Effect of AN-PEP Enzyme on Gluten Digestion
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ClinicalTrials.gov Identifier: NCT01335503 |
Recruitment Status
:
Completed
First Posted
: April 14, 2011
Last Update Posted
: August 13, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Gluten Digestion | Dietary Supplement: AN-PEP | Not Applicable |
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 |
Actual Primary Completion Date : | May 2012 |
Actual Study Completion Date : | May 2012 |
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)
|
- 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
- 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
- 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
- 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
- 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
- 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

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Ages Eligible for Study: | 18 Years to 44 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

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
Netherlands | |
Maastricht University | |
Maastricht, Netherlands |
Principal Investigator: | Ad Masclee, Prof Dr | Maastricht University Medical Center |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | DSM Food Specialties |
ClinicalTrials.gov Identifier: | NCT01335503 History of Changes |
Other Study ID Numbers: |
AN-PEP-02 |
First Posted: | April 14, 2011 Key Record Dates |
Last Update Posted: | August 13, 2013 |
Last Verified: | August 2013 |
Keywords provided by DSM Food Specialties:
gluten |