Development of a Celiac Safe Food Additive
Not Applicable
Completed
- Conditions
- Gluten Intolerance
- Interventions
- Other: Breakfast rolls consisting of wheat flour with and without a E304i/zinc additive
- Registration Number
- NCT06005376
- Lead Sponsor
- Chalmers University of Technology
- Brief Summary
The goal of this clinical trial was to investigate if intestinal deamidation of gliadin from wheat bread could be hindered by adding a E304i/zinc additive. The study was a randomized double-blind 4-week crossover intervention in 20 healthy volunteers in which the participants ingested 2 bread rolls a day during the intervention weeks.
The question it aimed to answer was if there was a difference in blood levels of deamidated gliadin peptides after ingestion of the reference wheat bread compared with the wheat bread containing the food additive.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
- Signed informed consent
- Body mass index between 18.5 to 32
- Age between 18-50 years
- No tobacco use
Exclusion Criteria
- Celiac disease and other diagnosed enteropathies
- Gluten-free diet
- Dietary supplementation (minerals (calcium, zinc, vitamin D) and proteolytic enzymes, probiotics)
- Pregnancy or lactation
- Lack of suitability for participation in the study, for any reason, as judged by the medical doctor or the project PI.
- Withdrawn consent: Participant withdraws consent.
- Non-compliance: Participant fails repeatedly to comply with study protocol (diet, study visits and provide samples)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description No additive Breakfast rolls consisting of wheat flour with and without a E304i/zinc additive This arm was served 2 reference wheat bread rolls (a 40 g) a day. E304i/zinc additive Breakfast rolls consisting of wheat flour with and without a E304i/zinc additive This arm was served 2 wheat bread rolls (a 40 g) a day containing a E304i/zinc additive.
- Primary Outcome Measures
Name Time Method Levels of deamidated gliadin peptides in blood Blood samples were drawn once weekly at day 7, 14, 21, 28 Deamidated gliadin peptides in blood measured by ELISA using an antibody towards deamidated gliadin peptides
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Chalmers University of Technology
🇸🇪Gothenburg, Sweden