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Development of a Celiac Safe Food Additive

NCT06005376 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2023-08-22

No results posted yet for this study

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.

Conditions

  • Gluten Intolerance

Interventions

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.

Sponsors & Collaborators

  • Gothia Forum - Center for Clinical Trial

    collaborator OTHER

  • Sahlgrenska University Hospital

    collaborator OTHER

  • Chalmers University of Technology

    lead OTHER

Principal Investigators

  • Nathalie Scheers · Chalmers University of Technology, Dept of Life Sciences, Gothenburg 412 96, Sweden

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-07-29
Primary Completion
2020-11-02
Completion
2020-11-02

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06005376 on ClinicalTrials.gov