xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06005376</url>
    </required_header>
    <id_info>
      <org_study_id>2019F004</org_study_id>
      <nct_id>NCT06005376</nct_id>
    </id_info>
    <brief_title>Development of a Celiac Safe Food Additive</brief_title>
    <official_title>Development of a Celiac Safe Food Additive: An Intervention Study in Healthy Volunteers</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Chalmers University of Technology</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Gothia Forum - Center for Clinical Trial</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Sahlgrenska University Hospital, Sweden</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Chalmers University of Technology</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this clinical trial was to investigate if intestinal deamidation of gliadin from&#xD;
        wheat bread could be hindered by adding a E304i/zinc additive. The study was a randomized&#xD;
        double-blind 4-week crossover intervention in 20 healthy volunteers in which the participants&#xD;
        ingested 2 bread rolls a day during the intervention weeks.&#xD;
  &#xD;
        The question it aimed to answer was if there was a difference in blood levels of deamidated&#xD;
        gliadin peptides after ingestion of the reference wheat bread compared with the wheat bread&#xD;
        containing the food additive.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">July 29, 2020</start_date>
    <completion_date type="Actual">November 2, 2020</completion_date>
    <primary_completion_date type="Actual">November 2, 2020</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Crossover Assignment</intervention_model>
      <intervention_model_description>Randomised double-blind crossover intervention</intervention_model_description>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>Double (Participant, Care Provider)</masking>
      <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.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Levels of deamidated gliadin peptides in blood</measure>
      <time_frame>Blood samples were drawn once weekly at day 7, 14, 21, 28</time_frame>
      <description>Deamidated gliadin peptides in blood measured by ELISA using an antibody towards deamidated gliadin peptides</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">20</enrollment>
    <condition>Gluten Intolerance</condition>
    <arm_group>
      <arm_group_label>No additive</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>This arm was served 2 reference wheat bread rolls (a 40 g) a day.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>E304i/zinc additive</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>This arm was served 2 wheat bread rolls (a 40 g) a day containing a E304i/zinc additive.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Breakfast rolls consisting of wheat flour with and without a E304i/zinc additive</intervention_name>
      <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.</description>
      <arm_group_label>E304i/zinc additive</arm_group_label>
      <arm_group_label>No additive</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Signed informed consent&#xD;
  &#xD;
            -  Body mass index between 18.5 to 32&#xD;
  &#xD;
            -  Age between 18-50 years&#xD;
  &#xD;
            -  No tobacco use&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Celiac disease and other diagnosed enteropathies&#xD;
  &#xD;
            -  Gluten-free diet&#xD;
  &#xD;
            -  Dietary supplementation (minerals (calcium, zinc, vitamin D) and proteolytic enzymes,&#xD;
               probiotics)&#xD;
  &#xD;
            -  Pregnancy or lactation&#xD;
  &#xD;
            -  Lack of suitability for participation in the study, for any reason, as judged by the&#xD;
               medical doctor or the project PI.&#xD;
  &#xD;
            -  Withdrawn consent: Participant withdraws consent.&#xD;
  &#xD;
            -  Non-compliance: Participant fails repeatedly to comply with study protocol (diet,&#xD;
               study visits and provide samples)&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>50 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Nathalie Scheers</last_name>
      <role>Principal Investigator</role>
      <affiliation>Chalmers University of Technology, Dept of Life Sciences, Gothenburg 412 96, Sweden</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Chalmers University of Technology</name>
        <address>
          <city>Gothenburg</city>
          <zip>41296</zip>
          <country>Sweden</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Sweden</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 8, 2023</study_first_submitted>
    <study_first_submitted_qc>August 17, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 22, 2023</study_first_posted>
    <last_update_submitted>August 17, 2023</last_update_submitted>
    <last_update_submitted_qc>August 17, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 22, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Chalmers University of Technology</investigator_affiliation>
      <investigator_full_name>Nathalie Scheers</investigator_full_name>
      <investigator_title>Associate professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Celiac Disease</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_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_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_time_frame>As soon as published, no time limit</ipd_time_frame>
      <ipd_access_criteria>The study will be published in an open access journal</ipd_access_criteria>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06005376
  org study id: 2019F004
  nct id: NCT06005376
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  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.
  allocation: Randomized
  intervention model: Crossover Assignment
  intervention model description: Randomised double-blind crossover intervention
  primary purpose: Supportive Care
  masking: Double (Participant, Care 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.
  measure: Levels of deamidated gliadin peptides in blood
  time frame: Blood samples were drawn once weekly at day 7, 14, 21, 28
  description: Deamidated gliadin peptides in blood measured by ELISA using an antibody towards deamidated gliadin peptides
  arm group label: No additive
  arm group type: Active Comparator
  description: This arm was served 2 reference wheat bread rolls (a 40 g) a day.
  arm group label: E304i/zinc additive
  arm group type: Experimental
  description: This arm was served 2 wheat bread rolls (a 40 g) a day containing a E304i/zinc additive.
  intervention type: Other
  intervention name: Breakfast rolls consisting of wheat flour with and without a E304i/zinc additive
  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.
  arm group label: E304i/zinc additive
  arm group label: No additive
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 50 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Nathalie Scheers
  role: Principal Investigator
  affiliation: Chalmers University of Technology, Dept of Life Sciences, Gothenburg 412 96, Sweden
  facility: 
  country: Sweden
  responsible party type: Principal Investigator
  investigator affiliation: Chalmers University of Technology
  investigator full name: Nathalie Scheers
  investigator title: Associate professor
  mesh term: Celiac Disease
  sharing ipd: Yes
  ipd 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 info type: Study Protocol
  ipd time frame: As soon as published, no time limit
  ipd access criteria: The study will be published in an open access journal