated gluten degradation in the duodenum	0-240 min	Difference in gluten (concentration) x time between AN-PEP with a high vs low caloric meal in the duodenum
Effect of caloric density on AN-PEP-mediated gluten degradation in the stomach	0-240 min	Difference in gluten concentration x time between AN-PEP with a high vs low caloric meal in the stomach

Trial Locations

Locations (1)

Maastricht University; 🇳🇱 Maastricht, Netherlands