- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04401956
Bread Study: Comparison of the Tolerance of Spelt and Wheat Bread
Comparison of the Tolerance of Spelt and Wheat Bread in Humans With Suspected NCWS Considering Different Manufacturing Processes of Bread
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Stuttgart, Germany, 70599
- University of Hohenheim
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Gluten free bread with added gluten
Bread will be eaten by the participants for 4 consecutive days.
|
Different types of bread
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Active Comparator: Gluten free bread with added FODMAPs
Bread will be eaten by the participants for 4 consecutive days.
|
Different types of bread
|
Experimental: Traditional manufactured wheat bread
Bread will be eaten by the participants for 4 consecutive days.
|
Different types of bread
|
Experimental: Traditional manufactured spelt bread
Bread will be eaten by the participants for 4 consecutive days.
|
Different types of bread
|
Experimental: Conventional manufactured wheat bread
Bread will be eaten by the participants for 4 consecutive days.
|
Different types of bread
|
Experimental: Conventional manufactured spelt bread
Bread will be eaten by the participants for 4 consecutive days.
|
Different types of bread
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of IBS-SSS Total score
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).)
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IBS-SSS Total score will be collected with a questionnaire
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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
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).)
|
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
Time Frame: Study examinations are at baseline and after bread intervention phases (day 7, 14, 21, 28, 35, 42).
|
Change of blood- and fecal markers that will reveal inflammation or intestinal permeability (Anti-gliadin Immunglobulin G antibody, lipase, ferritin, zonulin, calprotectin and lactoferrin)
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Study examinations are at baseline and after bread intervention phases (day 7, 14, 21, 28, 35, 42).
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ErnMed-Brot
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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