CompletedNot Applicable

Effects of Different Bread Types in NCWS

Netherlands40 participantsStarted 2019-09-17

Plain-language summary

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 wheat sensitivity (NCWS) is accompanied by a range of (extra-)intestinal complaints soon after consuming wheat, which improve after wheat 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 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 in individuals with NWGS using two double-blind randomized cross-over design (study A and B). Subjects are required to avoid any products that cause GI symptoms (e.g. wheat products) during the trial. The investigators hypothesize that grain type and processing will have a different effect on the primary outcomes. In addition, we want to explore the in vitro effect of each bread type on gut microbiota composition and activity.

Who can participate

Age range18 Years – 70 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Develops of self-reported GI symptoms within 12 hours after a single intake of bread; * Age between 18-70 years; * Asymptomatic or only mildly symptomatic (overall) GI symptoms score with VAS \< 30mm) while on the gluten-free/gluten-restricted diet; * Must have a freezer (-18ºC) to store the study breads during the study; * Willing and able to give written informed consent and to understand, participate and comply with the research project requirements. Exclusion Criteria: * Medical history of coeliac disease, wheat allergy, inflammatory bowel disease, presence of an organic gastrointestinal (GI) disease (such as inflammatory bowel disease) or other disease which may interfere with NCWS symptoms (upon judgment of the physician-clinical investigator (Dr. Keszthelyi, Gastroenterologist MUMC+)); * Previous major abdominal surgery or radiotherapy interfering with gastrointestinal function: * Uncomplicated appendectomy, cholecystectomy and hysterectomy allowed unless within the past 6 months; * Other surgery may be allowed based upon judgment of the physician-clinical investigator (Dr. Keszthelyi, Gastroenterologist MUMC+), who will decide on inor exclusion based upon the surgery applied; * Use of medication potentially influencing gastrointestinal function and/or NCWS symptoms is allowed, provided that dosing has been stable for ≥ 1 month before enrolment; * Administration of probiotic, prebiotic supplements, investigational drugs or participation in…

What they're measuring

Overall GI symptom score

Timeframe: At the end of day 1, 2 and 3 of the run-in period, at the end of test day 1, 2 and 3, and at the end of the last three days of each wash-out period (so the three days prior to testday 2 and 3).

Trial details

NCT IDNCT04084470

SponsorMaastricht University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-12-20