An interventional study of bread in Non-celiac Gluten Sensitivity and Wheat Intolerance, sponsored by University of Hohenheim. Completed at 1 site in Germany. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-10-27.
Sponsored by University of Hohenheim · Not applicable, Interventional, and Supportive care
This project aims to verify the hypothesis that spelt products are more tolerable than bread wheat products in a target group of individuals with self-diagnosed wheat sensitivity. In addition, the influence of different manufacturing processes will be considered.
Wheat cereals are known to be capable of triggering wheat allergy and celiac disease. The prevalence of both diseases is about 1%. Recently, another clinical entity was described, the non-celiac wheat sensitivity (NCWS). The origin and mechanisms of NCWS are unclear at present, but the existence of this new disease entity has been proven by double-blind placebo-controlled challenge tests. Three different grain components have been proposed as triggers of NCWS, gluten, α-amylase trypsin inhibitors or fermentable carbohydrates (FODMAPs).
It is reported that individuals with self-diagnosed NCWS quite often tolerate spelt products much better, even though spelt shows a higher gluten content than bread wheat products. Therefore, the question arises whether this putative spelt tolerance can be confirmed on an objective basis and whether the underlying molecular mechanisms can be elucidated. So far, human study addressing such questions are lacking.
This project aims to verify the hypothesis that spelt products are more tolerable than bread wheat products in a target group of individuals with self-diagnosed wheat sensitivity. In addition, the influence of different manufacturing processes on wheat sensitivity will be revealed.
For this purpose, the trial involves individuals with self-diagnosed wheat sensitivity and spelt tolerance. Six different kinds of bread will be tested, including 4 wheat and spelt breads, each of them produced following a traditional or a conventional way. Aim of this part is to objective bread wheat and spelt intolerance in a defined population. To find out whether FODMAPs or gluten affect the tolerance of bread, two additional breads will be tested, a gluten-free bread with added gluten and a gluten-free bread with added FODMAPs.
1,916 studies on the registry are indexed under Hypersensitivity; 265 are open to participants now.
This study's enrollment of 24 is below the median of 57 across 1,384 interventional studies indexed under Hypersensitivity.
Browse Hypersensitivity studies →University of Hohenheim is the lead sponsor of 42 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Bread will be eaten by the participants for 4 consecutive days.
Other: bread
Bread will be eaten by the participants for 4 consecutive days.
Other: bread
Bread will be eaten by the participants for 4 consecutive days.
Other: bread
Bread will be eaten by the participants for 4 consecutive days.
Other: bread
Bread will be eaten by the participants for 4 consecutive days.
Other: bread
Bread will be eaten by the participants for 4 consecutive days.
Other: bread
Different types of bread
Change of IBS-SSS Total score
IBS-SSS Total score will be collected with a questionnaire
Time frame: Study examinations are at baseline, after wash out phases (day 3, 10, 17, 24, 31, 38) and after bread intervention phases (day 7, 14, 21, 28, 35, 42).)
Extraintestinal Symptoms
The study team will ask the participants for typical extraintestinal symptoms in NCWS like headache, foggy-mind, nausea, heartburn, exhaustion
Time frame: Study examinations are at baseline, after wash out phases (day 3, 10, 17, 24, 31, 38) and after bread intervention phases (day 7, 14, 21, 28, 35, 42).)
Blood and fecal markers
Change of blood- and fecal markers that will reveal inflammation or intestinal permeability (Anti-gliadin Immunglobulin G antibody, lipase, ferritin, zonulin, calprotectin and lactoferrin)
Time frame: Study examinations are at baseline and after bread intervention phases (day 7, 14, 21, 28, 35, 42).
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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University of Hohenheim