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/NCT05976633</url>
    </required_header>
    <id_info>
      <org_study_id>HS25900 (B2023:033)</org_study_id>
      <nct_id>NCT05976633</nct_id>
    </id_info>
    <brief_title>Glycemic Response to Wild Rice and Wild Rice Blends in Humans Study</brief_title>
    <acronym>EFGW</acronym>
    <official_title>Evaluating the Factors That Influence Glycemic Response to Wild Rice and Wild Rice Blends in Humans (EFGW) Study.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Manitoba</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Mitacs</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>University of Manitoba</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 is to test the effects of wild rice and wild rice blends&#xD;
        compared to other rice on glycemic control and evaluating factors that influence glycemic&#xD;
        response to wild rice in healthy individuals. The main questions aim to answer:&#xD;
  &#xD;
          1. Is there an effect of wild rice on blends on glycemic control and response?&#xD;
  &#xD;
          2. Does cooking wild rice via stovetop or microwave change its glycemic response?&#xD;
  &#xD;
          3. Is the wild rice blend product palatable?&#xD;
  &#xD;
          4. What is the subjective appetite when consuming the treatment?&#xD;
  &#xD;
        Participants will:&#xD;
  &#xD;
          -  consent to attend 5 study visits being 2.5 hours each&#xD;
  &#xD;
          -  come to each visit fasted for at least 10-12 hours.&#xD;
  &#xD;
          -  complete a Motivation to Eat VAS following each blood measure&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study will be a crossover randomized trial consisting of 5 sessions. The wild rice&#xD;
        products will be provided by the Myera group.&#xD;
  &#xD;
        Participants will fast and arrive at the Richardson Centre for Food Technology and Research&#xD;
        (RCFTR) between 7am - 11am on the session day. They will be provided either of the study&#xD;
        treatments based on randomization sequence. Baseline blood glucose (0 min) will be measured&#xD;
        twice via finger stick blood sample right before their first bite of the study product, and&#xD;
        at 15, 30, 45, 60, 90 and 120 mins after baseline in duplicate. VAS will be completed&#xD;
        following consumption of the treatments to measure palatability and subjective appetite at&#xD;
        baseline (0 min), and at 15, 30, 45, 60, 90, and 120 minute time points.&#xD;
  &#xD;
        The primary objective is to test the effects of wild rice and wild rice blends compared to&#xD;
        other rice on glycemic control and evaluating factors that influence glycemic response to&#xD;
        wild rice in humans performed via the finger stick blood glucose that will be measured&#xD;
        throughout each session as outlined above. Secondly, to test whether wild rice glycemic&#xD;
        response is affected based on cooking method.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">August 10, 2023</start_date>
    <completion_date type="Anticipated">March 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 30, 2023</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>crossover randomized clinical trial.</intervention_model_description>
      <primary_purpose>Basic Science</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Glycemic response</measure>
      <time_frame>Capillary blood glucose will be measured at 0 (baseline) and then 15, 30, 45, 60, 90 and 120 minutes after the treatment has been consumed..</time_frame>
      <description>Finger stick blood glucose will be taken throughout each session.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Palatability of rice products</measure>
      <time_frame>VAS measurements at 0 (baseline) and then 15, 30, 45, 60, 90 and 120 minutes</time_frame>
      <description>Visual Analogue Scale (VAS) assessment following consumption of the treatment</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Subjective appetite</measure>
      <time_frame>VAS measurements at 0 (baseline) and then 15, 30, 45, 60, 90 and 120 minutes.</time_frame>
      <description>Visual Analogue Scale (VAS) assessment following consumption of the treatment measurement.</description>
    </secondary_outcome>
    <number_of_arms>5</number_of_arms>
    <enrollment type="Anticipated">20</enrollment>
    <condition>Blood Glucose</condition>
    <arm_group>
      <arm_group_label>Consumption of 1 of 3 rice products</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>This arm will provide 1 of the 3 randomly assigned rice products to the participant and there will be a minimum of three days separating each visit.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Consumption of 2 of 3 rice products</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>This arm will provide the consumption of the second randomly assigned rice product. There will be a minimum of three days separating each visit.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Consumption of 3 of 3 rice products</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>This arm will provide the third consumption of the randomly assigned rice product. There will be a minimum of three days separating each visit.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Consumption of the control rice product</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>This arm will provide the white rice control product.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Consumption of 1 of 3 rice products with different preparation method</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>This arm will provide the blends product via a different cooking method (microwave).</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Whole white rice (control)</intervention_name>
      <description>One serving size (140g cooked on stovetop) of whole white rice will be provided. Cooking time will be consistently maintained throughout.</description>
      <arm_group_label>Consumption of the control rice product</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Whole brown rice</intervention_name>
      <description>One serving size (140g cooked on stovetop) of whole brown rice will be provided. Cooking time will be consistently maintained throughout.</description>
      <arm_group_label>Consumption of 3 of 3 rice products</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Whole wild rice</intervention_name>
      <description>One serving size (140g cooked on stovetop) of whole wild rice will be provided. Cooking time will be consistently maintained throughout.</description>
      <arm_group_label>Consumption of 2 of 3 rice products</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>15% Wild rice and 85% Brown rice blend - Stovetop</intervention_name>
      <description>One serving size (140g cooked on stovetop) of 15% wild rice and 85% brown rice blend (Myera) will be provided. Cooking time will be consistently maintained throughout.</description>
      <arm_group_label>Consumption of 1 of 3 rice products</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>15% Wild rice and 85% Brown rice blend - Microwaved</intervention_name>
      <description>One serving size (140g cooked in microwave) of 15% wild rice and 85% brown rice blend (Myera) will be provided. Cooking time will be consistently maintained throughout.</description>
      <arm_group_label>Consumption of 1 of 3 rice products with different preparation method</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Participant is willing and able to give informed consent for participation in the&#xD;
               trial&#xD;
  &#xD;
            -  Male or female between 18-50 years old&#xD;
  &#xD;
            -  BMI range in between 18.9-29.9 kg/m2&#xD;
  &#xD;
            -  Fasting glucose &lt;5.6 mmol/L&#xD;
  &#xD;
            -  Usually eat breakfast&#xD;
  &#xD;
            -  Participant must receive at least two doses of COVID-19 vaccine that have been&#xD;
               recognized by Winnipeg Regional Health Authorities.&#xD;
  &#xD;
            -  In the Investigator's opinion is able and willing to comply with all trial&#xD;
               requirements&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Fasting glucose ≥ 5.6 mmol/L or &lt;3.5 mmol/L&#xD;
  &#xD;
            -  Female participant who is pregnant, lactating or planning pregnancy during the course&#xD;
               of the trial&#xD;
  &#xD;
            -  Participants who indicate that they could not finish study treatments within 10&#xD;
               minutes&#xD;
  &#xD;
            -  Use of medication or supplements that may influence carbohydrate metabolism,&#xD;
               including, not limit to adrenergic blockers, diuretics, thiazolidinediones, metformin&#xD;
               and systemic corticosteroids within 4 weeks of screening visit&#xD;
  &#xD;
            -  History of disordered eating, AIDS, hepatitis, a history of clinically important&#xD;
               endocrine (including Type I and Type II diabetes mellitus), cardiovascular (including&#xD;
               but not limit to atherosclerotic disease, history of myocardial infarction, peripheral&#xD;
               arterial disease, stroke), pulmonary, biliary or GI disorders&#xD;
  &#xD;
            -  Intolerance or allergic reaction to rice&#xD;
  &#xD;
            -  Existing restrictive dietary habits (such a vegan, low carbohydrate/keto)&#xD;
  &#xD;
            -  History of hypertension&#xD;
  &#xD;
            -  History of cancer within the last two years (except for non-melanoma skin cancer)&#xD;
  &#xD;
            -  Recent history (within 12 month of screening) or current consumption of &gt;14 drinks per&#xD;
               week, (1 drink = 12oz of beer, 5oz of wine or 1.5oz distilled spirits)&#xD;
  &#xD;
            -  Body weight change over 3.5kg for the past 3 months&#xD;
  &#xD;
            -  Participants who have participated in another research trial involving an&#xD;
               investigational product in the past 12 weeks&#xD;
  &#xD;
            -  Had significant physical trauma or major surgery in the past 3 month or had trauma or&#xD;
               major surgery in the past 3 months&#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>Dylan MacKay, PHD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Manitoba</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Dylan MacKay, PHD</last_name>
      <phone>204-272-3119</phone>
      <email>dylan.mackay@umanitoba.ca</email>
    </overall_contact>
    <location>
      <facility>
        <name>Richardson Center for Food Technology and Research</name>
        <address>
          <city>Winnipeg</city>
          <state>Manitoba</state>
          <zip>R3T 2N2</zip>
          <country>Canada</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Rebecca Mollard, PhD</last_name>
        <phone>204-631-3834</phone>
        <email>rmollard@sogh.mb.ca</email>
      </contact>
      <investigator>
        <last_name>Dylan MacKay, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Navdeep Tangri, MD, PHD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Rebecca Mollard, PhD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Canada</country>
    </location_countries>
    <verification_date>April 2023</verification_date>
    <study_first_submitted>July 17, 2023</study_first_submitted>
    <study_first_submitted_qc>August 3, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 4, 2023</study_first_posted>
    <last_update_submitted>August 3, 2023</last_update_submitted>
    <last_update_submitted_qc>August 3, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 4, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>glycemic response</keyword>
    <keyword>glycemic control</keyword>
    <keyword>rice</keyword>
    <!-- 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/NCT05976633
  org study id: HS25900 (B2023:033)
  nct id: NCT05976633
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this clinical trial is to test the effects of wild rice and wild rice blends
        compared to other rice on glycemic control and evaluating factors that influence glycemic
        response to wild rice in healthy individuals. The main questions aim to answer:
  
          1. Is there an effect of wild rice on blends on glycemic control and response?
  
          2. Does cooking wild rice via stovetop or microwave change its glycemic response?
  
          3. Is the wild rice blend product palatable?
  
          4. What is the subjective appetite when consuming the treatment?
  
        Participants will:
  
          -  consent to attend 5 study visits being 2.5 hours each
  
          -  come to each visit fasted for at least 10-12 hours.
  
          -  complete a Motivation to Eat VAS following each blood measure
  This study will be a crossover randomized trial consisting of 5 sessions. The wild rice
        products will be provided by the Myera group.
  
        Participants will fast and arrive at the Richardson Centre for Food Technology and Research
        (RCFTR) between 7am - 11am on the session day. They will be provided either of the study
        treatments based on randomization sequence. Baseline blood glucose (0 min) will be measured
        twice via finger stick blood sample right before their first bite of the study product, and
        at 15, 30, 45, 60, 90 and 120 mins after baseline in duplicate. VAS will be completed
        following consumption of the treatments to measure palatability and subjective appetite at
        baseline (0 min), and at 15, 30, 45, 60, 90, and 120 minute time points.
  
        The primary objective is to test the effects of wild rice and wild rice blends compared to
        other rice on glycemic control and evaluating factors that influence glycemic response to
        wild rice in humans performed via the finger stick blood glucose that will be measured
        throughout each session as outlined above. Secondly, to test whether wild rice glycemic
        response is affected based on cooking method.
  allocation: Randomized
  intervention model: Crossover Assignment
  intervention model description: crossover randomized clinical trial.
  primary purpose: Basic Science
  masking: Single (Participant)
  measure: Glycemic response
  time frame: Capillary blood glucose will be measured at 0 (baseline) and then 15, 30, 45, 60, 90 and 120 minutes after the treatment has been consumed..
  description: Finger stick blood glucose will be taken throughout each session.
  measure: Palatability of rice products
  time frame: VAS measurements at 0 (baseline) and then 15, 30, 45, 60, 90 and 120 minutes
  description: Visual Analogue Scale (VAS) assessment following consumption of the treatment
  measure: Subjective appetite
  time frame: VAS measurements at 0 (baseline) and then 15, 30, 45, 60, 90 and 120 minutes.
  description: Visual Analogue Scale (VAS) assessment following consumption of the treatment measurement.
  arm group label: Consumption of 1 of 3 rice products
  arm group type: Experimental
  description: This arm will provide 1 of the 3 randomly assigned rice products to the participant and there will be a minimum of three days separating each visit.
  arm group label: Consumption of 2 of 3 rice products
  arm group type: Experimental
  description: This arm will provide the consumption of the second randomly assigned rice product. There will be a minimum of three days separating each visit.
  arm group label: Consumption of 3 of 3 rice products
  arm group type: Experimental
  description: This arm will provide the third consumption of the randomly assigned rice product. There will be a minimum of three days separating each visit.
  arm group label: Consumption of the control rice product
  arm group type: Active Comparator
  description: This arm will provide the white rice control product.
  arm group label: Consumption of 1 of 3 rice products with different preparation method
  arm group type: Experimental
  description: This arm will provide the blends product via a different cooking method (microwave).
  intervention type: Other
  intervention name: Whole white rice (control)
  description: One serving size (140g cooked on stovetop) of whole white rice will be provided. Cooking time will be consistently maintained throughout.
  arm group label: Consumption of the control rice product
  intervention type: Other
  intervention name: Whole brown rice
  description: One serving size (140g cooked on stovetop) of whole brown rice will be provided. Cooking time will be consistently maintained throughout.
  arm group label: Consumption of 3 of 3 rice products
  intervention type: Other
  intervention name: Whole wild rice
  description: One serving size (140g cooked on stovetop) of whole wild rice will be provided. Cooking time will be consistently maintained throughout.
  arm group label: Consumption of 2 of 3 rice products
  intervention type: Other
  intervention name: 15% Wild rice and 85% Brown rice blend - Stovetop
  description: One serving size (140g cooked on stovetop) of 15% wild rice and 85% brown rice blend (Myera) will be provided. Cooking time will be consistently maintained throughout.
  arm group label: Consumption of 1 of 3 rice products
  intervention type: Other
  intervention name: 15% Wild rice and 85% Brown rice blend - Microwaved
  description: One serving size (140g cooked in microwave) of 15% wild rice and 85% brown rice blend (Myera) will be provided. Cooking time will be consistently maintained throughout.
  arm group label: Consumption of 1 of 3 rice products with different preparation method
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 50 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Dylan MacKay, PHD
  role: Principal Investigator
  affiliation: University of Manitoba
  last name: Dylan MacKay, PHD
  phone: 204-272-3119
  email: dylan.mackay@umanitoba.ca
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  investigator: 
  investigator: 
  country: Canada
  responsible party type: Sponsor