Gluten Intolerance
Conditions
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.
Interventions
OTHERBreakfast rolls consisting of wheat flour with and without a E304i/zinc additive
The participants were provided with two Breakfast rolls (a 40 g) a day during the intervention week. In addition, they were provided with gluten-free foods during the whole trial.
Sponsors
Gothia Forum - Center for Clinical Trial
Sahlgrenska University Hospital
Chalmers University of Technology
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Caregiver)
Masking description
The participants did not know which bread was received; the bags were color-coded. The personnel meeting the participants did not know which color belonged to which bread. Only the principal investigator (and the bakery) not meeting participants knew which color belonged to which bread type.
Intervention model description
Randomised double-blind crossover intervention
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
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 * Withdrawn consent: Participant withdraws consent.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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Sweden
Outcome results
None listed