Effect of AN-PEP Enzyme on Gluten Digestion

Launched by DSM FOOD SPECIALTIES · Apr 13, 2011

Keywords

ClinConnect Summary

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.

Gender

ALL

Eligibility criteria

• 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