Effect of AN-PEP Enzyme on Gluten Digestion

NCT01335503 | Completed

• 1 other identifier: AN-PEP-02
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Gluten Digestion

Keywords

gluten

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• Effect of AN-PEP with a low or high caloric meal on gluten degradation in the stomach

  0-240 min

• Effect of meal caloric density on gastric emptying

  0-240 min

• Effect of AN-PEP and meal caloric density on gastric and duodenal pH

  0-240 min

• Effect of caloric density on AN-PEP-mediated gluten degradation in the duodenum

  0-240 min

• Effect of caloric density on AN-PEP-mediated gluten degradation in the stomach

  0-240 min

Study Arms (4)

AN-PEP with low caloric meal

ACTIVE COMPARATOR

Dietary Supplement: AN-PEP

AN-PEP with high caloric meal

ACTIVE COMPARATOR

Dietary Supplement: AN-PEP

Placebo with low caloric meal

PLACEBO COMPARATOR

Dietary Supplement: AN-PEP

Placebo with high caloric meal

PLACEBO COMPARATOR

Dietary Supplement: AN-PEP

Interventions

AN-PEP DIETARY_SUPPLEMENT

Endoprotease enzyme (AN-PEP)

Also known as: Aspergillus Niger Prolyl EndoProtease enzyme (AN-PEP)

AN-PEP with high caloric meal; AN-PEP with low caloric meal; Placebo with high caloric meal; Placebo with low caloric meal

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• DSM Food Specialties: lead

Study Sites (1)

Maastricht University

Maastricht, Netherlands

Location

Related Publications (2)

• Bartholome R, Salden B, Vrolijk MF, Troost FJ, Masclee A, Bast A, Haenen GR. Paracetamol as a Post Prandial Marker for Gastric Emptying, A Food-Drug Interaction on Absorption. PLoS One. 2015 Sep 9;10(9):e0136618. doi: 10.1371/journal.pone.0136618. eCollection 2015.

  PMID: 26352940 DERIVED

• Salden BN, Monserrat V, Troost FJ, Bruins MJ, Edens L, Bartholome R, Haenen GR, Winkens B, Koning F, Masclee AA. Randomised clinical study: Aspergillus niger-derived enzyme digests gluten in the stomach of healthy volunteers. Aliment Pharmacol Ther. 2015 Aug;42(3):273-85. doi: 10.1111/apt.13266. Epub 2015 Jun 4.

  PMID: 26040627 DERIVED

Study Officials

• Ad Masclee, Prof Dr

  Maastricht University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2011
• First Posted: April 14, 2011
• Study Start: April 1, 2011
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: August 13, 2013

Record last verified: 2013-08

Locations

NL (1)