Development of a Celiac Safe Food Additive

Chalmers University of Technology

Status

Completed

Conditions

Gluten Intolerance

Treatments

Other: Breakfast rolls consisting of wheat flour with and without a E304i/zinc additive

Study type

Interventional

Funder types

Other

Identifiers

NCT06005376

2019F004

Details and patient eligibility

About

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.

Enrollment

20 patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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Withdrawn consent: Participant withdraws consent.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)