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Development of a Celiac Safe Food Additive

Primary Purpose

Gluten Intolerance

Status

Completed

Phase

Not Applicable

Locations

Sweden

Study Type

Interventional

Intervention

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

About this trial

This is an interventional supportive care trial for Gluten Intolerance

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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 Withdrawn consent: Participant withdraws consent.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)

Sites / Locations

Chalmers University of Technology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

No additive

E304i/zinc additive

Arm Description

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

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

Outcomes

Primary Outcome Measures

Levels of deamidated gliadin peptides in blood

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

Secondary Outcome Measures

Full Information

NCT ID

NCT06005376

First Posted

August 8, 2023

Last Updated

August 17, 2023

Sponsor

Chalmers University of Technology

Collaborators

Gothia Forum - Center for Clinical Trial, Sahlgrenska University Hospital, Sweden

1. Study Identification

Unique Protocol Identification Number

NCT06005376

Brief Title

Development of a Celiac Safe Food Additive

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Completed

Study Start Date

July 29, 2020 (Actual)

Primary Completion Date

November 2, 2020 (Actual)

Study Completion Date

November 2, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Chalmers University of Technology

Collaborators

Gothia Forum - Center for Clinical Trial, Sahlgrenska University Hospital, Sweden

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gluten Intolerance

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Model Description

Randomised double-blind crossover intervention

Masking

ParticipantCare Provider

Masking Description

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.

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

No additive

Arm Type

Active Comparator

Arm Description

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

Arm Title

E304i/zinc additive

Arm Type

Experimental

Arm Description

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

Intervention Type

Other

Intervention Name(s)

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

Intervention Description

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 Outcome Measure Information:

Title

Levels of deamidated gliadin peptides in blood

Description

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nathalie Scheers

Organizational Affiliation

Chalmers University of Technology, Dept of Life Sciences, Gothenburg 412 96, Sweden

Official's Role

Principal Investigator

Facility Information:

Facility Name

Chalmers University of Technology

City

Gothenburg

ZIP/Postal Code

41296

Country

Sweden

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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

Learn more about this trial

Development of a Celiac Safe Food Additive

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