Development of a Celiac Safe Food Additive

Chalmers University of Technology20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Enrollment

Conditions

Gluten Intolerance

Interventions

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

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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 * Withdrawn consent: Participant withdraws consent.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)

Locations (1)

Chalmers University of Technology

Gothenburg, Sweden

Outcomes

Primary Outcomes

Levels of deamidated gliadin peptides in blood

Deamidated gliadin peptides in blood measured by ELISA using an antibody towards deamidated gliadin peptides

Time frame: Blood samples were drawn once weekly at day 7, 14, 21, 28

Data from ClinicalTrials.gov

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