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Bakery Products for Non-Coeliac Gluten Sensitive Consumers

Study Purpose

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

Recruitment Criteria

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Accepts Healthy Volunteers
Yes

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Study Type
Interventional
Eligible Ages 18 Years - 70 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

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

    Exclusion Criteria:

    - Medical exclusion criteria - 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.
Medication exclusion criteria - Medications for treatment of heartburn, dyspepsia, indigestion, bloating etc. e.g. gastrokinetics or prokinetics, antacids, laxatives - Digestive enzymes

Trial Details

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

Trial ID:
NCT02308397

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase
N/A

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Lead Sponsor
University of Aberdeen

The person who is responsible for the scientific and technical direction of the entire clinical study.

Principal Investigator
N/A
Principal Investigator Affiliation N/A

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Agency Class
Other
Overall Status Recruiting
Countries United Kingdom

The disease, disorder, syndrome, illness, or injury that is being studied.

Conditions
Non Coeliac Gluten Sensitivity
Additional Details

Prior to the study each volunteer will undergo screening procedure (Health Screening Questionnaire) for compliance with the inclusion/exclusion criteria. The volunteers who meet those criteria will be invited to sign an informed consent. Following this the volunteers will be asked to complete:

  • - Gluten Sensitivity Questionnaire - SF-36 Quality of Life Questionnaire - Beacke Physical Activity Questionnaire - DASS 21 Questionnaire It is anticipated that NCGS volunteers are following a low gluten or gluten-free life style.
Evaluation of their dietary compliance with gluten-free diet will be done through using numerical scores (Biagi at al.,2009)
  • - a system based on strategies that the subjects use to avoid eating gluten.
Gastrointestinal symptoms will be assessed by the participant completing daily diary cards via a 100-mm VAS to score the presence and severity of overall abdominal symptoms, abdominal pain, bloating, wind, satisfaction with stool consistency, tiredness, and nausea. Severity of fatigue will be evaluated by the Daily-Fatigue Impact Scale (D-FIS), a questionnaire containing 8 items that evaluates the impact of fatigue on cognition, physical functioning, and daily activities. After one week of a baseline period, the subjects will be assigned to one week of dietary intervention (bread A, B, C or D), followed by 14-day wash-out period before crossing over to the next bread. All volunteers will be randomised to all four groups/cross over intervention. Treatment:
  • - Bread A - normal (gluten-containing) reference bread - Bread B - bread with reduced gliadin content - Bread C - bread with reduced ATIs - Bread D - bread with reduced overall protein content Each treatment bread will be consumed for one week (3 slices per day), followed by washout period of at least 2 weeks or until symptoms induced during the previous dietary challenge resolved.
Volunteers unable to continue a treatment due to intolerable symptoms will be permitted to cease the study food of that particular arm but can continue if they wish with the study. Bread will be provided to volunteers at the beginning of each treatment week. Compliance will be determined with questioning at time of review and counting the slices of bread left at the end of the treatment week. Pilot study For volunteers only recruited from the Aberdeen and the Aberdeenshire area as part of a pilot study we will also ask volunteers to make a single visit (at the beginning of the study) to the RINH. At this visit a fasting blood sample will be taken, the blood pressure will be checked and anthropometric measurements will be made. Blood test:
  • - IgA anti-tissue transglutaminase antibody and total IgA level.
- IgA endomysial antibody - IgG deamidated gliadin peptide antibodies (DGP-AGA) - Immunoglobulin IgG/IgA antigliadin antibodies (AGA) - Flow cytometric basophil activation test - Gliadin-specific T cells in the peripheral blood - Full blood count - Lipid profile - Vit B12 and folic acid status

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Aberdeen, United Kingdom

Status

Recruiting

Address

University of Aberdeen Rowett Institute of Nutrition and Health

Aberdeen, , AB21 9SB

Site Contact

Nigel Hoggard, PhD

N.Hoggard@abdn.ac.uk

0044 (0)1224 438655

The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.

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