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/NCT06032260</url>
    </required_header>
    <id_info>
      <org_study_id>PAN_2023</org_study_id>
      <nct_id>NCT06032260</nct_id>
    </id_info>
    <brief_title>The Effects of a Fiber-enriched Bakery Product on Glucose, Insulin Values and Appetite</brief_title>
    <official_title>The Effects of a Fiber-enriched Bakery Product on Glucose, Insulin Values and Appetite. A Pilot Randomized Cross-over Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Turin, Italy</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Turin, Italy</source>
    <oversight_info>
      <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 the present pilot randomized controlled trial is to compare the effects of the&#xD;
        following: 1)-panettone enriched with arabinoxylans (p-rich), 2)-panettone not enriched&#xD;
        (p-standard) on blood glucose and insulin values, and appetite scores in 10 healthy&#xD;
        volunteers.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a crossover, randomized double-blind trial. A product enriched with arabinoxylan&#xD;
        extracted from threshing (panettone, p-rich, a sweet baked product with a high glycemic&#xD;
        index) was developed to assess the impact on metabolic responses and satiety when compared to&#xD;
        the standard product (p-standard) .&#xD;
  &#xD;
        Ten Caucasian non-smoker healthy adult volunteers were enrolled starting from January 2023.&#xD;
  &#xD;
        Participants were randomized to receive either the p-rich or p-standard. The order of&#xD;
        administration of each product was randomized using a computer-generated sequence. The day of&#xD;
        each test, fasting individuals underwent a blood sample collection, and weight and height&#xD;
        measurements. Then, participants consumed 100 grams of the product within 20 minutes, while&#xD;
        sitting. Blood samples were collected at 15, 30, 45, 60, 90, 120 minutes after the&#xD;
        consumption of each food.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">January 20, 2023</start_date>
    <completion_date type="Actual">July 30, 2023</completion_date>
    <primary_completion_date type="Actual">June 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 double-blind trial</intervention_model_description>
      <primary_purpose>Prevention</primary_purpose>
      <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
      <masking_description>Neither the participant nor the investigators were aware of the composition of the administered food. The two types of foods were identical for packages, color, flavor, smell, and appearance. Furthermore, the researchers who analyzed data and the laboratory personnel who performed the biochemical analyses were blinded to the group assigned.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Changes in circulating concentrations of glucose</measure>
      <time_frame>15, 30, 45, 60, 90, 120 minutes after the consumption of each food</time_frame>
      <description>To evaluate changes in glucose responses after the consumption of p-rich when compared to p-standard</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Changes in circulating concentrations of insulin</measure>
      <time_frame>15, 30, 45, 60, 90, 120 minutes after the consumption of each food</time_frame>
      <description>To evaluate changes in insulin responses after the consumption of p-rich when compared to p-standard</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in subjective appetite score (VAS)</measure>
      <time_frame>60, 120, 180, and 240 minutes after the consumption of each food</time_frame>
      <description>To evaluate changes in appetite responses after the consumption of p-rich when compared to p-standard. Subjective sensations of appetite were assessed by a visual analogue scale (VAS) ranging from 0 to 10.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">10</enrollment>
    <condition>Healthy</condition>
    <arm_group>
      <arm_group_label>Enriched panettone</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>100 grams of panettone enriched with fiber. The added fiber is JAX Plus® (Heallo srl, Milano, Italy), a soluble fiber with Arabinoxylans from wheat and barley</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Panettone standard</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>100 grams of panettone without fiber enrichment</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Enriched panettone</intervention_name>
      <description>Volunteers consumed 100 grams of panettone enriched with fiber (JAX Plus® (Heallo srl, Milano, Italy), a soluble fiber with Arabinoxylans from wheat and barley</description>
      <arm_group_label>Enriched panettone</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Panettone standard</intervention_name>
      <description>Volunteers consumed 100 grams of panettone standard</description>
      <arm_group_label>Panettone standard</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  non-smokers healthy adults;&#xD;
  &#xD;
            -  age 20-65 years;&#xD;
  &#xD;
            -  ability to provide informed written consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  obesity;&#xD;
  &#xD;
            -  chronic diseases or pharmacological therapies;&#xD;
  &#xD;
            -  dietary restrictions;&#xD;
  &#xD;
            -  allergy or intolerance to the tested food&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>University of Turin</name>
        <address>
          <city>Turin</city>
          <state>AT</state>
          <zip>10126</zip>
          <country>Italy</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Italy</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 31, 2023</study_first_submitted>
    <study_first_submitted_qc>September 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 11, 2023</study_first_posted>
    <last_update_submitted>September 11, 2023</last_update_submitted>
    <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Turin, Italy</investigator_affiliation>
      <investigator_full_name>Simona Bo</investigator_full_name>
      <investigator_title>Associate Professor</investigator_title>
    </responsible_party>
    <keyword>Arabinoxylan</keyword>
    <keyword>fiber-enriched product</keyword>
    <keyword>glycemia</keyword>
    <keyword>insulin</keyword>
    <keyword>appetite</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/NCT06032260
  org study id: PAN_2023
  nct id: NCT06032260
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The aim of the present pilot randomized controlled trial is to compare the effects of the
        following: 1)-panettone enriched with arabinoxylans (p-rich), 2)-panettone not enriched
        (p-standard) on blood glucose and insulin values, and appetite scores in 10 healthy
        volunteers.
  This is a crossover, randomized double-blind trial. A product enriched with arabinoxylan
        extracted from threshing (panettone, p-rich, a sweet baked product with a high glycemic
        index) was developed to assess the impact on metabolic responses and satiety when compared to
        the standard product (p-standard) .
  
        Ten Caucasian non-smoker healthy adult volunteers were enrolled starting from January 2023.
  
        Participants were randomized to receive either the p-rich or p-standard. The order of
        administration of each product was randomized using a computer-generated sequence. The day of
        each test, fasting individuals underwent a blood sample collection, and weight and height
        measurements. Then, participants consumed 100 grams of the product within 20 minutes, while
        sitting. Blood samples were collected at 15, 30, 45, 60, 90, 120 minutes after the
        consumption of each food.
  allocation: Randomized
  intervention model: Crossover Assignment
  intervention model description: crossover randomized double-blind trial
  primary purpose: Prevention
  masking: Triple (Participant, Investigator, Outcomes Assessor)
  masking description: Neither the participant nor the investigators were aware of the composition of the administered food. The two types of foods were identical for packages, color, flavor, smell, and appearance. Furthermore, the researchers who analyzed data and the laboratory personnel who performed the biochemical analyses were blinded to the group assigned.
  measure: Changes in circulating concentrations of glucose
  time frame: 15, 30, 45, 60, 90, 120 minutes after the consumption of each food
  description: To evaluate changes in glucose responses after the consumption of p-rich when compared to p-standard
  measure: Changes in circulating concentrations of insulin
  time frame: 15, 30, 45, 60, 90, 120 minutes after the consumption of each food
  description: To evaluate changes in insulin responses after the consumption of p-rich when compared to p-standard
  measure: Changes in subjective appetite score (VAS)
  time frame: 60, 120, 180, and 240 minutes after the consumption of each food
  description: To evaluate changes in appetite responses after the consumption of p-rich when compared to p-standard. Subjective sensations of appetite were assessed by a visual analogue scale (VAS) ranging from 0 to 10.
  arm group label: Enriched panettone
  arm group type: Experimental
  description: 100 grams of panettone enriched with fiber. The added fiber is JAX Plus® (Heallo srl, Milano, Italy), a soluble fiber with Arabinoxylans from wheat and barley
  arm group label: Panettone standard
  arm group type: Active Comparator
  description: 100 grams of panettone without fiber enrichment
  intervention type: Other
  intervention name: Enriched panettone
  description: Volunteers consumed 100 grams of panettone enriched with fiber (JAX Plus® (Heallo srl, Milano, Italy), a soluble fiber with Arabinoxylans from wheat and barley
  arm group label: Enriched panettone
  intervention type: Other
  intervention name: Panettone standard
  description: Volunteers consumed 100 grams of panettone standard
  arm group label: Panettone standard
  criteria: 
  gender: All
  minimum age: 20 Years
  maximum age: 65 Years
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  country: Italy
  responsible party type: Principal Investigator
  investigator affiliation: University of Turin, Italy
  investigator full name: Simona Bo
  investigator title: Associate Professor
  sharing ipd: No