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Effect of AN-PEP enzyme on gluten digestion.


- candidate number9170
- NTR NumberNTR2780
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR2-mrt-2011
- Secondary IDs 
- Public TitleEffect of AN-PEP enzyme on gluten digestion.
- Scientific TitleEffect of AN-PEP enzyme on gastrointestinal breakdown of gluten in healthy subjects.
- ACRONYMAN-PEP-02
- hypothesisAN-PEP helps to digest gluten in vivo.
- Healt Condition(s) or Problem(s) studiedGluten, Healthy subjects
- Inclusion criteria1. Male/female;
2. Age ≥18 but <45 yr;
3. Hormonal contraceptive treatment;
4. Subject is willing to undergo all protocol related assessments;
5. Subject has read and understood the information provided on the study and given written informed consent.
- Exclusion criteriaAny 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.
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 30-apr-2011
- planned closingdate15-okt-2011
- Target number of participants12
- InterventionsAll subjects will come to the study site for 4 test days. A gastro-duodenal catheter will be placed in the stomach and duodenum under x-ray control.
At these test days, in a crossover fashion, all subjects receive enterally via this catheter one of the following treatments:
1. A low caloric gluten meal together with AN-PEP drink;
2. A high caloric gluten meal together with AN-PEP drink;
3. A low caloric gluten meal together with placebo drink;
4. A high caloric gluten meal together with placebo drink.
The subjects will be randomised before start in a double-blind fashion in blocks of four. Meals contain 5.2 g gluten powder (4 g gluten protein) which is mixed in all test meals (300 mL). The low and high caloric meals differ in fat and carbohydrate. The meal is co-infused with AN-PEP or placebo in 50 mL water. Stable 13C-octanoic acid is added to the meals to measure gastric emptying rate.
- Primary outcomeEffect AN-PEP with a low or high caloric meal on duodenal gluten epitope exposure.
- Secondary outcomeEffect AN-PEP with a low or high caloric meal on:
1. Gastric gluten concentrations and AUC over time;
2. Gastric and duodenal pH;
3. Gastric half emptying time;
4. Gastric and duodenal gluten concentrations or absolute amounts over time related to 3 and 4.

Difference in means between a low and high caloric meal with AN-PEP in:
1. All endpoints mentioned above.
- TimepointsN/A
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESProf. Dr. Ad Masclee
- CONTACT for SCIENTIFIC QUERIESDr. Freddy J. Troost
- Sponsor/Initiator DSM
- Funding
(Source(s) of Monetary or Material Support)
DSM
- PublicationsN/A
- Brief summaryIn 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.
- Main changes (audit trail)
- RECORD2-mrt-2011 - 8-mrt-2011


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