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- Title
Randomised clinical study: Aspergillus niger-derived enzyme digests gluten in the stomach of healthy volunteers.
- Authors
Salden, B. N.; Monserrat, V.; Troost, F. J.; Bruins, M. J.; Edens, L.; Bartholomé, R.; Haenen, G. R.; Winkens, B.; Koning, F.; Masclee, A. A.
- Abstract
Background Aspergillus niger prolyl endoprotease (AN-PEP) efficiently degrades gluten molecules into non-immunogenic peptides in vitro. Aim To assess the efficacy of AN-PEP on gluten degradation in a low and high calorie meal in healthy subjects. Methods In this randomised, double-blind, placebo-controlled, cross-over study 12 healthy volunteers attended to four test days. A liquid low or high calorie meal (4 g gluten) with AN-PEP or placebo was administered into the stomach. Via a triple-lumen catheter gastric and duodenal aspirates were sampled, and polyethylene glycol (PEG)-3350 was continuously infused. Acetaminophen in the meals tracked gastric emptying time. Gastric and duodenal samples were used to calculate 240-min area under the curve (AUC0-240 min) of α-gliadin concentrations. Absolute α-gliadin AUC0-240 min was calculated using duodenal PEG-3350 concentrations. Results AN-PEP lowered a-gliadin concentration AUC0-240 min, compared to placebo, from low and high calorie meals in stomach (low: 35 vs. 389 μg × min/mL; high: 53 vs. 386 μg × min/mL; P < 0.001) and duodenum (low: 7 vs. 168 μg × min/mL; high: 4 vs. 32 μg × min/mL; P < 0.001) and absolute a-gliadin AUC0-240 min in the duodenum from low (2813 vs. 31 952 μg × min; P < 0.001) and high (2553 vs. 13 095 μg × min; P = 0.013) calorie meals. In the placebo group, the high compared to low calorie meal slowed gastric emptying and lowered the duodenal a-gliadin concentration AUC0-240 min (32 vs. 168 μg × min/mL; P = 0.001). Conclusions AN-PEP significantly enhanced gluten digestion in the stomach of healthy volunteers. Increasing caloric density prolonged gastric residence time of the meal. Since AN-PEP already degraded most gluten from low calorie meals, no incremental effect was observed by increasing meal caloric density. Clinical- Trials.gov, Number: NCT01335503; www.trialregister.nl, Number: NTR2780.
- Subjects
ASPERGILLUS niger; ENZYMES; GLUTEN; STOMACH; POLYETHYLENE glycol
- Publication
Alimentary Pharmacology & Therapeutics, 2015, Vol 42, Issue 3, p273
- ISSN
0269-2813
- Publication type
Article
- DOI
10.1111/apt.13266