Effect of AN-PEP Enzyme on Gluten Digestion

DSM Nutritional Products

Status: Completed

Conditions: Gluten Digestion

Treatments: Dietary Supplement: AN-PEP

Study type: Interventional

Funder types: Industry

Identifiers

NCT01335503

AN-PEP-02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 patients

Sex: All

Ages: 18 to 44 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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12 participants in 4 patient groups, including a placebo group

AN-PEP with low caloric meal

Active Comparator group

Treatment:

Dietary Supplement: AN-PEP

AN-PEP with high caloric meal

Active Comparator group

Treatment:

Dietary Supplement: AN-PEP

Placebo with low caloric meal

Placebo Comparator group

Treatment:

Dietary Supplement: AN-PEP

Placebo with high caloric meal

Placebo Comparator group

Treatment:

Dietary Supplement: AN-PEP