Effect of AN-PEP Enzyme on Gluten Digestion

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2012-05-31

Brief Summary

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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.

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Detailed Description

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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

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Gluten Digestion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Endoprotease enzyme (AN-PEP)

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Aspergillus Niger Prolyl EndoProtease enzyme (AN-PEP)

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

44 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes