NCT01335503

Effect of AN-PEP Enzyme on Gluten Digestion

Effect of AN-PEP Enzyme on Gastrointestinal Breakdown of Gluten

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: DSM Food Specialties · Industry
• Sex: All
• Age: 18 Years – 44 Years
• Healthy volunteers: Accepted

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.

Conditions

• Gluten Digestion

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	AN-PEP	Endoprotease enzyme (AN-PEP)

Timeline

• Start date: 2011-04-01
• Primary completion: 2012-05-01
• Completion: 2012-05-01
• First posted: 2011-04-14
• Last updated: 2013-08-13

Locations

1 site across 1 country: Netherlands