Development of a Celiac Safe Food Additive

Study Overview
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Brief Summary
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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.

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

Conditions
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Gluten Intolerance

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


Participation Criteria
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Eligibility Criteria
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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 Withdrawn consent: Participant withdraws consent.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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Randomised double-blind crossover intervention
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: No additive<br>This arm was served 2 reference wheat bread rolls (a 40 g) a day. | Other: Breakfast rolls consisting of wheat flour with and without a E304i/zinc additive<br>* 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.<br>|
| Experimental: E304i/zinc additive<br>This arm was served 2 wheat bread rolls (a 40 g) a day containing a E304i/zinc additive. | Other: Breakfast rolls consisting of wheat flour with and without a E304i/zinc additive<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Levels of deamidated gliadin peptides in blood | Deamidated gliadin peptides in blood measured by ELISA using an antibody towards deamidated gliadin peptides | Blood samples were drawn once weekly at day 7, 14, 21, 28 |