<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/NCT03298529</url>
  </required_header>
  <id_info>
    <org_study_id>IG2017C</org_study_id>
    <nct_id>NCT03298529</nct_id>
  </id_info>
  <brief_title>Glycemic Index of Traditional Egg Pasta</brief_title>
  <official_title>Study on Glycemic and Insulin Index Values of Five Types of Pasta With Different Flour Content, and Egg Components</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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The glycemic index (GI) compares the plasma glucose response to a specific amount of&#xD;
      carbohydrates with the response induced by the same amount of carbohydrates from a standard&#xD;
      carbohydrate source, pure glucose in our case. The GI is defined as the incremental area&#xD;
      under the curve (iAUC) for blood glucose after consumption of a test food divided by the iAUC&#xD;
      of a reference food containing the same amount of carbohydrates. GI is based on the&#xD;
      physiologic functions of food carbohydrates rather than on their chemical structure, allowing&#xD;
      to a more accurate classification. Several studies found that the regular consumption of low&#xD;
      glycemic meals reduces the risk of developing diabetes, insulin-resistance, cardiovascular&#xD;
      and neoplastic diseases.&#xD;
&#xD;
      GI was originally developed for insulin-resistant subjects. The maintenance of stable blood&#xD;
      glucose levels is a challenge for people with diabetes and pre-diabetes and is also&#xD;
      beneficial for the general population, as reported by several studies.&#xD;
&#xD;
      Low-GI diets have been shown to:&#xD;
&#xD;
        -  stabilize blood sugar levels&#xD;
&#xD;
        -  improve body weight&#xD;
&#xD;
        -  better control appetite&#xD;
&#xD;
        -  improve memory&#xD;
&#xD;
        -  reduce the risk of cardiovascular diseases&#xD;
&#xD;
        -  reduce the risk of some forms of cancer According to Walter Willet, nutrition researcher&#xD;
           at the Harvard School of Public Health, an excess of sugars and refined starches&#xD;
           stimulates insulin hypersecretion, hunger pangs and frequent snacking, slowing down&#xD;
           lipid metabolism and making people physically less active.&#xD;
&#xD;
      This project aims to evaluate the glycemic index of five different types of pasta with the&#xD;
      same format, named &quot;Fettuccine&quot;, but with different composition (the pasta format is related&#xD;
      to GI variations). The different types of pasta vary for flour and egg composition. However,&#xD;
      having the same format, the GI will change only in response to the percentage content of the&#xD;
      ingredients used to produce pasta. In particular, the aim is to measure egg's effect,&#xD;
      distinct in yolk and white, on the glycemic and insulin response of healthy subjects.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The five types of pasta to be tested are produced by the so called &quot;La Campofilone&quot; Company&#xD;
      (Ficiarà, Campofilone, Marche), a national excellence in the production of traditional egg.&#xD;
      Every pasta is designed and realized with the scientific support of two consultants: Prof.&#xD;
      Paolo De Cristofaro, endocrinologist, diabetologist and professor at the School of&#xD;
      Specialization in Food Science and Nutrition at the University of Chieti, and Prof. Giampiero&#xD;
      Sacchetti, biotechnologist at the Marche Polytechnic University. Specifically, the products&#xD;
      to be tested are:&#xD;
&#xD;
        1. Traditional Fettuccine, original recipe (8 eggs/kg flour) currently available on the&#xD;
           market;&#xD;
&#xD;
        2. Pasta with only 8 egg whites/kg flour;&#xD;
&#xD;
        3. Pasta with 4 eggs/kg flour;&#xD;
&#xD;
        4. Hyperproteic pasta (with added gluten and albumin);&#xD;
&#xD;
        5. Pasta with only 4 egg whites/kg flour.&#xD;
&#xD;
      Each phase of the project will be implemented in accordance with the Jenkins and Wolever&#xD;
      protocol (World Health Organization-Food and Agriculture Organization of the United&#xD;
      Nations,1998). 12 healthy subjects, aged 18-65 years, will be recruited. After a 10 to&#xD;
      12-hour overnight fasting period, standard food (a glucose solution) and food test (the&#xD;
      different types of fettuccine La Campofilone) will be administered to volunteers, organized&#xD;
      into groups of two or three people.&#xD;
&#xD;
      Both test food administrations and standard food administrations will take place on a&#xD;
      different day. The standard food consists of 50 g of glucose dissolved in oligomineral water,&#xD;
      the test food consists of a portion of pasta containing 50 g of available carbohydrates.&#xD;
      Blood samples for determination of glycemia and insulinemia will be taken at time 0 and then&#xD;
      at 15, 30, 45, 60, 90 and 120 minutes from the beginning of the test or standard food intake.&#xD;
      Three glucose response curves will be performed on each subject (this allows to obtain an&#xD;
      average value of the subject's response to glucose over time) while a single test with the&#xD;
      food to be tested will be done. Blood samples will be analyzed at the Service of Medical&#xD;
      Laboratory Analysis of the Hospital &quot;S. De Bellis&quot;. Glucose and insulin values will be used&#xD;
      to calculate the glycemic and insulin index of each product. For each type of tested pasta, a&#xD;
      detailed report will be drawn up, complete with graphs of glycemic response for each subject.&#xD;
      Each report will include the glycemic and insulin index of the product under review.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2017</start_date>
  <completion_date type="Actual">September 25, 2017</completion_date>
  <primary_completion_date type="Actual">September 15, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>glicemic index</measure>
    <time_frame>6 months</time_frame>
    <description>to measure glicemic index of each type of pasta</description>
  </primary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Glycemic Response</condition>
  <condition>Insulinemic Response</condition>
  <condition>Healthy Subjects</condition>
  <arm_group>
    <arm_group_label>Traditional egg pasta</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Traditional egg pasta. 12 healthy subjects, after a 10 to 12-hour overnight fasting period, will assume &quot;fettuccine&quot; pasta made with 8 eggs/kg flour. The serving size is calculated to contain 50 g of carbohydrates according to nutritional analysis of the product.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Pasta with only eight egg whites/kg flour</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Pasta with only eight egg whites/kg flour. 12 healthy subjects, after a 10 to 12-hour overnight fasting period, will assume &quot;fettuccine&quot; pasta with only eight egg whites/kg flour. The serving size is calculated to contain 50 g of carbohydrates according to nutritional analysis of the product.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Pasta with four eggs/kg flour</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Pasta with four eggs/kg flour. 12 healthy subjects, after a 10 to 12-hour overnight fasting period, will assume &quot;fettuccine&quot; pasta with four eggs/kg flour. The serving size is calculated to contain 50 g of carbohydrates according to nutritional analysis of the product.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Hyperproteic pasta (with added gluten and albumin)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Hyperproteic pasta (with added gluten and albumin). 12 healthy subjects, after a 10 to 12-hour overnight fasting period, will assume &quot;fettuccine&quot; pasta with added gluten and albumin. The serving size is calculated to contain 50 g of carbohydrates according to nutritional analysis of the product.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Pasta with only four egg whites/kg flour</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Pasta with only four egg whites/kg flour. 12 healthy subjects, after a 10 to 12-hour overnight fasting period, will assume &quot;fettuccine&quot; pasta with only four egg whites/kg flour. The serving size is calculated to contain 50 g of carbohydrates according to nutritional analysis of the product.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>glucose solution</intervention_name>
    <description>12 healthy subjects, aged 18-65 years, after a 10 to 12-hour overnight fasting period will assume standard food, a glucose solution at 50%</description>
    <arm_group_label>Hyperproteic pasta (with added gluten and albumin)</arm_group_label>
    <arm_group_label>Pasta with four eggs/kg flour</arm_group_label>
    <arm_group_label>Pasta with only eight egg whites/kg flour</arm_group_label>
    <arm_group_label>Pasta with only four egg whites/kg flour</arm_group_label>
    <arm_group_label>Traditional egg pasta</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Traditional egg pasta</intervention_name>
    <description>12 healthy subjects, aged 18-65 years, after a 10 to 12-hour overnight fasting period will assume traditional pasta, with 8 eggs/kg flour. The serving size must contain 50 g of carbohydrates, calculated according to nutritional label</description>
    <arm_group_label>Traditional egg pasta</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Pasta with eight egg whites/kg flour</intervention_name>
    <description>12 healthy subjects, aged 18-65 years, after a 10 to 12-hour overnight fasting period will assume pasta, with eight egg whites/kg flour. The serving size must contain 50 g of carbohydrates, calculated according to nutritional label</description>
    <arm_group_label>Pasta with only eight egg whites/kg flour</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Pasta with four eggs/kg flour</intervention_name>
    <description>12 healthy subjects, aged 18-65 years, after a 10 to 12-hour overnight fasting period will assume pasta, with four egg whites/kg flour. The serving size must contain 50 g of carbohydrates, calculated according to nutritional label</description>
    <arm_group_label>Pasta with four eggs/kg flour</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Hyperproteic pasta (with added gluten and albumin)</intervention_name>
    <description>12 healthy subjects, aged 18-65 years, after a 10 to 12-hour overnight fasting period will assume pasta with added gluten and albumin.The serving size must contain 50 g of carbohydrates, calculated according to nutritional label</description>
    <arm_group_label>Hyperproteic pasta (with added gluten and albumin)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Pasta with only four egg whites/kg flour</intervention_name>
    <description>12 healthy subjects, aged 18-65 years, after a 10 to 12-hour overnight fasting period will assume pasta with four egg whites/kg flour. The serving size must contain 50 g of carbohydrates, calculated according to nutritional label</description>
    <arm_group_label>Pasta with only four egg whites/kg flour</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  healthy volunteers&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnancy and breast feeding&#xD;
&#xD;
          -  athletes&#xD;
&#xD;
          -  current pharmacological therapy or pharmacological therapy interrupted less than 3&#xD;
             months before recruitment.&#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>
  <location>
    <facility>
      <name>Azienda ospedaliera Specializzata in Gastroenterologia Saverio de Bellis</name>
      <address>
        <city>Castellana</city>
        <state>Bari</state>
        <zip>70013</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 12, 2017</study_first_submitted>
  <study_first_submitted_qc>September 29, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 2, 2017</study_first_posted>
  <last_update_submitted>September 29, 2017</last_update_submitted>
  <last_update_submitted_qc>September 29, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 2, 2017</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>Gioacchino Leandro</investigator_full_name>
    <investigator_title>Head of Gastroenterology, Director of the Service of Clinical Nutrition</investigator_title>
  </responsible_party>
  <keyword>Glycemic index</keyword>
  <keyword>Insulinemic index</keyword>
  <keyword>Traditional egg pasta</keyword>
  <!-- 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/NCT03298529
org study id: IG2017C
nct id: NCT03298529
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The glycemic index (GI) compares the plasma glucose response to a specific amount of
      carbohydrates with the response induced by the same amount of carbohydrates from a standard
      carbohydrate source, pure glucose in our case. The GI is defined as the incremental area
      under the curve (iAUC) for blood glucose after consumption of a test food divided by the iAUC
      of a reference food containing the same amount of carbohydrates. GI is based on the
      physiologic functions of food carbohydrates rather than on their chemical structure, allowing
      to a more accurate classification. Several studies found that the regular consumption of low
      glycemic meals reduces the risk of developing diabetes, insulin-resistance, cardiovascular
      and neoplastic diseases.

      GI was originally developed for insulin-resistant subjects. The maintenance of stable blood
      glucose levels is a challenge for people with diabetes and pre-diabetes and is also
      beneficial for the general population, as reported by several studies.

      Low-GI diets have been shown to:

        -  stabilize blood sugar levels

        -  improve body weight

        -  better control appetite

        -  improve memory

        -  reduce the risk of cardiovascular diseases

        -  reduce the risk of some forms of cancer According to Walter Willet, nutrition researcher
           at the Harvard School of Public Health, an excess of sugars and refined starches
           stimulates insulin hypersecretion, hunger pangs and frequent snacking, slowing down
           lipid metabolism and making people physically less active.

      This project aims to evaluate the glycemic index of five different types of pasta with the
      same format, named "Fettuccine", but with different composition (the pasta format is related
      to GI variations). The different types of pasta vary for flour and egg composition. However,
      having the same format, the GI will change only in response to the percentage content of the
      ingredients used to produce pasta. In particular, the aim is to measure egg's effect,
      distinct in yolk and white, on the glycemic and insulin response of healthy subjects.
The five types of pasta to be tested are produced by the so called "La Campofilone" Company
      (Ficiarà, Campofilone, Marche), a national excellence in the production of traditional egg.
      Every pasta is designed and realized with the scientific support of two consultants: Prof.
      Paolo De Cristofaro, endocrinologist, diabetologist and professor at the School of
      Specialization in Food Science and Nutrition at the University of Chieti, and Prof. Giampiero
      Sacchetti, biotechnologist at the Marche Polytechnic University. Specifically, the products
      to be tested are:

        1. Traditional Fettuccine, original recipe (8 eggs/kg flour) currently available on the
           market;

        2. Pasta with only 8 egg whites/kg flour;

        3. Pasta with 4 eggs/kg flour;

        4. Hyperproteic pasta (with added gluten and albumin);

        5. Pasta with only 4 egg whites/kg flour.

      Each phase of the project will be implemented in accordance with the Jenkins and Wolever
      protocol (World Health Organization-Food and Agriculture Organization of the United
      Nations,1998). 12 healthy subjects, aged 18-65 years, will be recruited. After a 10 to
      12-hour overnight fasting period, standard food (a glucose solution) and food test (the
      different types of fettuccine La Campofilone) will be administered to volunteers, organized
      into groups of two or three people.

      Both test food administrations and standard food administrations will take place on a
      different day. The standard food consists of 50 g of glucose dissolved in oligomineral water,
      the test food consists of a portion of pasta containing 50 g of available carbohydrates.
      Blood samples for determination of glycemia and insulinemia will be taken at time 0 and then
      at 15, 30, 45, 60, 90 and 120 minutes from the beginning of the test or standard food intake.
      Three glucose response curves will be performed on each subject (this allows to obtain an
      average value of the subject's response to glucose over time) while a single test with the
      food to be tested will be done. Blood samples will be analyzed at the Service of Medical
      Laboratory Analysis of the Hospital "S. De Bellis". Glucose and insulin values will be used
      to calculate the glycemic and insulin index of each product. For each type of tested pasta, a
      detailed report will be drawn up, complete with graphs of glycemic response for each subject.
      Each report will include the glycemic and insulin index of the product under review.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: glicemic index
time frame: 6 months
description: to measure glicemic index of each type of pasta
arm group label: Traditional egg pasta
arm group type: Experimental
description: Traditional egg pasta. 12 healthy subjects, after a 10 to 12-hour overnight fasting period, will assume "fettuccine" pasta made with 8 eggs/kg flour. The serving size is calculated to contain 50 g of carbohydrates according to nutritional analysis of the product.
arm group label: Pasta with only eight egg whites/kg flour
arm group type: Experimental
description: Pasta with only eight egg whites/kg flour. 12 healthy subjects, after a 10 to 12-hour overnight fasting period, will assume "fettuccine" pasta with only eight egg whites/kg flour. The serving size is calculated to contain 50 g of carbohydrates according to nutritional analysis of the product.
arm group label: Pasta with four eggs/kg flour
arm group type: Experimental
description: Pasta with four eggs/kg flour. 12 healthy subjects, after a 10 to 12-hour overnight fasting period, will assume "fettuccine" pasta with four eggs/kg flour. The serving size is calculated to contain 50 g of carbohydrates according to nutritional analysis of the product.
arm group label: Hyperproteic pasta (with added gluten and albumin)
arm group type: Experimental
description: Hyperproteic pasta (with added gluten and albumin). 12 healthy subjects, after a 10 to 12-hour overnight fasting period, will assume "fettuccine" pasta with added gluten and albumin. The serving size is calculated to contain 50 g of carbohydrates according to nutritional analysis of the product.
arm group label: Pasta with only four egg whites/kg flour
arm group type: Experimental
description: Pasta with only four egg whites/kg flour. 12 healthy subjects, after a 10 to 12-hour overnight fasting period, will assume "fettuccine" pasta with only four egg whites/kg flour. The serving size is calculated to contain 50 g of carbohydrates according to nutritional analysis of the product.
intervention type: Other
intervention name: glucose solution
description: 12 healthy subjects, aged 18-65 years, after a 10 to 12-hour overnight fasting period will assume standard food, a glucose solution at 50%
arm group label: Hyperproteic pasta (with added gluten and albumin)
arm group label: Pasta with four eggs/kg flour
arm group label: Pasta with only eight egg whites/kg flour
arm group label: Pasta with only four egg whites/kg flour
arm group label: Traditional egg pasta
intervention type: Other
intervention name: Traditional egg pasta
description: 12 healthy subjects, aged 18-65 years, after a 10 to 12-hour overnight fasting period will assume traditional pasta, with 8 eggs/kg flour. The serving size must contain 50 g of carbohydrates, calculated according to nutritional label
arm group label: Traditional egg pasta
intervention type: Other
intervention name: Pasta with eight egg whites/kg flour
description: 12 healthy subjects, aged 18-65 years, after a 10 to 12-hour overnight fasting period will assume pasta, with eight egg whites/kg flour. The serving size must contain 50 g of carbohydrates, calculated according to nutritional label
arm group label: Pasta with only eight egg whites/kg flour
intervention type: Other
intervention name: Pasta with four eggs/kg flour
description: 12 healthy subjects, aged 18-65 years, after a 10 to 12-hour overnight fasting period will assume pasta, with four egg whites/kg flour. The serving size must contain 50 g of carbohydrates, calculated according to nutritional label
arm group label: Pasta with four eggs/kg flour
intervention type: Other
intervention name: Hyperproteic pasta (with added gluten and albumin)
description: 12 healthy subjects, aged 18-65 years, after a 10 to 12-hour overnight fasting period will assume pasta with added gluten and albumin.The serving size must contain 50 g of carbohydrates, calculated according to nutritional label
arm group label: Hyperproteic pasta (with added gluten and albumin)
intervention type: Other
intervention name: Pasta with only four egg whites/kg flour
description: 12 healthy subjects, aged 18-65 years, after a 10 to 12-hour overnight fasting period will assume pasta with four egg whites/kg flour. The serving size must contain 50 g of carbohydrates, calculated according to nutritional label
arm group label: Pasta with only four egg whites/kg flour
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
investigator full name: Gioacchino Leandro
investigator title: Head of Gastroenterology, Director of the Service of Clinical Nutrition