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Effect of AN-PEP Enzyme on Gluten Digestion

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by DSM Food Specialties.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
DSM Food Specialties
ClinicalTrials.gov Identifier:
NCT01335503
First received: April 12, 2011
Last updated: April 13, 2011
Last verified: April 2011
History of Changes
  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
Celiac Disease
 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

Resource links provided by NLM:

MedlinePlus related topics: Celiac Disease
U.S. FDA Resources

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


Estimated Enrollment: 12
Study Start Date: April 2011
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: November 2011 (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

Contacts
Contact: Freddy J Troost, Dr +31 43-3884296 f.troost@maastrichtuniversity.nl
Contact: Ad Masclee, Prof Dr +31 43 3875021 a.masclee@mumc.nl

Locations
Netherlands
Maastricht University Not yet recruiting
Maastricht, Netherlands
Contact: Freddy J Troost, Dr     +31 43-3884296     f.troost@maastrichtuniversity.nl    
Principal Investigator: Ad Masclee, Prof Dr            
Sponsors and Collaborators
DSM Food Specialties
Investigators
Principal Investigator: Ad Masclee, Prof Dr Maastricht University Medical Center
  More Information

No publications provided

Responsible Party: Dr F Troost, Maastricht University, Maastricht, The Netherlands
ClinicalTrials.gov Identifier: NCT01335503     History of Changes
Other Study ID Numbers: AN-PEP-02
Study First Received: April 12, 2011
Last Updated: April 13, 2011
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by DSM Food Specialties:
gluten

Additional relevant MeSH terms:
Celiac Disease
Malabsorption Syndromes
Intestinal Diseases
 Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases

ClinicalTrials.gov processed this record on June 18, 2013