Status:

COMPLETED

Development of a Celiac Safe Food Additive

Lead Sponsor:

Chalmers University of Technology

Collaborating Sponsors:

Gothia Forum - Center for Clinical Trial

Sahlgrenska University Hospital

Conditions:

Gluten Intolerance

Eligibility:

All Genders

18-50 years

Phase:

NA

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-we...

Eligibility Criteria

Inclusion

  • Signed informed consent
  • Body mass index between 18.5 to 32
  • Age between 18-50 years
  • No tobacco use

Exclusion

  • 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  • Withdrawn consent: Participant withdraws consent.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)

Key Trial Info

Start Date :

July 29 2020

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

November 2 2020

Estimated Enrollment :

20 Patients enrolled

Trial Details

Trial ID

NCT06005376

Start Date

July 29 2020

End Date

November 2 2020

Last Update

August 22 2023

Active Locations (1)

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Chalmers University of Technology

Gothenburg, Sweden, 41296