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Note: This record shows only 21 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 February 2015
Main ID:  NCT01335503
Date of registration: 12/04/2011
Prospective Registration: Yes
Primary sponsor: DSM Food Specialties
Public title: Effect of AN-PEP Enzyme on Gluten Digestion
Scientific title: Effect of AN-PEP Enzyme on Gastrointestinal Breakdown of Gluten
Date of first enrolment: April 2011
Target sample size: 12
Recruitment status: Completed
URL:  http://clinicaltrials.gov/show/NCT01335503
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  
Phase:  N/A
Countries of recruitment
Netherlands
Contacts
Name:     Ad Masclee, Prof Dr
Address: 
Telephone:
Email:
Affiliation:  Maastricht University Medical Center
Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 44 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Gluten Digestion
Intervention(s)
Dietary Supplement: AN-PEP
Primary Outcome(s)
Effect of AN-PEP with a low or high caloric meal on gluten degradation in the duodenum [Time Frame: 0-240 min]
Secondary Outcome(s)
Effect of AN-PEP and meal caloric density on gastric and duodenal pH [Time Frame: 0-240 min]
Effect of AN-PEP with a low or high caloric meal on gluten degradation in the stomach [Time Frame: 0-240 min]
Effect of caloric density on AN-PEP-mediated gluten degradation in the duodenum [Time Frame: 0-240 min]
Effect of caloric density on AN-PEP-mediated gluten degradation in the stomach [Time Frame: 0-240 min]
Effect of meal caloric density on gastric emptying [Time Frame: 0-240 min]
Secondary ID(s)
AN-PEP-02
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Results
Results available:
Date Posted:
URL:
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