Bakery Products for Non-Coeliac Gluten Sensitive Consumers

NCT02308397 | Unknown DMC

• 1 other identifier: Rowett 904
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

non coeliac gluten sensitivity; gluten; bread

Outcome Measures

Primary Outcomes (1)

• Change in the presence and severity of overall and individual gastrointestinal symptoms (daily diary cards via a 100-mm VAS to score)

  Gastrointestinal symptoms will be assessed by the participant completing daily diary cards via a 100-mm VAS to score the presence and severity of abdominal pain, bloating, wind and nausea.

  These will be assessed daily during baseline week (0), treatment week (1, 4, 7 and 10) and washout week (3, 6 and 9)

Secondary Outcomes (1)

• Change in the presence and severity of daily fatigue (Daily-Fatigue Impact Scale (D-FIS)

  Fatigue will be assessed daily during baseline week (0), treatment week (1, 4, 7 and 10) and washout week (3, 6 and 9)

Other Outcomes (1)

• Measurement of biomarkers as in detailed description of the study section

  These will be measured singularly during baseline week (0)

Study Arms (4)

Group 1

EXPERIMENTAL

Begins with Normal gluten containing bread

Other: Normal gluten containing bread

Group 2

EXPERIMENTAL

Begins with Bread with reduced gliadins content

Other: Bread with reduced gliadins content

Group 3

EXPERIMENTAL

Begins with Bread with reduced ATIs content

Other: Bread with reduced ATIs content

Group 4

EXPERIMENTAL

Begins with Bread with reduced overall protein content

Other: Bread with reduced overall protein content

Interventions

Normal gluten containing bread OTHER

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

Group 1

Bread with reduced gliadins content OTHER

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

Group 2

Bread with reduced ATIs content OTHER

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

Group 3

Bread with reduced overall protein content OTHER

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

Group 4

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• male or female, aged 18-70, who believe they experience non-coeliac gluten sensitivity

You may not qualify if:

• Coeliac Disease
• Wheat allergy
• Dermatitis Herpetiformis
• Gastrointestinal disorders: Small Intestinal Bowel Overgrowth (SIBO), Crohn's disease , Ulcerative Colitis, Inflammatory Bowel Disease (IBD)
• History of gastrointestinal surgery/procedure over the last 3 years
• Kidney disease
• Hepatic disease
• Active cancer
• Severe cardiovascular disease
• Addiction to any substances
• Breastfeeding/ Pregnancy
• Volunteers with poorly controlled psychiatric disease or those unable to give written informed consent will also be excluded.
• Medications for treatment of heartburn, dyspepsia, indigestion, bloating etc. e.g. gastrokinetics or prokinetics, antacids, laxatives
• Digestive enzymes

Sponsors & Collaborators

• University of Aberdeen: lead

Study Sites (1)

University of Aberdeen Rowett Institute of Nutrition and Health

Aberdeen, AB21 9SB, United Kingdom

RECRUITING

Related Publications (1)

• Rees D, Holtrop G, Chope G, Moar KM, Cruickshank M, Hoggard N. 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. Br J Nutr. 2018 Mar;119(5):496-506. doi: 10.1017/S0007114517003749.

  PMID: 29508689 DERIVED

MeSH Terms

Interventions

Bread

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Central Study Contacts

Nigel Dr Hoggard, PhD

CONTACT

n.hoggard@abdn.ac.uk

Study Design

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

Study Record Dates

• First Submitted: November 13, 2014
• First Posted: December 4, 2014
• Study Start: November 1, 2014
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: October 27, 2017

Record last verified: 2017-10

Locations

GB (1)