<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/NCT04493944</url>
  </required_header>
  <id_info>
    <org_study_id>2020-016/11-02-2020</org_study_id>
    <nct_id>NCT04493944</nct_id>
  </id_info>
  <brief_title>Edible Seaweeds and Health: Quality Biomarkers to Support Consumer Acceptance</brief_title>
  <acronym>(CuisiAlg)</acronym>
  <official_title>Edible Seaweeds and Health: Quality Biomarkers to Support Consumer Acceptance</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Laval University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Quebec Maritime Network (Odyssee Saint-Laurent)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Laval University</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>
      Seaweeds have been part of the diet of Asian countries for thousands of years, but&#xD;
      consumption by Quebecers remains unfamiliar. Because of their rich nutrients content and&#xD;
      unique bioactive compounds, seaweeds have a great dietary potential. The overall objective of&#xD;
      the project is to determine the potential for sustainable local exploitation of St. Lawrence&#xD;
      seaweeds by assessing their quality under growing conditions and following processing, and to&#xD;
      use them as a basis for culinary innovations for both industry and consumers. Our specific&#xD;
      objectives are as follows:&#xD;
&#xD;
        1. To assess the impact of environmental factors on the specific profile of biomarkers of&#xD;
           nutritional quality and health potential of harvested or cultivated seaweed;&#xD;
&#xD;
        2. To determine the impact of processing on the profile of biomarkers of nutritional&#xD;
           quality and health potential of harvested and cultivated seaweed;&#xD;
&#xD;
        3. To study changes in dietary attitudes and behaviours through a culinary workshop&#xD;
           promoting the acceptance of seaweeds and their appropriation as an ingredient by&#xD;
           consumers.&#xD;
&#xD;
      The application for ethical approval and this trial registration applies only to Specific&#xD;
      Objective 3.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      For recruitment purposes, adults interested in cooking and consuming Quebec seaweeds will be&#xD;
      randomly assigned to an experimental group (n=16 x 3 groups, ingredients, recipes and a&#xD;
      culinary workshop) or a control group (n=16 x 3 groups, ingredients and recipes). Online&#xD;
      questionnaires will be administered via the secure platform of INAF (FANI) at the beginning&#xD;
      and the end of the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 1, 2020</start_date>
  <completion_date type="Anticipated">July 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 31, 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>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cooking and food-preparation practices with seaweeds</measure>
    <time_frame>2 months</time_frame>
    <description>To evaluate the impact of the culinary workshop on cooking practices of participants (self-efficacy, food attitude, food structure). Will be conducted at baseline and at the end of the study.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Consumption of seaweeds</measure>
    <time_frame>2 months</time_frame>
    <description>To evaluate the impact of the culinary workshop on consumption of seaweeds by participants. Will be conducted at baseline and at the end of the study.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">96</enrollment>
  <condition>Food Habits</condition>
  <condition>Self Efficacy</condition>
  <arm_group>
    <arm_group_label>Intervention group (with culinary workshop)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This group will be composed of participants that will answer online questionnaires before and after the study, and will participate in a culinary workshop with a chef (3 hours).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group (without culinary workshop)</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>This group will be composed of participants that will answer online questionnaires before and after the study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Culinary workshop</intervention_name>
    <description>A 3-hour culinary workshop will be led by a chef. The aim of this workshop will be to develop participants' culinary skills related to the preparation and consumption of recipes based on seaweeds, through various practical activities in the kitchen (starter, main course, dessert). An evaluation questionnaire will be completed at the end of the workshop.</description>
    <arm_group_label>Intervention group (with culinary workshop)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  be interested in cooking and consuming Quebec seaweeds in various forms&#xD;
&#xD;
          -  be available to fill out online questionnaires and perhaps participate in a culinary&#xD;
             workshop in Quebec City&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  have allergies and dietary restrictions&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Veronique Provencher, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>co-investigator, responsible for Specific Objective 3</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Veronique Provencher, PhD</last_name>
    <phone>418-656-2131</phone>
    <phone_ext>404607</phone_ext>
    <email>veronique.provencher@fsaa.ulaval.ca</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Lucie Beaulieu, PhD</last_name>
    <phone>418-656-2131</phone>
    <phone_ext>404767</phone_ext>
    <email>lucie.beaulieu@fsaa.ulaval.ca</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Institue of Nutrition and Functional Foods (INAF)</name>
      <address>
        <city>Quebec city</city>
        <state>Quebec</state>
        <zip>G1V 0A6</zip>
        <country>Canada</country>
      </address>
    </facility>
    <contact>
      <last_name>Veronique Provencher, PhD</last_name>
      <phone>418-656-2131</phone>
      <phone_ext>404607</phone_ext>
      <email>veronique.provencher@fsaa.ulaval.ca</email>
    </contact>
    <contact_backup>
      <last_name>Mylene Turcotte, MSc</last_name>
      <phone>418-656-2131</phone>
      <phone_ext>404031</phone_ext>
      <email>mylene.turcotte@fsaa.ulaval.ca</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 28, 2020</study_first_submitted>
  <study_first_submitted_qc>July 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 30, 2020</study_first_posted>
  <last_update_submitted>July 28, 2020</last_update_submitted>
  <last_update_submitted_qc>July 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 30, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Seaweeds, Food skills, Self Efficacy</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT04493944
org study id: 2020-016/11-02-2020
nct id: NCT04493944
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Seaweeds have been part of the diet of Asian countries for thousands of years, but
      consumption by Quebecers remains unfamiliar. Because of their rich nutrients content and
      unique bioactive compounds, seaweeds have a great dietary potential. The overall objective of
      the project is to determine the potential for sustainable local exploitation of St. Lawrence
      seaweeds by assessing their quality under growing conditions and following processing, and to
      use them as a basis for culinary innovations for both industry and consumers. Our specific
      objectives are as follows:

        1. To assess the impact of environmental factors on the specific profile of biomarkers of
           nutritional quality and health potential of harvested or cultivated seaweed;

        2. To determine the impact of processing on the profile of biomarkers of nutritional
           quality and health potential of harvested and cultivated seaweed;

        3. To study changes in dietary attitudes and behaviours through a culinary workshop
           promoting the acceptance of seaweeds and their appropriation as an ingredient by
           consumers.

      The application for ethical approval and this trial registration applies only to Specific
      Objective 3.
For recruitment purposes, adults interested in cooking and consuming Quebec seaweeds will be
      randomly assigned to an experimental group (n=16 x 3 groups, ingredients, recipes and a
      culinary workshop) or a control group (n=16 x 3 groups, ingredients and recipes). Online
      questionnaires will be administered via the secure platform of INAF (FANI) at the beginning
      and the end of the study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Cooking and food-preparation practices with seaweeds
time frame: 2 months
description: To evaluate the impact of the culinary workshop on cooking practices of participants (self-efficacy, food attitude, food structure). Will be conducted at baseline and at the end of the study.
measure: Consumption of seaweeds
time frame: 2 months
description: To evaluate the impact of the culinary workshop on consumption of seaweeds by participants. Will be conducted at baseline and at the end of the study.
arm group label: Intervention group (with culinary workshop)
arm group type: Experimental
description: This group will be composed of participants that will answer online questionnaires before and after the study, and will participate in a culinary workshop with a chef (3 hours).
arm group label: Control group (without culinary workshop)
arm group type: No Intervention
description: This group will be composed of participants that will answer online questionnaires before and after the study.
intervention type: Behavioral
intervention name: Culinary workshop
description: A 3-hour culinary workshop will be led by a chef. The aim of this workshop will be to develop participants' culinary skills related to the preparation and consumption of recipes based on seaweeds, through various practical activities in the kitchen (starter, main course, dessert). An evaluation questionnaire will be completed at the end of the workshop.
arm group label: Intervention group (with culinary workshop)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Veronique Provencher, PhD
role: Principal Investigator
affiliation: co-investigator, responsible for Specific Objective 3
last name: Veronique Provencher, PhD
phone: 418-656-2131
phone ext: 404607
email: veronique.provencher@fsaa.ulaval.ca
last name: Lucie Beaulieu, PhD
phone: 418-656-2131
phone ext: 404767
email: lucie.beaulieu@fsaa.ulaval.ca
facility: 
contact: 
contact backup: 
country: Canada
responsible party type: Sponsor