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Bakery Products for Non-Coeliac Gluten Sensitive Consumers

NCT02308397 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2017-10-27

No results posted yet for this study

Summary

The aim of the study is to produce a tolerable alternative to normal wheat bread which would be suitable for subjects with self-reported non-coeliac gluten sensitivity (NCGS). The bread would be made from wheat so, in contrast to gluten-free bread, would be more comparable to standard bread. To make this bread, the investigators will use advanced enzyme technology and/or novel formulations to target the digestion or removal of wheat proteins, which might be involved in the etiology of non-coeliac gluten sensitivity, preferentially over other those that are more useful for baking quality. The investigators will determine palatability and tolerance of this new product in a human cross-over, randomised, blind and placebo-controlled intervention study.

It has been estimated 6-10% of the population are sensitive to gluten who do not have coeliac disease (CD). Three breads will be produced and tested in this study against a suitable reference based on standard wheat flour and baking process

Conditions

  • Non Coeliac Gluten Sensitivity

Interventions

OTHER

Normal gluten containing bread

Group 1 will begin with Normal gluten containing bread(A) and then move to bread B,C and D

OTHER

Bread with reduced gliadins content

Group 2 will begin with Bread with reduced gliadins content (B) and then move to bread A, C and D

OTHER

Bread with reduced ATIs content

Group 3 will begin with Bread with reduced ATIs content (C) and then move to bread A, B and D

OTHER

Bread with reduced overall protein content

Group 4 will begin with Bread with reduced overall protein content (D) d then move to bread A, B and C

Sponsors & Collaborators

  • University of Aberdeen

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2018-03-31
Completion
2018-03-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02308397 on ClinicalTrials.gov