We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu
IMPORTANT: Due to the lapse in government funding, the information on this web site may not be up to date, transactions submitted via the web site may not be processed, and the agency may not be able to respond to inquiries until appropriations are enacted. Updates regarding government operating status and resumption of normal operations can be found at opm.gov.

Effect of AN-PEP Enzyme on Gluten Digestion

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01335503
Recruitment Status : Completed
First Posted : April 14, 2011
Last Update Posted : August 13, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Gluten Digestion Dietary Supplement: 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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of AN-PEP Enzyme on Gastrointestinal Breakdown of Gluten
Study Start Date : April 2011
Primary Completion Date : May 2012
Study Completion Date : May 2012
Arms and Interventions

Arm Intervention/treatment
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)


Outcome Measures

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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


Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 44 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01335503


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