Although wheat and gluten containing food products are generally considered to be healthy, a large number of individuals in the general population reduces or limits their intake and/or replaces wheat by other grains because of possible symptoms. This non-coeliac gluten/wheat sensitivity (NCGS/NCWS) is accompanied by a range of (extra-)intestinal complaints soon after consuming wheat or gluten, which improve after wheat/gluten withdrawal. Evidence for a biological mechanism and for the exact contributing compound is limited. Furthermore, the impact of grain type, bread processing and the resulting compositional changes in bread on gastrointestinal tolerability in NCGS/NCWS is unclear, especially as consumed part of a typical daily human diet. The objective of this study is to investigate the effects of well-characterised breads on (extra-)intestinal symptoms, gut microbiota composition and activity, metabolite profiles, and innate immune function in individuals with NCGS using a three-arm randomized cross-over design. Subjects are required to adhere to a gluten-free diet during the trial. The investigators hypothesize that grain type and processing will have a different effect on the primary outcomes.
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
Study Type
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. |
Interventional |
Eligible Ages | 18 Years - 70 Years |
Gender | All |
Trial ID:
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. |
NCT04084470 |
Phase
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. |
N/A |
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Maastricht University |
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Daisy MAE Jonkers, Prof., PhD |
Principal Investigator Affiliation | Maastricht University |
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Other |
Overall Status | Recruiting |
Countries | Netherlands |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Non-Coeliac Gluten Sensitivity (NCGS), Non-Coeliac Wheat Sensitivity (NCWS) |
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