NCT06005376

Development of a Celiac Safe Food Additive

Development of a Celiac Safe Food Additive: An Intervention Study in Healthy Volunteers

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Chalmers University of Technology · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Gluten Intolerance

Interventions

Type	Name	Description
OTHER	Breakfast 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.

Timeline

• Start date: 2020-07-29
• Primary completion: 2020-11-02
• Completion: 2020-11-02
• First posted: 2023-08-22
• Last updated: 2023-08-22

Locations

1 site across 1 country: Sweden