Effect of AN-PEP Enzyme on Gluten Digestion

Gluten Digestion Clinical Trial

Official title:

Effect of AN-PEP Enzyme on Gastrointestinal Breakdown of Gluten

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01335503
• Other study ID #: AN-PEP-02
• Status: Completed
• Phase: N/A
• First received: April 12, 2011
• Last updated: August 12, 2013
• Start date: April 2011
• Est. completion date: May 2012

Study information

• Verified date: August 2013
• Source: DSM Food Specialties
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 44 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gluten Digestion

Intervention

Dietary Supplement:
• AN-PEP
Endoprotease enzyme (AN-PEP)

Locations

Country	Name	City	State
Netherlands	Maastricht University	Maastricht

Sponsors (1)

Lead Sponsor	Collaborator
DSM Food Specialties

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of AN-PEP with a low or high caloric meal on gluten degradation in the duodenum	Difference in gluten (volume x concentration) x time between AN-PEP and placebo with a low or high caloric meal in the duodenum	0-240 min	No
Secondary	Effect of AN-PEP with a low or high caloric meal on gluten degradation in the stomach	Difference in gluten concentration x time between AN-PEP and placebo with a low or high caloric meal in the stomach	0-240 min	No
Secondary	Effect of meal caloric density on gastric emptying	Difference in gastric half emptying time by 13CO2:12CO2 in breath between the high and low caloric meals	0-240 min	No
Secondary	Effect of AN-PEP and meal caloric density on gastric and duodenal pH	Change in gastric and duodenal pH over time	0-240 min	No
Secondary	Effect of caloric density on AN-PEP-mediated gluten degradation in the duodenum	Difference in gluten (concentration) x time between AN-PEP with a high vs low caloric meal in the duodenum	0-240 min	No
Secondary	Effect of caloric density on AN-PEP-mediated gluten degradation in the stomach	Difference in gluten concentration x time between AN-PEP with a high vs low caloric meal in the stomach	0-240 min	No