Bakery Products for Non-Coeliac Gluten Sensitive Consumers
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
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
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.
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|Eligible Ages||18 Years - 70 Years|
- - 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.
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.
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.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|University of Aberdeen|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Principal Investigator Affiliation||N/A|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
|Non Coeliac Gluten Sensitivity|
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.
- - a system based on strategies that the subjects use to avoid eating gluten.
- - 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.
- - IgA anti-tissue transglutaminase antibody and total IgA level.
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