Trials / Completed
CompletedNCT02060864
Effect of AN-PEP Enzyme on Gluten Digestion in Gluten Sensitive Individuals
Effect of the Enzyme AN-PEP on Gluten Degradation in the Stomach of Gluten-sensitive Individuals
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 18 (actual)
- Sponsor
- DSM Food Specialties · Industry
- Sex
- All
- Age
- 18 Years – 69 Years
- Healthy volunteers
- Accepted
Summary
In this trial, the effect of a low and a high dose AN-PEP will be investigated in gluten sensitive individuals. Volunteers receive a breakfast with background (0.5 g) gluten. Capsules are taken in the morning within 5 min after start of breakfast. Gastrointestinal fluid will be sampled over 3 hours to measure gluten degradation. After 5 volunteers have completed 3 test days, a blind interim analysis is performed by a third party based on which it is decided whether to proceed with the low AN-PEP dose.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | AN-PEP | Two pills are consumed in the morning with a breakfast |
| DIETARY_SUPPLEMENT | Placebo |
Timeline
- Start date
- 2014-04-01
- Primary completion
- 2015-08-01
- Completion
- 2015-08-01
- First posted
- 2014-02-12
- Last updated
- 2015-08-28
Locations
1 site across 1 country: Sweden
Source: ClinicalTrials.gov record NCT02060864. Inclusion in this directory is not an endorsement.