Effect of AN-PEP Enzyme on Gluten Digestion
Effect of AN-PEP Enzyme on Gluten Digestion
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.
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