NCT06005376

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 29, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 2, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 2, 2020

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

August 8, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 22, 2023

Completed
Last Updated

August 22, 2023

Status Verified

August 1, 2023

Enrollment Period

3 months

First QC Date

August 8, 2023

Last Update Submit

August 17, 2023

Conditions

Gluten Intolerance

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

No additive

ACTIVE COMPARATOR

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

E304i/zinc additive

EXPERIMENTAL

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

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.

E304i/zinc additiveNo additive

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chalmers University of Technology

Gothenburg, 41296, Sweden

Location

Related Publications (1)

  • Engstrom N, Bohn L, Josefsson A, Storsrud S, Scheers N. Development of celiac-safe foods: prevention of transglutaminase 2 (TG2) deamidation of gluten in healthy non-celiac volunteers. Front Nutr. 2024 Mar 14;11:1308463. doi: 10.3389/fnut.2024.1308463. eCollection 2024.

    PMID: 38549745DERIVED

MeSH Terms

Conditions

Celiac Disease

Condition Hierarchy (Ancestors)

Malabsorption SyndromesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Nathalie Scheers

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Masking Details
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.
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Model Details: Randomised double-blind crossover intervention
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

August 8, 2023

First Posted

August 22, 2023

Study Start

July 29, 2020

Primary Completion

November 2, 2020

Study Completion

November 2, 2020

Last Updated

August 22, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL
Time Frame
As soon as published, no time limit
Access Criteria
The study will be published in an open access journal

Locations

SE(1)