Development of a Celiac Safe Food Additive

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-29

Study Completion Date

2020-11-02

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.

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Detailed Description

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Conditions

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Gluten Intolerance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Randomised double-blind crossover intervention

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Caregivers

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.

Study Groups

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No additive

This arm was served 2 reference wheat bread rolls (a 40 g) a day.

Group Type ACTIVE_COMPARATOR

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

Intervention Type 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.

E304i/zinc additive

This arm was served 2 wheat bread rolls (a 40 g) a day containing a E304i/zinc additive.

Group Type EXPERIMENTAL

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

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes