Bread Study: Comparison of the Tolerance of Spelt and Wheat Bread

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Comparison of the Tolerance of Spelt and Wheat Bread in Humans With Suspected NCWS Considering Different Manufacturing Processes of Bread

Conditions
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Non-celiac Gluten Sensitivity, Wheat Intolerance

Intervention / Treatment
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* Other: bread


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥18 ≤70 years Signed declaration of consent Willingness to adhere to the prescribed diet for the duration of the study Subjective bread wheat intolerance No known spelled intolerance No acute or chronic gastrointestinal diseases (e.g. celiac disease / wheat allergy) No participation in another clinical trial (current or within the past 30 days) Gluten-containing diet at least 6 weeks before the start of the study Exclusion Criteria: Taking intestinal therapeutics, antibiotics, immunosuppressants or similar Pregnancy / lactation Relevant violations of the nutritional protocol Occurrence of relevant diseases (possibly individual decision) Revocation of consent Accommodation in a clinic or similar facility based on an official or judicial order

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Gluten free bread with added gluten<br>Bread will be eaten by the participants for 4 consecutive days. | Other: bread<br>* Different types of bread<br>|
| Active Comparator: Gluten free bread with added FODMAPs<br>Bread will be eaten by the participants for 4 consecutive days. | Other: bread<br>* Different types of bread<br>|
| Experimental: Traditional manufactured wheat bread<br>Bread will be eaten by the participants for 4 consecutive days. | Other: bread<br>* Different types of bread<br>|
| Experimental: Traditional manufactured spelt bread<br>Bread will be eaten by the participants for 4 consecutive days. | Other: bread<br>* Different types of bread<br>|
| Experimental: Conventional manufactured wheat bread<br>Bread will be eaten by the participants for 4 consecutive days. | Other: bread<br>* Different types of bread<br>|
| Experimental: Conventional manufactured spelt bread<br>Bread will be eaten by the participants for 4 consecutive days. | Other: bread<br>* Different types of bread<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of IBS-SSS Total score | IBS-SSS Total score will be collected with a questionnaire | 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).) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Extraintestinal Symptoms | The study team will ask the participants for typical extraintestinal symptoms in NCWS like headache, foggy-mind, nausea, heartburn, exhaustion | 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) | Study examinations are at baseline and after bread intervention phases (day 7, 14, 21, 28, 35, 42). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Human Nutrition, NCWS, Spelt, Wheat Bread