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/NCT05977543</url>
    </required_header>
    <id_info>
      <org_study_id>12123</org_study_id>
      <nct_id>NCT05977543</nct_id>
    </id_info>
    <brief_title>Acute Effect of Functional Crackers on Postprandial Metabolism</brief_title>
    <acronym>Crade23</acronym>
    <official_title>The Acute Effect of Functional Crackers, Enriched With Grape Seed Flour or With Barley Flour and β-glucans, on Postprandial Glycemic, Lipemic and Antioxidant Metabolism</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of the Aegean</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of the Aegean</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 interventional study was to investigate the postprandial effect of two types&#xD;
        of functional crackers, with 10% grape seed flour or 40% barley flour, enriched with&#xD;
        β-glucan, in metabolic biomarkers of healthy participants.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        A pilot cross-over, controlled, randomized and single-blinded, intervention-clinical trial&#xD;
        was carried out, in twelve healthy men and women, aged nineteen to sixty-five years, after&#xD;
        random allocation into the control, the grape and the barley interventional groups, received&#xD;
        a high-fat and high-carbohydrate meal, containing wheat flour or wheat and 10% grape seed&#xD;
        flour or wheat and 40% barley flour, enriched with β-glucan, crackers. Participants consumed&#xD;
        the same meals, allocating in cross-over order, with 1 washout week after each trial period.&#xD;
        Differences on the metabolism of postprandial serum total, High Density Lipoprotein (HDL-),&#xD;
        Low Density Lipoprotein (LDL-) cholesterol, glucose, triglycerides and uric acid levels, as&#xD;
        well as of plasma total antioxidant capacity according to Ferric Reducing Antioxidant Power&#xD;
        method, were determined between groups in fasting, thirty minutes, one and a half hour, and&#xD;
        three hours after meal intake.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">February 15, 2023</start_date>
    <completion_date type="Anticipated">October 15, 2023</completion_date>
    <primary_completion_date type="Actual">March 1, 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>On enrolment, all subjects were randomly assigned to the C: F1:F2 group (Control: Functional 1: Functional 2), to the F1: C: F2 group (Functional 1: Control: Functional 2) or to the F2: F1: C group (Functional 2: Functional 1: Control). Subjects in the C: F1:F2 group received the Control meal on the first visit, the Functional meal 1 on the second visit and the Functional meal 2 on the third visit; those in the F1:C:F2 group received the Functional meal 1 on the first visit, the Control meal on the second visit and the Functional meal 2 on the third visit while those in the F2:F1:C group received the Functional meal 2 on the first visit, the meal Functional meal 1 on the second visit and the Control meal on the third visit.</intervention_model_description>
      <primary_purpose>Other</primary_purpose>
      <masking>Single (Participant)</masking>
      <masking_description>Only investigators knew the group in which each participant were enrolled.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Glucose</measure>
      <time_frame>3 hours</time_frame>
      <description>Glucose concentration changes from baseline at 3hours</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Total Antioxidant Capacity</measure>
      <time_frame>3 hours</time_frame>
      <description>Total Antioxidant Capacity concentration changes from baseline at 3 hours</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Total cholesterol</measure>
      <time_frame>3 hours</time_frame>
      <description>Total cholesterol concentration changes from baseline at 3hours</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>High Density Lipoprotein cholesterol</measure>
      <time_frame>3 hours</time_frame>
      <description>High Density Lipoprotein concentration cholesterol changes from baseline at 3hours</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Low Density Lipoprotein cholesterol</measure>
      <time_frame>3 hours</time_frame>
      <description>Low Density Lipoprotein cholesterol concentration changes from baseline at 3hours</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Triglycerides</measure>
      <time_frame>3 hours</time_frame>
      <description>Triglycerides concentration changes from baseline at 3hours</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Uric Acid</measure>
      <time_frame>3 hours</time_frame>
      <description>Uric Acid concentration changes from baseline at 3hours</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Actual">13</enrollment>
    <condition>Healthy</condition>
    <arm_group>
      <arm_group_label>Control wheat crackers</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Volunteers consumed 80g of white bread, 30g of full fat butter and 55g of wheat flour crackers.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Grape seed flour crackers</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Volunteers consumed 80g of white bread, 30g of full fat butter and 55g of wheat flour crackers, enriched with 10% grape seed flour crackers.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Barley flour and β-glucan crackers</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Volunteers consumed 80g of white bread, 30g of full fat butter and 55g of 60% wheat flour and 40% barley flour crackers, enriched with β-glucan</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Functional crackers enriched with grape seed flour</intervention_name>
      <description>The crackers was enriched with 10% grape seed flour</description>
      <arm_group_label>Grape seed flour crackers</arm_group_label>
      <other_name>Grape seed flour crackers</other_name>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Functional crackers with 40% barley flour and enriched with β-glucans</intervention_name>
      <description>The crackers consisted of 60% wheat flour, 40% barley flour and was enriched with β-glucans.</description>
      <arm_group_label>Barley flour and β-glucan crackers</arm_group_label>
      <other_name>Barley flour crackers</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age 19-65 years&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Age over 65 years old&#xD;
  &#xD;
            -  History of chronic illness including type I and II diabetes (hemoglobin A1c-HbA1c &gt;&#xD;
               5%)&#xD;
  &#xD;
            -  Abnormal Body Mass Index (BMI) (&gt;25 kg/m2)&#xD;
  &#xD;
            -  Alcohol overconsumption (&gt;40 g alcohol/day)&#xD;
  &#xD;
            -  Abnormal hematological and biochemical profiles (cholesterol &gt; 6.8 mM, triglycerides &gt;&#xD;
               2.8 mM, glucose &gt; 6.11 mM)&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>19 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Antonios Koutelidakis, Professor</last_name>
      <role>Study Director</role>
      <affiliation>University of the Aegean</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>University of the Aegean</name>
        <address>
          <city>Myrina</city>
          <state>Limnos/Lesvos</state>
          <zip>81 400</zip>
          <country>Greece</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Greece</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 16, 2023</study_first_submitted>
    <study_first_submitted_qc>July 26, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 4, 2023</study_first_posted>
    <last_update_submitted>August 4, 2023</last_update_submitted>
    <last_update_submitted_qc>August 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>enriched with 10% grape seed flour crackers</keyword>
    <keyword>40% barley flour crackers enriched with β-glucan</keyword>
    <keyword>postprandial effect</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>There are no plans to share individual participant data for this study.</ipd_description>
    </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/NCT05977543
  org study id: 12123
  nct id: NCT05977543
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The aim of this interventional study was to investigate the postprandial effect of two types
        of functional crackers, with 10% grape seed flour or 40% barley flour, enriched with
        β-glucan, in metabolic biomarkers of healthy participants.
  A pilot cross-over, controlled, randomized and single-blinded, intervention-clinical trial
        was carried out, in twelve healthy men and women, aged nineteen to sixty-five years, after
        random allocation into the control, the grape and the barley interventional groups, received
        a high-fat and high-carbohydrate meal, containing wheat flour or wheat and 10% grape seed
        flour or wheat and 40% barley flour, enriched with β-glucan, crackers. Participants consumed
        the same meals, allocating in cross-over order, with 1 washout week after each trial period.
        Differences on the metabolism of postprandial serum total, High Density Lipoprotein (HDL-),
        Low Density Lipoprotein (LDL-) cholesterol, glucose, triglycerides and uric acid levels, as
        well as of plasma total antioxidant capacity according to Ferric Reducing Antioxidant Power
        method, were determined between groups in fasting, thirty minutes, one and a half hour, and
        three hours after meal intake.
  allocation: Randomized
  intervention model: Crossover Assignment
  intervention model description: On enrolment, all subjects were randomly assigned to the C: F1:F2 group (Control: Functional 1: Functional 2), to the F1: C: F2 group (Functional 1: Control: Functional 2) or to the F2: F1: C group (Functional 2: Functional 1: Control). Subjects in the C: F1:F2 group received the Control meal on the first visit, the Functional meal 1 on the second visit and the Functional meal 2 on the third visit; those in the F1:C:F2 group received the Functional meal 1 on the first visit, the Control meal on the second visit and the Functional meal 2 on the third visit while those in the F2:F1:C group received the Functional meal 2 on the first visit, the meal Functional meal 1 on the second visit and the Control meal on the third visit.
  primary purpose: Other
  masking: Single (Participant)
  masking description: Only investigators knew the group in which each participant were enrolled.
  measure: Glucose
  time frame: 3 hours
  description: Glucose concentration changes from baseline at 3hours
  measure: Total Antioxidant Capacity
  time frame: 3 hours
  description: Total Antioxidant Capacity concentration changes from baseline at 3 hours
  measure: Total cholesterol
  time frame: 3 hours
  description: Total cholesterol concentration changes from baseline at 3hours
  measure: High Density Lipoprotein cholesterol
  time frame: 3 hours
  description: High Density Lipoprotein concentration cholesterol changes from baseline at 3hours
  measure: Low Density Lipoprotein cholesterol
  time frame: 3 hours
  description: Low Density Lipoprotein cholesterol concentration changes from baseline at 3hours
  measure: Triglycerides
  time frame: 3 hours
  description: Triglycerides concentration changes from baseline at 3hours
  measure: Uric Acid
  time frame: 3 hours
  description: Uric Acid concentration changes from baseline at 3hours
  arm group label: Control wheat crackers
  arm group type: No Intervention
  description: Volunteers consumed 80g of white bread, 30g of full fat butter and 55g of wheat flour crackers.
  arm group label: Grape seed flour crackers
  arm group type: Other
  description: Volunteers consumed 80g of white bread, 30g of full fat butter and 55g of wheat flour crackers, enriched with 10% grape seed flour crackers.
  arm group label: Barley flour and β-glucan crackers
  arm group type: Other
  description: Volunteers consumed 80g of white bread, 30g of full fat butter and 55g of 60% wheat flour and 40% barley flour crackers, enriched with β-glucan
  intervention type: Other
  intervention name: Functional crackers enriched with grape seed flour
  description: The crackers was enriched with 10% grape seed flour
  arm group label: Grape seed flour crackers
  other name: Grape seed flour crackers
  intervention type: Other
  intervention name: Functional crackers with 40% barley flour and enriched with β-glucans
  description: The crackers consisted of 60% wheat flour, 40% barley flour and was enriched with β-glucans.
  arm group label: Barley flour and β-glucan crackers
  other name: Barley flour crackers
  criteria: 
  gender: All
  minimum age: 19 Years
  maximum age: 65 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Antonios Koutelidakis, Professor
  role: Study Director
  affiliation: University of the Aegean
  facility: 
  country: Greece
  responsible party type: Sponsor
  sharing ipd: No
  ipd description: There are no plans to share individual participant data for this study.