Completed

NCT Number: NCT01335503

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.

Completed

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Key information

Conditions

Gluten Digestion

Age range

18 year–44 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maastricht University

Maastricht, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AN-PEP

Dietary Supplement

Endoprotease enzyme (AN-PEP)

Other names: Aspergillus Niger Prolyl EndoProtease enzyme (AN-PEP)

Primary outcomes

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

Time frame: 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 outcomes

Effect of AN-PEP with a low or high caloric meal on gluten degradation in the stomach

Time frame: 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

Time frame: 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

Time frame: 0-240 min

Change in gastric and duodenal pH over time
Effect of caloric density on AN-PEP-mediated gluten degradation in the duodenum

Time frame: 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

Time frame: 0-240 min

Difference in gluten concentration x time between AN-PEP with a high vs low caloric meal in the stomach

Sponsors and collaborators

Lead sponsor

DSM Food Specialties

Industry

Registry information

Official study title

Effect of AN-PEP Enzyme on Gastrointestinal Breakdown of Gluten

Important dates

Study start: 2011
Primary completion: 2012
Study completion: 2012
First posted: Apr 14, 2011
Registry last updated: Aug 13, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.