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/NCT06005415</url>
    </required_header>
    <id_info>
      <org_study_id>S67376</org_study_id>
      <nct_id>NCT06005415</nct_id>
    </id_info>
    <brief_title>Glycemic Response to an Innovative Cookie to Promote Human Health</brief_title>
    <acronym>GRINCH</acronym>
    <official_title>Glycemic Response to an Innovative Cookie to Promote Human Health</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>KU Leuven</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>KU Leuven</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 aim of this study is to investigate whether using a coarse wheat fraction in wire-cut&#xD;
        cookie making induces a lower glycemic response in healthy subjects compared to wheat flour.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study has a double-blind, randomized, cross-over design. During each of the two study&#xD;
        visits, healthy participants will consume a standard portion of cookies. One cookie&#xD;
        formulation will present a large amount of coarse wheat fraction, while the other formulation&#xD;
        will include only wheat flour and will serve as a control. Blood glucose measurements will be&#xD;
        taken postprandially at regular time points. Gastric emptying rate and oral processing&#xD;
        behavior will be also object of study.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">September 5, 2023</start_date>
    <completion_date type="Anticipated">November 30, 2023</completion_date>
    <primary_completion_date type="Anticipated">November 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>
      <primary_purpose>Basic Science</primary_purpose>
      <masking>Double (Participant, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Glucose response</measure>
      <time_frame>10, 5 minute before and 10, 20, 30, 45, 60, 75, 90, 120, 150 and 180 minutes after consumption of test meal, both test day 1 and 2</time_frame>
      <description>Incremental area under the curve of blood glucose concentration (mM) after wheat-based wire-cut cookie consumption, measured through blood samples collected via finger-prick before eating (i.e. 10 and 5 minutes before ingestion) and at respective time points after consumption of test meal (i.e. 10, 20, 30, 45, 60, 75, 90, 120, 150 and 180 minutes).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Peak rise of blood glucose</measure>
      <time_frame>10, 5 minute before and 10, 20, 30, 45, 60, 75, 90, 120, 150 and 180 minutes after consumption of test meal, both test day 1 and 2</time_frame>
      <description>Difference between the highest postprandial blood glucose concentration and the baseline (expressed in mM), measured through blood samples collected via finger-prick before eating (i.e. 10 and 5 minutes before ingestion) and at respective time points after consumption of test meal (i.e. 10, 20, 30, 45, 60, 75, 90, 120, 150 and 180 minutes).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Gastric emptying rate</measure>
      <time_frame>0, 10, 20, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180 minutes after consumption of test meal, on test day 1</time_frame>
      <description>Measured through 13C-octanoic acid breath samples collected before eating (i.e. 0 minute) and at respective time points after consumption of test meal (i.e. 10, 20, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180 minutes).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Gastric emptying rate</measure>
      <time_frame>0, 10, 20, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180 minutes after consumption of test meal, on test day 2</time_frame>
      <description>Measured through 13C-octanoic acid breath samples collected before eating (i.e. 0 minute) and at respective time points after consumption of test meal (i.e. 10, 20, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180 minutes).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Oral processing behavior (exposure time)</measure>
      <time_frame>During test meal consumption, up to 10 minutes, on test day 1</time_frame>
      <description>Participants will be video-recorded to analyze oral processing behavior of the test meal. Number of bites, chews, swallows and time in mouth (s) will be annotated to derive total oral exposure time (s).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Oral processing behavior (exposure time)</measure>
      <time_frame>During test meal consumption, up to 10 minutes, on test day 2</time_frame>
      <description>Participants will be video-recorded to analyze oral processing behavior of the test meal. Number of bites, chews, swallows and time in mouth (s) will be annotated to derive total oral exposure time (s).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Oral processing behavior (average bite size)</measure>
      <time_frame>During test meal consumption, up to 10 minutes, on test day 1</time_frame>
      <description>Participants will be video-recorded to analyze oral processing behavior of the test meal. Number of bites, chews, swallows and time in mouth (s) will be annotated to derive total average bite size (g per bite).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Oral processing behavior (average bite size)</measure>
      <time_frame>During test meal consumption, up to 10 minutes, on test day 2</time_frame>
      <description>Participants will be video-recorded to analyze oral processing behavior of the test meal. Number of bites, chews, swallows and time in mouth (s) will be annotated to derive total average bite size (g per bite).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Oral processing behavior (average chews per bite)</measure>
      <time_frame>During test meal consumption, up to 10 minutes, on test day 1</time_frame>
      <description>Participants will be video-recorded to analyze oral processing behavior of the test meal. Number of bites, chews, swallows and time in mouth (s) will be annotated to derive total average chews per bite.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Oral processing behavior (average chews per bite)</measure>
      <time_frame>During test meal consumption, up to 10 minutes, on test day 2</time_frame>
      <description>Participants will be video-recorded to analyze oral processing behavior of the test meal. Number of bites, chews, swallows and time in mouth (s) will be annotated to derive total average chews per bite.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Oral processing behavior (eating rate)</measure>
      <time_frame>During test meal consumption, up to 10 minutes, on test day 1</time_frame>
      <description>Participants will be video-recorded to analyze oral processing behavior of the test meal. Number of bites, chews, swallows and time in mouth (s) will be annotated to derive total eating rate (g per minute).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Oral processing behavior (eating rate)</measure>
      <time_frame>During test meal consumption, up to 10 minutes, on test day 2</time_frame>
      <description>Participants will be video-recorded to analyze oral processing behavior of the test meal. Number of bites, chews, swallows and time in mouth (s) will be annotated to derive total eating rate (g per minute).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Oral processing behavior (energy intake rate)</measure>
      <time_frame>During test meal consumption, up to 10 minutes, on test day 1</time_frame>
      <description>Participants will be video-recorded to analyze oral processing behavior of the test meal. Number of bites, chews, swallows and time in mouth (s) will be annotated to derive total energy intake rate (kcal per minute).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Oral processing behavior (energy intake rate)</measure>
      <time_frame>During test meal consumption, up to 10 minutes, on test day 2</time_frame>
      <description>Participants will be video-recorded to analyze oral processing behavior of the test meal. Number of bites, chews, swallows and time in mouth (s) will be annotated to derive total energy intake rate (kcal per minute).</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">52</enrollment>
    <condition>Postprandial Glycemic Responses</condition>
    <arm_group>
      <arm_group_label>Test cookie</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Wire-cut cookie portion (85 g) containing wheat flour, coarse wheat semolina, sucrose, vegetable shortening, water, sodium chloride, sodium bicarbonate and sodium octanoate.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control cookie</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Wire-cut cookie portion (85 g) containing wheat flour, wheat bran, sucrose, vegetable shortening, water, sodium chloride, sodium bicarbonate and sodium octanoate.</description>
    </arm_group>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Wire-cut cookie</intervention_name>
      <description>Investigation of the impact of wheat particle size on the postprandial glycemic response, gastric emptying and oral processing behavior after consumption of wire-cut cookies.</description>
      <arm_group_label>Control cookie</arm_group_label>
      <arm_group_label>Test cookie</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Body mass index (BMI) range 18.5 - 25.0 kg/m2 at screening visit&#xD;
  &#xD;
            -  Fasting whole blood glucose values &lt; 6.3 mmol/L&#xD;
  &#xD;
            -  Regular diet with 3 meals a day (at least 5 times a week)&#xD;
  &#xD;
            -  Absence of health conditions that would prevent fulfillment of study requirements as&#xD;
               judged by the Investigators on the basis of medical history&#xD;
  &#xD;
            -  Willingness to maintain habitual diet, physical activity pattern, and body weight&#xD;
               throughout the trial&#xD;
  &#xD;
            -  Willingness to abstain from alcohol consumption and to avoid vigorous physical&#xD;
               activity for 24 h prior to study visits&#xD;
  &#xD;
            -  Adequate level of understanding spoken and written English&#xD;
  &#xD;
            -  Willingness to report lifestyle factors such as level of physical activity and&#xD;
               perceived psychological stress&#xD;
  &#xD;
            -  Willingness to provide informed consent to participate in the study&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Failure to meet any one of the inclusion criteria&#xD;
  &#xD;
            -  Recent participation in any clinical trial (&lt; 90 days)&#xD;
  &#xD;
            -  Pregnant or lactating or wishing to become pregnant in the period of the study&#xD;
  &#xD;
            -  Known history of AIDS, hepatitis, diabetes mellitus (Type I and II), cardiovascular&#xD;
               disease, any pathology (or recent surgical event) of the gastrointestinal system or&#xD;
               any current metabolic or endocrine disease&#xD;
  &#xD;
            -  Alcohol consumption of &gt; 14 standard drinks for women and &gt; 21 standard drinks for men&#xD;
               per week&#xD;
  &#xD;
            -  Currently smoking (have smoked in the last 28 days) or willingness to smoke during the&#xD;
               study period&#xD;
  &#xD;
            -  Celiac disease or gluten intolerance&#xD;
  &#xD;
            -  Use of medications known to influence carbohydrate metabolism, including, but not&#xD;
               limited to adrenergic blockers, diuretics, thiazolidinediones, metformin and systemic&#xD;
               corticosteroids the last 4 weeks before the screening visit&#xD;
  &#xD;
            -  Use of antibiotics during the last three months&#xD;
  &#xD;
            -  Reported slimming or medically prescribed diet&#xD;
  &#xD;
            -  Unwillingness or inability to comply with the experimental procedures and to follow&#xD;
               the safety guidelines&#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>Kristin Verbeke, Prof.</last_name>
      <role>Principal Investigator</role>
      <affiliation>KU Leuven</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Kristin Verbeke, Prof.</last_name>
      <phone>+3216330150</phone>
      <email>kristin.verbeke@kuleuven.be</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Leonardo LI Mulargia, MSc</last_name>
      <phone>+32490408610</phone>
      <email>leonardo.mulargia@kuleuven.be</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>KU Leuven/UZ Leuven</name>
        <address>
          <city>Leuven</city>
          <state>Vlaams-Brabant</state>
          <zip>3000</zip>
          <country>Belgium</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Leonardo LI Mulargia, MSc</last_name>
        <phone>+32490408610</phone>
        <email>leonardo.mulargia@kuleuven.be</email>
      </contact>
      <contact_backup>
        <last_name>Kristin Verbeke, Prof.</last_name>
        <phone>+3216330150</phone>
        <email>kristin.verbeke@med.kuleuven.be</email>
      </contact_backup>
      <investigator>
        <last_name>Kristin Verbeke, Prof.</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Belgium</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 1, 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>September 5, 2023</last_update_submitted>
    <last_update_submitted_qc>September 5, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 6, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>KU Leuven</investigator_affiliation>
      <investigator_full_name>Kristin Verbeke</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <keyword>postprandial glycemic responses</keyword>
    <keyword>gastric emptying rate</keyword>
    <keyword>oral processing behavior</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </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/NCT06005415
  org study id: S67376
  nct id: NCT06005415
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The aim of this study is to investigate whether using a coarse wheat fraction in wire-cut
        cookie making induces a lower glycemic response in healthy subjects compared to wheat flour.
  This study has a double-blind, randomized, cross-over design. During each of the two study
        visits, healthy participants will consume a standard portion of cookies. One cookie
        formulation will present a large amount of coarse wheat fraction, while the other formulation
        will include only wheat flour and will serve as a control. Blood glucose measurements will be
        taken postprandially at regular time points. Gastric emptying rate and oral processing
        behavior will be also object of study.
  allocation: Randomized
  intervention model: Crossover Assignment
  primary purpose: Basic Science
  masking: Double (Participant, Investigator)
  measure: Glucose response
  time frame: 10, 5 minute before and 10, 20, 30, 45, 60, 75, 90, 120, 150 and 180 minutes after consumption of test meal, both test day 1 and 2
  description: Incremental area under the curve of blood glucose concentration (mM) after wheat-based wire-cut cookie consumption, measured through blood samples collected via finger-prick before eating (i.e. 10 and 5 minutes before ingestion) and at respective time points after consumption of test meal (i.e. 10, 20, 30, 45, 60, 75, 90, 120, 150 and 180 minutes).
  measure: Peak rise of blood glucose
  time frame: 10, 5 minute before and 10, 20, 30, 45, 60, 75, 90, 120, 150 and 180 minutes after consumption of test meal, both test day 1 and 2
  description: Difference between the highest postprandial blood glucose concentration and the baseline (expressed in mM), measured through blood samples collected via finger-prick before eating (i.e. 10 and 5 minutes before ingestion) and at respective time points after consumption of test meal (i.e. 10, 20, 30, 45, 60, 75, 90, 120, 150 and 180 minutes).
  measure: Gastric emptying rate
  time frame: 0, 10, 20, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180 minutes after consumption of test meal, on test day 1
  description: Measured through 13C-octanoic acid breath samples collected before eating (i.e. 0 minute) and at respective time points after consumption of test meal (i.e. 10, 20, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180 minutes).
  measure: Gastric emptying rate
  time frame: 0, 10, 20, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180 minutes after consumption of test meal, on test day 2
  description: Measured through 13C-octanoic acid breath samples collected before eating (i.e. 0 minute) and at respective time points after consumption of test meal (i.e. 10, 20, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180 minutes).
  measure: Oral processing behavior (exposure time)
  time frame: During test meal consumption, up to 10 minutes, on test day 1
  description: Participants will be video-recorded to analyze oral processing behavior of the test meal. Number of bites, chews, swallows and time in mouth (s) will be annotated to derive total oral exposure time (s).
  measure: Oral processing behavior (exposure time)
  time frame: During test meal consumption, up to 10 minutes, on test day 2
  description: Participants will be video-recorded to analyze oral processing behavior of the test meal. Number of bites, chews, swallows and time in mouth (s) will be annotated to derive total oral exposure time (s).
  measure: Oral processing behavior (average bite size)
  time frame: During test meal consumption, up to 10 minutes, on test day 1
  description: Participants will be video-recorded to analyze oral processing behavior of the test meal. Number of bites, chews, swallows and time in mouth (s) will be annotated to derive total average bite size (g per bite).
  measure: Oral processing behavior (average bite size)
  time frame: During test meal consumption, up to 10 minutes, on test day 2
  description: Participants will be video-recorded to analyze oral processing behavior of the test meal. Number of bites, chews, swallows and time in mouth (s) will be annotated to derive total average bite size (g per bite).
  measure: Oral processing behavior (average chews per bite)
  time frame: During test meal consumption, up to 10 minutes, on test day 1
  description: Participants will be video-recorded to analyze oral processing behavior of the test meal. Number of bites, chews, swallows and time in mouth (s) will be annotated to derive total average chews per bite.
  measure: Oral processing behavior (average chews per bite)
  time frame: During test meal consumption, up to 10 minutes, on test day 2
  description: Participants will be video-recorded to analyze oral processing behavior of the test meal. Number of bites, chews, swallows and time in mouth (s) will be annotated to derive total average chews per bite.
  measure: Oral processing behavior (eating rate)
  time frame: During test meal consumption, up to 10 minutes, on test day 1
  description: Participants will be video-recorded to analyze oral processing behavior of the test meal. Number of bites, chews, swallows and time in mouth (s) will be annotated to derive total eating rate (g per minute).
  measure: Oral processing behavior (eating rate)
  time frame: During test meal consumption, up to 10 minutes, on test day 2
  description: Participants will be video-recorded to analyze oral processing behavior of the test meal. Number of bites, chews, swallows and time in mouth (s) will be annotated to derive total eating rate (g per minute).
  measure: Oral processing behavior (energy intake rate)
  time frame: During test meal consumption, up to 10 minutes, on test day 1
  description: Participants will be video-recorded to analyze oral processing behavior of the test meal. Number of bites, chews, swallows and time in mouth (s) will be annotated to derive total energy intake rate (kcal per minute).
  measure: Oral processing behavior (energy intake rate)
  time frame: During test meal consumption, up to 10 minutes, on test day 2
  description: Participants will be video-recorded to analyze oral processing behavior of the test meal. Number of bites, chews, swallows and time in mouth (s) will be annotated to derive total energy intake rate (kcal per minute).
  arm group label: Test cookie
  arm group type: Active Comparator
  description: Wire-cut cookie portion (85 g) containing wheat flour, coarse wheat semolina, sucrose, vegetable shortening, water, sodium chloride, sodium bicarbonate and sodium octanoate.
  arm group label: Control cookie
  arm group type: Active Comparator
  description: Wire-cut cookie portion (85 g) containing wheat flour, wheat bran, sucrose, vegetable shortening, water, sodium chloride, sodium bicarbonate and sodium octanoate.
  intervention type: Dietary Supplement
  intervention name: Wire-cut cookie
  description: Investigation of the impact of wheat particle size on the postprandial glycemic response, gastric emptying and oral processing behavior after consumption of wire-cut cookies.
  arm group label: Control cookie
  arm group label: Test cookie
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 50 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Kristin Verbeke, Prof.
  role: Principal Investigator
  affiliation: KU Leuven
  last name: Kristin Verbeke, Prof.
  phone: +3216330150
  email: kristin.verbeke@kuleuven.be
  last name: Leonardo LI Mulargia, MSc
  phone: +32490408610
  email: leonardo.mulargia@kuleuven.be
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  country: Belgium
  responsible party type: Principal Investigator
  investigator affiliation: KU Leuven
  investigator full name: Kristin Verbeke
  investigator title: Professor
  sharing ipd: No