Effect of AN-PEP Enzyme on Gluten Digestion

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
DSM Food Specialties
ClinicalTrials.gov Identifier:
NCT01335503
First received: April 12, 2011
Last updated: August 12, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention
Gluten Digestion
Dietary Supplement: AN-PEP

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of AN-PEP Enzyme on Gastrointestinal Breakdown of Gluten

Further study details as provided by DSM Food Specialties:

Primary Outcome Measures:
  • Effect of AN-PEP with a low or high caloric meal on gluten degradation in the duodenum [ Time Frame: 0-240 min ] [ Designated as safety issue: No ]
    Difference in gluten (volume x concentration) x time between AN-PEP and placebo with a low or high caloric meal in the duodenum


Secondary Outcome Measures:
  • Effect of AN-PEP with a low or high caloric meal on gluten degradation in the stomach [ Time Frame: 0-240 min ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Difference in gluten concentration x time between AN-PEP with a high vs low caloric meal in the stomach


Enrollment: 12
Study Start Date: April 2011
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: AN-PEP with low caloric meal Dietary Supplement: AN-PEP
Endoprotease enzyme (AN-PEP)
Other Name: Aspergillus Niger Prolyl EndoProtease enzyme (AN-PEP)
Active Comparator: AN-PEP with high caloric meal Dietary Supplement: AN-PEP
Endoprotease enzyme (AN-PEP)
Other Name: Aspergillus Niger Prolyl EndoProtease enzyme (AN-PEP)
Placebo Comparator: Placebo with low caloric meal Dietary Supplement: AN-PEP
Endoprotease enzyme (AN-PEP)
Other Name: Aspergillus Niger Prolyl EndoProtease enzyme (AN-PEP)
Placebo Comparator: Placebo with high caloric meal Dietary Supplement: AN-PEP
Endoprotease enzyme (AN-PEP)
Other Name: Aspergillus Niger Prolyl EndoProtease enzyme (AN-PEP)

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.

  Eligibility

Ages Eligible for Study:   18 Years to 44 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01335503

Locations
Netherlands
Maastricht University
Maastricht, Netherlands
Sponsors and Collaborators
DSM Food Specialties
Investigators
Principal Investigator: Ad Masclee, Prof Dr Maastricht University Medical Center
  More Information

No publications provided

Responsible Party: DSM Food Specialties
ClinicalTrials.gov Identifier: NCT01335503     History of Changes
Other Study ID Numbers: AN-PEP-02
Study First Received: April 12, 2011
Last Updated: August 12, 2013
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by DSM Food Specialties:
gluten

ClinicalTrials.gov processed this record on April 17, 2014