Gluten IntoleranceNCT06005376
Development of a Celiac Safe Food Additive
A study testing Breakfast rolls consisting of wheat flour with and without a E304i/zinc additive in people with Gluten Intolerance, run by Chalmers University of Technology at 1 site in Sweden.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Gluten Intolerance
- What is being tested?
- Breakfast rolls consisting of wheat flour with and without a E304i/zinc additive
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSweden
- Study dates
- 29 Jul 2020to 2 Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Signed informed consent
- Body mass index between 18.5 to 32
- Age between 18-50 years
- No tobacco use
Who cannot join
- 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- Withdrawn consent: Participant withdraws consent.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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Gluten Intolerance
- Being tested
- Breakfast rolls consisting of wheat flour with and without a E304i/zinc additive
- Medical subject headings
- Celiac Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| No additive | Active comparator | This arm was served 2 reference wheat bread rolls (a 40 g) a day. Receives: 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. Receives: Other: Breakfast rolls consisting of wheat flour with and without a E304i/zinc additive |
What is being measured
The primary outcome is the main question the study is designed to answer.
Levels of deamidated gliadin peptides in blood
Deamidated gliadin peptides in blood measured by ELISA using an antibody towards deamidated gliadin peptides
Measured: Blood samples were drawn once weekly at day 7, 14, 21, 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2023
- Study start29 Jul 2020
- Primary completion2 Nov 2020
- Study completion2 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gluten IntoleranceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomised double-blind crossover intervention
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chalmers University of Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Gothia Forum - Center for Clinical Trial, Sahlgrenska University Hospital
- Responsible party
- Principal investigator, Nathalie Scheers, Chalmers University of Technology
- Investigators
- Nathalie Scheers, Principal investigator, Chalmers University of Technology, Dept of Life Sciences, Gothenburg 412 96, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06005376
- Sponsor's protocol ID
- 2019F004
- Status last verified
- Aug 2023
- First submitted
- 8 Aug 2023
- Last updated
- 22 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 38549745
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Celiac Safe Food Additive: An Intervention Study in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT06005376
- Acronym / sponsor ID
- 2019F004
- Conditions
- Gluten Intolerance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Chalmers University of TechnologyUniversity, hospital or other
- Collaborators
- Gothia Forum - Center for Clinical Trial, Sahlgrenska University Hospital
- Study start
- 29 Jul 2020 (actual)
- Primary completion
- 2 Nov 2020 (actual)
- Study completion
- 2 Nov 2020 (actual)
- First posted
- 22 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Randomised double-blind crossover intervention
| Arm | Type | Receives |
|---|---|---|
| No additive | Active comparator | Other: Breakfast rolls consisting of wheat flour with and without a E304i/zinc additiveThis arm was served 2 reference wheat bread rolls (a 40 g) a day. |
| E304i/zinc additive | Experimental | Other: Breakfast rolls consisting of wheat flour with and without a E304i/zinc additiveThis arm was served 2 wheat bread rolls (a 40 g) a day containing a E304i/zinc additive. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Signed informed consent
- Body mass index between 18.5 to 32
- Age between 18-50 years
- No tobacco use
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breakfast rolls consisting of wheat flour with and without a E304i/zinc additiveThe 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. | Other | E304i/zinc additive, No additive |
Primary outcome
Levels of deamidated gliadin peptides in blood
Time frame: Blood samples were drawn once weekly at day 7, 14, 21, 28
Deamidated gliadin peptides in blood measured by ELISA using an antibody towards deamidated gliadin peptides
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2023.
- Derived from this study: PubMed 38549745Engstrom 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nathalie Scheers principal investigator
Chalmers University of Technology, Dept of Life Sciences, Gothenburg 412 96, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breakfast rolls consisting of wheat flour with and without a E304i/zinc additive in people with Gluten Intolerance, run by Chalmers University of Technology at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Levels of deamidated gliadin peptides in blood (time frame: Blood samples were drawn once weekly at day 7, 14, 21, 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06005376, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2023.