<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/NCT04494607</url>
  </required_header>
  <id_info>
    <org_study_id>RC2020_IRCCS</org_study_id>
    <nct_id>NCT04494607</nct_id>
  </id_info>
  <brief_title>Glycemic Index of Various Types of Pasta in Healthy Volunteers</brief_title>
  <official_title>Evaluation of the Glycemic Index of Various Types of Pasta in Healthy Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis</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>
      he project aims to evaluate the glycemic index of different types of pasta with different&#xD;
      formats and with different types of flour. In particular, we want to know the effect of the&#xD;
      format and the different type of flour on the glycemic and insulinemic response.&#xD;
&#xD;
      Specific objective 1: determination of the glycemic index of the product concerned.&#xD;
&#xD;
      Specific objective 2: determination of the insulinemic index of the product concerned.&#xD;
&#xD;
      Specific objective 3: determination of the pasta format and the type of flour with a lower&#xD;
      glycemic and insulinemic index.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study is divided into the following phases:&#xD;
&#xD;
      Phase 1: screening of subjects aimed at identifying possession of the inclusion criteria&#xD;
      necessary for participation in the study;&#xD;
&#xD;
      Phase 2: Enrollment of the subject and for each of the enlisted subjects, execution of the&#xD;
      first and second determination of the glycemic and insulinemic response curve with the&#xD;
      standard glucose solution 30 days apart; 15 days after the second determination of the&#xD;
      glycemic and insulinemic response to the glucose load, the assumption of the food test will&#xD;
      be performed on which to measure the glycemic index (type of pasta) and evaluation of the&#xD;
      glycemic and insulinemic response curve to this food ; finally, after a further 30 days, the&#xD;
      third determination of the glycemic and insulinemic response curve will be performed with the&#xD;
      standard glucose solution;&#xD;
&#xD;
      Phase 3: statistical processing of the results of phase 2 and determination of the glycemic&#xD;
      index and insulinemic index for each type of pasta tested;&#xD;
&#xD;
      Phase 4: description of the results of phase 3 with indication to the supplier company of the&#xD;
      pasta format and the type of flour with lower glycemic and insulinemic index.&#xD;
&#xD;
      More phases detailed:&#xD;
&#xD;
      Phase 1 Voluntarily enrolled subjects undergo a clinical history to exclude the pathologies&#xD;
      present in the exclusion criteria and a routine blood sample to exclude metabolic alterations&#xD;
      affecting the metabolism of sugars, lipids, uric acid, and liver.&#xD;
&#xD;
      Phase 2: The subjects considered suitable to enter the study will be subjected to the&#xD;
      administration of the standard glucose solution for the determination of the first glycemic&#xD;
      and insulinemic curve. The standard solution consists of 50 g of glucose dissolved in 200 cc&#xD;
      of trace mineral water, which the subject will be invited to drink in about 10 minutes.&#xD;
      Venous blood samples for the determination of glucose and insulin will be collected at time&#xD;
      0, and then at 15, 30, 45, 60, 90 and 120 minutes from the start of the standard intake of&#xD;
      the glucose solution. In case of a normal response to the first determination of the glycemic&#xD;
      and insulinemic curve, the subject will continue in the study; otherwise it will be excluded&#xD;
      and will be directed to clinical study paths to assess the presence of any pathologies not&#xD;
      yet concluded (diabetes, reduced response to insulin, etc.).&#xD;
&#xD;
      Follow all subjects eligible to continue the study and at least 12 participants, 30 days&#xD;
      after the first glucose load curve, will be subjected to the second administration of the&#xD;
      standard glucose solution according to the procedures described above.&#xD;
&#xD;
      After 15 days, the same subjects will be given a portion of pasta (food on which to measure&#xD;
      the glycemic index) containing 50 grams of available carbohydrates. The determination of the&#xD;
      quantity of carbohydrates inside the product (pasta) on which it determines the glycemic&#xD;
      index must be done with a direct method and supplied by the food company together with the&#xD;
      pasta samples. The subject will be invited to consume the pasta in 15 minutes while sipping&#xD;
      200 cc of mineral water at the same time. Blood samples for the determination of blood sugar&#xD;
      and insulin will be collected at time 0, and then at 15, 30, 45, 60, 90 and 120 minutes from&#xD;
      the start of the pasta intake.&#xD;
&#xD;
      After another 30 days, the third glucose response curve and all insulin will be performed on&#xD;
      each subject, with the other modalities of the first two loading curves (this provides an&#xD;
      average value of the subject's response to glucose over time).&#xD;
&#xD;
      Phase 3: Statistical processing of the results of phase 2 and determination of the glycemic&#xD;
      index and insulinemic index for each type of pasta tested.&#xD;
&#xD;
      Phase 4: For each type of pasta tested, a detailed report will be drawn up, complete with&#xD;
      graphs relating to the glycemic and insulinemic response for each subject. Each report will&#xD;
      include the glycemic and insulinemic index values of the product concerned.&#xD;
&#xD;
      This will allow to determine which pasta format and which type of flour has the lowest&#xD;
      glycemic and insulinemic index.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 2020</start_date>
  <completion_date type="Anticipated">December 2021</completion_date>
  <primary_completion_date type="Anticipated">September 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Glycemic Index determination</measure>
    <time_frame>1 year</time_frame>
    <description>determination of the glycemic index for the product in study</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Insulinemic Index determination</measure>
    <time_frame>1 year</time_frame>
    <description>determination of the glycemic index for the product in study</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Best cereal made product identification</measure>
    <time_frame>1,5 years</time_frame>
    <description>determination of the pasta format and the type of flour with a lower glycemic and insulinemic index</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">12</enrollment>
  <condition>Glycemic Index</condition>
  <arm_group>
    <arm_group_label>Test arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Determination of Glycemic and Insulinemic curves under different alimentary intake</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>lowest Glycemic Index for a selected type fo cereal product</intervention_name>
    <description>determination of lowest Glycemic Index for a selected type fo cereal product</description>
    <arm_group_label>Test arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy subjects&#xD;
&#xD;
          -  No carbohydrate intolerance or diabetes&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Intolerance ascertained to the products in study (celiac syndrome)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Maria Gabriella Dr Caruso, MD</last_name>
    <phone>+390804994651</phone>
    <email>gabriella.caruso@irccsdebellis.it</email>
  </overall_contact>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>June 15, 2020</study_first_submitted>
  <study_first_submitted_qc>July 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 31, 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 31, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis</investigator_affiliation>
    <investigator_full_name>Maria Gabriella Caruso</investigator_full_name>
    <investigator_title>M.D</investigator_title>
  </responsible_party>
  <!-- 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/NCT04494607
org study id: RC2020_IRCCS
nct id: NCT04494607
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
he project aims to evaluate the glycemic index of different types of pasta with different
      formats and with different types of flour. In particular, we want to know the effect of the
      format and the different type of flour on the glycemic and insulinemic response.

      Specific objective 1: determination of the glycemic index of the product concerned.

      Specific objective 2: determination of the insulinemic index of the product concerned.

      Specific objective 3: determination of the pasta format and the type of flour with a lower
      glycemic and insulinemic index.
The study is divided into the following phases:

      Phase 1: screening of subjects aimed at identifying possession of the inclusion criteria
      necessary for participation in the study;

      Phase 2: Enrollment of the subject and for each of the enlisted subjects, execution of the
      first and second determination of the glycemic and insulinemic response curve with the
      standard glucose solution 30 days apart; 15 days after the second determination of the
      glycemic and insulinemic response to the glucose load, the assumption of the food test will
      be performed on which to measure the glycemic index (type of pasta) and evaluation of the
      glycemic and insulinemic response curve to this food ; finally, after a further 30 days, the
      third determination of the glycemic and insulinemic response curve will be performed with the
      standard glucose solution;

      Phase 3: statistical processing of the results of phase 2 and determination of the glycemic
      index and insulinemic index for each type of pasta tested;

      Phase 4: description of the results of phase 3 with indication to the supplier company of the
      pasta format and the type of flour with lower glycemic and insulinemic index.

      More phases detailed:

      Phase 1 Voluntarily enrolled subjects undergo a clinical history to exclude the pathologies
      present in the exclusion criteria and a routine blood sample to exclude metabolic alterations
      affecting the metabolism of sugars, lipids, uric acid, and liver.

      Phase 2: The subjects considered suitable to enter the study will be subjected to the
      administration of the standard glucose solution for the determination of the first glycemic
      and insulinemic curve. The standard solution consists of 50 g of glucose dissolved in 200 cc
      of trace mineral water, which the subject will be invited to drink in about 10 minutes.
      Venous blood samples for the determination of glucose and insulin will be collected at time
      0, and then at 15, 30, 45, 60, 90 and 120 minutes from the start of the standard intake of
      the glucose solution. In case of a normal response to the first determination of the glycemic
      and insulinemic curve, the subject will continue in the study; otherwise it will be excluded
      and will be directed to clinical study paths to assess the presence of any pathologies not
      yet concluded (diabetes, reduced response to insulin, etc.).

      Follow all subjects eligible to continue the study and at least 12 participants, 30 days
      after the first glucose load curve, will be subjected to the second administration of the
      standard glucose solution according to the procedures described above.

      After 15 days, the same subjects will be given a portion of pasta (food on which to measure
      the glycemic index) containing 50 grams of available carbohydrates. The determination of the
      quantity of carbohydrates inside the product (pasta) on which it determines the glycemic
      index must be done with a direct method and supplied by the food company together with the
      pasta samples. The subject will be invited to consume the pasta in 15 minutes while sipping
      200 cc of mineral water at the same time. Blood samples for the determination of blood sugar
      and insulin will be collected at time 0, and then at 15, 30, 45, 60, 90 and 120 minutes from
      the start of the pasta intake.

      After another 30 days, the third glucose response curve and all insulin will be performed on
      each subject, with the other modalities of the first two loading curves (this provides an
      average value of the subject's response to glucose over time).

      Phase 3: Statistical processing of the results of phase 2 and determination of the glycemic
      index and insulinemic index for each type of pasta tested.

      Phase 4: For each type of pasta tested, a detailed report will be drawn up, complete with
      graphs relating to the glycemic and insulinemic response for each subject. Each report will
      include the glycemic and insulinemic index values of the product concerned.

      This will allow to determine which pasta format and which type of flour has the lowest
      glycemic and insulinemic index.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Glycemic Index determination
time frame: 1 year
description: determination of the glycemic index for the product in study
measure: Insulinemic Index determination
time frame: 1 year
description: determination of the glycemic index for the product in study
measure: Best cereal made product identification
time frame: 1,5 years
description: determination of the pasta format and the type of flour with a lower glycemic and insulinemic index
arm group label: Test arm
arm group type: Experimental
description: Determination of Glycemic and Insulinemic curves under different alimentary intake
intervention type: Dietary Supplement
intervention name: lowest Glycemic Index for a selected type fo cereal product
description: determination of lowest Glycemic Index for a selected type fo cereal product
arm group label: Test arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Maria Gabriella Dr Caruso, MD
phone: +390804994651
email: gabriella.caruso@irccsdebellis.it
responsible party type: Principal Investigator
investigator affiliation: Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
investigator full name: Maria Gabriella Caruso
investigator title: M.D