Clinical Trials Logo

Clinical Trial Summary

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.


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04401956
Study type Interventional
Source University of Hohenheim
Contact
Status Completed
Phase N/A
Start date May 15, 2020
Completion date September 7, 2021

See also
  Status Clinical Trial Phase
Recruiting NCT05555446 - Bovine Colostrum to Prevent Absorption of Gluten Early Phase 1
Completed NCT02472704 - Lymphocytic Enteritis and Suspected Coeliac Disease: Gluten vs Placebo N/A
Completed NCT03775499 - Probiotic BL NCC 2705 and Gluten Sensitivity N/A
Completed NCT05779358 - Gluten and (Extra-)Intestinal Symptoms in NCGS N/A
Recruiting NCT05238545 - The Effect of Gluten-free Diet on Parkinsonism N/A
Recruiting NCT06338891 - Can Gluten/Wheat or Other Foods be Responsible for FMF Attacks
Recruiting NCT05644795 - Wheat-free Diet in the Treatment of Sjogren's Syndrome N/A
Completed NCT04377061 - Anemia in Non-celiac Wheat Sensitivity
Completed NCT04077840 - Autoimmune Diseases and Serum Autoantibodies in NCWS and IBS Patients
Completed NCT04769180 - Extraintestinal Non Celiac Wheat Sensitivity
Recruiting NCT06191432 - Tolerability of an Ancient Grain in Patients With Non-Celiac Wheat Sensitivity N/A
Completed NCT04017585 - Identification of Gluten Sensitivity in Irritable Bowel Syndrome N/A
Recruiting NCT02810301 - Efficacy of Probiotic ES1 for the Treatment of Non-Celiac Gluten Sensitivity Phase 2
Recruiting NCT06152445 - Wheat Bread Study: Comparison of the Tolerance of Different Wheat Breads N/A