Status:
COMPLETED
Bread Study: Comparison of the Tolerance of Spelt and Wheat Bread
Lead Sponsor:
University of Hohenheim
Conditions:
Non-celiac Gluten Sensitivity
Wheat Intolerance
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief 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 inf...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 7 2021
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04401956
Start Date
May 15 2020
End Date
September 7 2021
Last Update
October 27 2021
Active Locations (1)
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1
University of Hohenheim
Stuttgart, Germany, 70599