A randomised, double-blind, cross-over trial to evaluate bread, in which gluten has been pre-digested by prolyl endoprotease treatment, in subjects self-reporting benefits of adopting a gluten-free or low-gluten diet

Dinka Rees, Grietje Holtrop, Gemma Chope, Kim-Marie Moar, Morven Cruickshank, Nigel Hoggard

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Abstract

The aim of the present study was to determine if the enzyme Aspergillus niger prolyl endoprotease (ANPEP), which degrades the immunogenic proline-rich residues in gluten peptides, can be used in the development of new wheat products, suitable for gluten sensitive (GS) individuals. We have carried out a double-blind, randomised, cross-over trial with two groups of adults; subjects, self-reporting benefits of adopting a gluten-free or low-gluten diet (GS) n=16 and a control non-GS group n=12. For the trial, volunteers consumed four wheat breads: normal bread, bread treated with 0.8% or 1% ANPEP and low-protein bread made from biscuit flour. Compared to controls, GS subjects had a favourable cardiovascular lipid profile - lower LDL (4.0 ± 0.3 vs. 2.8 ± 0.2 mmol/L; P=0.008) and LDL/HDL ratio (3.2 ± 0.4 vs. 1.8 ± 0.2; P=0.005) and modified haematological profile. The majority of the GS subjects followed a low-gluten lifestyle, which helps to reduce the GI symptoms severity. The low-gluten lifestyle does not have any effect on the quality of life, fatigue or mental state of this population. Consumption of normal wheat bread increased GI symptoms in GS subjects compared with their habitual diet. ANPEP lowered the immunogenic gluten in the treated bread by approximately 40%. However, when compared to the control bread for inducing GI symptoms, no treatment effects were apparent. ANPEP can be applied in the production of bread with taste, texture and appearance comparable to standard bread.
Original languageEnglish
Pages (from-to)496-506
Number of pages11
JournalBritish Journal of Nutrition
Volume119
Issue number5
Early online date6 Mar 2018
DOIs
Publication statusPublished - 14 Mar 2018

Bibliographical note

Acknowledgements

We are grateful for the support of the staff from the Rowett Institute Human Nutrition Unit.

The present study was supported by a grant (Bakery Products for Non-Coeliac Gluten sensitive Consumers) from Innovate UK (101740). The funder Innovate UK had no role in the design, analysis or writing of this article. Warburton Ltd. provided the experimental bread. DSM Food Specialities B.V. provided the protease ANPEP. The study is registered under the Clinical Trials Identifier: NCT02308397.

NH proposed the study concept. NH and DR designed research. DR recruited the subjects and carried out the intervention, laboratory analysis, data collection and collation. MC and KM helped with recruitment. GC performed the analysis of the breads. GH and DR analysed the data. DR prepared the manuscript; NH had primary responsibility for final content. All authors read and approved the final manuscript. The authors have no financial or personal conflicts of interest to declare.

Keywords

  • gluten sensitive
  • gastrointestinal symptoms
  • lipid profile
  • enzyme
  • ANPEP

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