Gluten Digestion
Conditions
Keywords
gluten
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.
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.
Interventions
DIETARY_SUPPLEMENTAN-PEP
Endoprotease enzyme (AN-PEP)
Sponsors
DSM Food Specialties
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 44 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effect of AN-PEP with a low or high caloric meal on gluten degradation in the duodenum | 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
| Measure | Time frame | Description |
|---|---|---|
| Effect of AN-PEP with a low or high caloric meal on gluten degradation in the stomach | 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 | 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 | 0-240 min | Change in gastric and duodenal pH over time |
| Effect of caloric density on AN-PEP-mediated gluten degradation in the duodenum | 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 | 0-240 min | Difference in gluten concentration x time between AN-PEP with a high vs low caloric meal in the stomach |
Countries
Netherlands
Outcome results
None listed