Development of a Celiac Safe Food Additive

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

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 Overview

• Status: Completed
• Conditions: Gluten Intolerance
• Intervention / Treatment: Other: Breakfast rolls consisting of wheat flour with and without a E304i/zinc additive

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Gothenburg, Sweden, 41296
    • Chalmers University of Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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• Withdrawn consent: Participant withdraws consent.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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: No additive; 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; 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.
Experimental: E304i/zinc additive; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Chalmers University of Technology
• Collaborators: Sahlgrenska University Hospital, Sweden; Gothia Forum - Center for Clinical Trial
• Investigators: Principal Investigator: Nathalie Scheers, Chalmers University of Technology, Dept of Life Sciences, Gothenburg 412 96, Sweden

Study record dates

Study Major Dates

• Study Start (Actual): July 29, 2020
• Primary Completion (Actual): November 2, 2020
• Study Completion (Actual): November 2, 2020

Study Registration Dates

• First Submitted: August 8, 2023
• First Submitted That Met QC Criteria: August 17, 2023
• First Posted (Actual): August 22, 2023

Study Record Updates

• Last Update Posted (Actual): August 22, 2023
• Last Update Submitted That Met QC Criteria: August 17, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Metabolic Diseases; Gastrointestinal Diseases; Intestinal Diseases; Malabsorption Syndromes; Celiac Disease
• Other Study ID Numbers: 2019F004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data and the study protocol will be published in a scientific journal. Participant data are anonymized and cannot be connected to an individual person.
• IPD Sharing Time Frame: As soon as published, no time limit
• IPD Sharing Access Criteria: The study will be published in an open access journal
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No