Development of a Celiac Safe Food Additive

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.

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Key information

Conditions

Gluten Intolerance Celiac Disease Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Malabsorption Syndromes Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chalmers University of Technology

Gothenburg, 41296, Sweden

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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Withdrawn consent: Participant withdraws consent.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)

Treatment and study plan

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

Other

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.

Primary outcomes

Levels of deamidated gliadin peptides in blood

Time frame: 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

Sponsors and collaborators

Lead sponsor

Chalmers University of Technology

Other

Collaborators

Gothia Forum - Center for Clinical Trial
Sahlgrenska University Hospital

Registry information

Official study title

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

Important dates

Study start: 2020
Primary completion: 2020
Study completion: 2020
First posted: Aug 22, 2023
Registry last updated: Aug 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed