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/NCT05988580</url>
    </required_header>
    <id_info>
      <org_study_id>ALISSEC 2.0</org_study_id>
      <nct_id>NCT05988580</nct_id>
    </id_info>
    <brief_title>Postprandial Glycemia After Eating a Pasta Dish Made With Resistant Starch.</brief_title>
    <acronym>ALISSEC2</acronym>
    <official_title>Evaluation of Postprandial Glycemia After Eating a Pasta Dish Made With Resistant Starch.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Clinica Universidad de Navarra, Universidad de Navarra</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Clinica Universidad de Navarra, Universidad de Navarra</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>
        Resistant starch partially resists hydrolyzation by digestive enzymes in humans.&#xD;
        Consequently, it is not absorbed in the small intestine and goes directly to the large&#xD;
        intestine, where it is fermented by the intestinal microbiota, acting as a prebiotic and&#xD;
        stimulating the growth of beneficial bacteria in the colon. In addition, the effect of&#xD;
        resistant starch on postprandial glucose metabolism is studying. Thus, the present research&#xD;
        on healthy subjects has been proposed.&#xD;
  &#xD;
        The main objective is to assess the effect on postprandial glycemia of eating a pasta dish&#xD;
        made with resistant starch versus its original version.&#xD;
  &#xD;
        For this purpose, a randomized, double blind crossover study has been designed.&#xD;
  &#xD;
        Target sample size is 18 subjects.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The arms of the study are two:&#xD;
  &#xD;
          -  Experimental group (pasta dish made with resistant starch).&#xD;
  &#xD;
          -  Control group (original pasta dish).&#xD;
  &#xD;
        Volunteers who wish to participate in the study will be interviewed by phone to verify that&#xD;
        they meet the main inclusion criteria. Volunteers who meet the main inclusion criteria will&#xD;
        be invited to an information and screening visit to resolve any doubts. Volunteers who agree&#xD;
        to participate in the study will sign the informed consent and will be randomly assigned to&#xD;
        one of the two arms of the study.&#xD;
  &#xD;
        The two visits (clinical investigation days) of the study will take place with the volunteers&#xD;
        in a fasting state of 4 hours and separated by at least 1 week washout period. The day before&#xD;
        the visit, volunteers won't be able to drink alcohol, drink and eat excessively, and/or sleep&#xD;
        few hours. Both visits will consist of eating a pasta dish in a maximum of 15 minutes. Blood&#xD;
        samples will be taken before eating and during the 2.5 hours after (30, 60, 90, 120 and 150&#xD;
        minutes), in order to analyze the evolution of blood glucose and insulin levels.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">November 15, 2023</completion_date>
    <primary_completion_date type="Anticipated">October 31, 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>Randomised, double blind crossover intervention</intervention_model_description>
      <primary_purpose>Prevention</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
      <masking_description>The products (experimental and placebo), will be produced by an external producer, who will retain the codes. None of the researchers involved in the study development or analyses will know the association until the end of the study.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Baseline blood glucose</measure>
      <time_frame>0 min in the Clinical investigation day 1 and Clinical investigation day 2 (at least 7 days after the clinical investigation day 1)</time_frame>
      <description>Blood glucose levels before start eating the pasta dish in each clinical investigation day will be analyzed by biochemical autoanalyzer and reported in mg/dL.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Postprandial blood glucose</measure>
      <time_frame>30, 60, 90, 120 and 150 min after start eating the pasta dish in the Clinical investigation day 1 and Clinical investigation day 2</time_frame>
      <description>Blood glucose levels after start eating the pasta dish in each clinical investigation day will be analyzed by biochemical autoanalyzer and reported in mg/dL.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Glycemia Area Under the Curve</measure>
      <time_frame>Baseline, 30, 60, 90, 120 and 150 minutes in the Clinical investigation day 1 and Clinical investigation day 2</time_frame>
      <description>Postprandial glycemia levels after eating pasta dish in each clinical investigation day will be analyzed biochemical autoanalyzer and reported in mg/dL. Glycemia AUC will be calculated by the trapezoidal rule.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Insulinemia Area Under the Curve</measure>
      <time_frame>Baseline, 30, 60, 90, 120 and 150 minutes in Clinical investigation day 1 and Clinical investigation day 2</time_frame>
      <description>Postprandial insulin levels after eating pasta dish in each clinical investigation day will be analyzed by ELISA and reported in mU/L. Insulinemia AUC will be calculated by the trapezoidal rule.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Baseline blood insulin</measure>
      <time_frame>0 min in the Clinical investigation day 1 and Clinical investigation day 2</time_frame>
      <description>Blood insulin levels before start eating the pasta dish in each clinical investigation day will be analyzed by ELISA and reported in mU/L.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Postprandial blood insulin</measure>
      <time_frame>30, 60, 90, 120 and 150 min after start eating in the Clinical investigation day 1 and Clinical investigation day 2.</time_frame>
      <description>Blood insulin levels after start eating the pasta dish in each clinical investigation day will be analyzed by ELISA and reported in mU/L.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Body weight</measure>
      <time_frame>Clinical Investigation Day 1 (before eat the pasta dish) and Clinical Investigation Day 2 (before eat the pasta dish)</time_frame>
      <description>Weight of participants will be measured by bioimpedance and reported in kg</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Height</measure>
      <time_frame>Clinical Investigation Day 1 (before eat the pasta dish) and Clinical Investigation Day 2 (before eat the pasta dish)</time_frame>
      <description>Height of participants will be measured by stadiometer and reported in m.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Body mass index</measure>
      <time_frame>Clinical Investigation Day 1 (before eat the pasta dish) and Clinical Investigation Day 2 (before eat the pasta dish)</time_frame>
      <description>Body mass index will be calculated as follows: weight (kg)/ height (cm)2.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Acceptance of pasta dish</measure>
      <time_frame>Clinical Investigation Day 1 (after eat the pasta dish) and Clinical Investigation Day 2 (after eat the pasta dish)</time_frame>
      <description>Pasta dish acceptance will be analyzed by acceptance questionnaire.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">18</enrollment>
    <condition>Postprandial Glycemia</condition>
    <condition>Resistant Starch</condition>
    <arm_group>
      <arm_group_label>Experimental group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Subjects will consume a pasta dish with 20-22% of resistant starch</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Subjects will consume the original version of pasta dish</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Pasta dish with resistant starch</intervention_name>
      <description>Pasta dish with 20-22% of resistant starch</description>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_label>Experimental group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Original version of pasta dish</intervention_name>
      <description>Original pasta dish, not reinforced with resistant starch</description>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_label>Experimental group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age: 18-65 years.&#xD;
  &#xD;
            -  Body mass index: 18.5-29.9 kg/m2&#xD;
  &#xD;
            -  Volunteers who like and feel good with the ingredients of the dish.&#xD;
  &#xD;
            -  Good physical and psychological state.&#xD;
  &#xD;
            -  Volunteers undergoing pharmacological treatment will be maintained if the dose is&#xD;
               stable for at least 3 months before the start of the study, excluding treatments that&#xD;
               alter gastrointestinal function or glucose metabolism.&#xD;
  &#xD;
            -  Subjects must be able to understand and be willing to sign the informed consent, and&#xD;
               must comply with all the procedures and requirements of the study.&#xD;
  &#xD;
            -  No weight variations considered relevant (+/- 3kg) in the last 3 months.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Subjects with relevant functional or structural abnormalities of the digestive system,&#xD;
               such as malformations, angiodysplasias, active peptic ulcers, chronic inflammatory or&#xD;
               malabsorption diseases, hiatal hernia, reflux, etc.&#xD;
  &#xD;
            -  Subjects who have undergone surgical interventions with permanent sequelae in the&#xD;
               digestive system (for example, gastroduodenostomy).&#xD;
  &#xD;
            -  Subjects with a high alcohol intake, more than 14 units (women) and 20 units (men).&#xD;
  &#xD;
            -  Women who are breastfeeding or pregnant.&#xD;
  &#xD;
            -  Subjects with liver disease.&#xD;
  &#xD;
            -  Subjects with some type of cancer or undergoing treatment for it, or who have not had&#xD;
               a period of at least 5 years since its eradication.&#xD;
  &#xD;
            -  Subjects with allergies to any component of the product under study or any other food&#xD;
               that interferes and makes it difficult to monitor the study.&#xD;
  &#xD;
            -  Subjects who present some type of cognitive and/or psychic impairment.&#xD;
  &#xD;
            -  Subjects in whom poor collaboration is expected or who, in the opinion of the&#xD;
               investigator, have difficulties in following the study procedures.&#xD;
  &#xD;
            -  Subjects who work the night shift.&#xD;
  &#xD;
            -  Subjects who follow some type of supplementation that interferes with the study.&#xD;
  &#xD;
            -  Subjects who are immersed in some treatment for weight loss.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <gender_based>Yes</gender_based>
      <gender_description>Balanced in men and women</gender_description>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Fermín I Milagro Yoldi, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Navarra</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Idoia Ibero-Baraibar, PhD</last_name>
      <role>Study Chair</role>
      <affiliation>University of Navarra</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Carlos J González-Navarro, PhD</last_name>
      <role>Study Chair</role>
      <affiliation>University of Navarra</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Miguel López-Yoldi, PhD</last_name>
      <role>Study Chair</role>
      <affiliation>University of Navarra</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Salomé Pérez Diez</last_name>
      <role>Study Chair</role>
      <affiliation>University of Navarra</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Blanca Martínez de Morentin</last_name>
      <role>Study Chair</role>
      <affiliation>University of Navarra</affiliation>
    </overall_official>
    <overall_official>
      <last_name>José I Riezu-Boj, PhD</last_name>
      <role>Study Chair</role>
      <affiliation>University of Navarra</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Fermín I Milagro Yoldi, PhD</last_name>
      <phone>+34948425600</phone>
      <phone_ext>806553</phone_ext>
      <email>fmilagro@unav.es</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Idoia Ibero-Baraibar, PhD</last_name>
      <phone>+34948425600</phone>
      <phone_ext>806699</phone_ext>
      <email>iibero@unav.es</email>
    </overall_contact_backup>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>August 4, 2023</study_first_submitted>
    <study_first_submitted_qc>August 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 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 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Resistant starch</keyword>
    <keyword>Postprandial glycemia</keyword>
    <keyword>Postprandial insulinemia</keyword>
    <keyword>Pasta</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/NCT05988580
  org study id: ALISSEC 2.0
  nct id: NCT05988580
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Resistant starch partially resists hydrolyzation by digestive enzymes in humans.
        Consequently, it is not absorbed in the small intestine and goes directly to the large
        intestine, where it is fermented by the intestinal microbiota, acting as a prebiotic and
        stimulating the growth of beneficial bacteria in the colon. In addition, the effect of
        resistant starch on postprandial glucose metabolism is studying. Thus, the present research
        on healthy subjects has been proposed.
  
        The main objective is to assess the effect on postprandial glycemia of eating a pasta dish
        made with resistant starch versus its original version.
  
        For this purpose, a randomized, double blind crossover study has been designed.
  
        Target sample size is 18 subjects.
  The arms of the study are two:
  
          -  Experimental group (pasta dish made with resistant starch).
  
          -  Control group (original pasta dish).
  
        Volunteers who wish to participate in the study will be interviewed by phone to verify that
        they meet the main inclusion criteria. Volunteers who meet the main inclusion criteria will
        be invited to an information and screening visit to resolve any doubts. Volunteers who agree
        to participate in the study will sign the informed consent and will be randomly assigned to
        one of the two arms of the study.
  
        The two visits (clinical investigation days) of the study will take place with the volunteers
        in a fasting state of 4 hours and separated by at least 1 week washout period. The day before
        the visit, volunteers won't be able to drink alcohol, drink and eat excessively, and/or sleep
        few hours. Both visits will consist of eating a pasta dish in a maximum of 15 minutes. Blood
        samples will be taken before eating and during the 2.5 hours after (30, 60, 90, 120 and 150
        minutes), in order to analyze the evolution of blood glucose and insulin levels.
  allocation: Randomized
  intervention model: Crossover Assignment
  intervention model description: Randomised, double blind crossover intervention
  primary purpose: Prevention
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  masking description: The products (experimental and placebo), will be produced by an external producer, who will retain the codes. None of the researchers involved in the study development or analyses will know the association until the end of the study.
  measure: Baseline blood glucose
  time frame: 0 min in the Clinical investigation day 1 and Clinical investigation day 2 (at least 7 days after the clinical investigation day 1)
  description: Blood glucose levels before start eating the pasta dish in each clinical investigation day will be analyzed by biochemical autoanalyzer and reported in mg/dL.
  measure: Postprandial blood glucose
  time frame: 30, 60, 90, 120 and 150 min after start eating the pasta dish in the Clinical investigation day 1 and Clinical investigation day 2
  description: Blood glucose levels after start eating the pasta dish in each clinical investigation day will be analyzed by biochemical autoanalyzer and reported in mg/dL.
  measure: Glycemia Area Under the Curve
  time frame: Baseline, 30, 60, 90, 120 and 150 minutes in the Clinical investigation day 1 and Clinical investigation day 2
  description: Postprandial glycemia levels after eating pasta dish in each clinical investigation day will be analyzed biochemical autoanalyzer and reported in mg/dL. Glycemia AUC will be calculated by the trapezoidal rule.
  measure: Insulinemia Area Under the Curve
  time frame: Baseline, 30, 60, 90, 120 and 150 minutes in Clinical investigation day 1 and Clinical investigation day 2
  description: Postprandial insulin levels after eating pasta dish in each clinical investigation day will be analyzed by ELISA and reported in mU/L. Insulinemia AUC will be calculated by the trapezoidal rule.
  measure: Baseline blood insulin
  time frame: 0 min in the Clinical investigation day 1 and Clinical investigation day 2
  description: Blood insulin levels before start eating the pasta dish in each clinical investigation day will be analyzed by ELISA and reported in mU/L.
  measure: Postprandial blood insulin
  time frame: 30, 60, 90, 120 and 150 min after start eating in the Clinical investigation day 1 and Clinical investigation day 2.
  description: Blood insulin levels after start eating the pasta dish in each clinical investigation day will be analyzed by ELISA and reported in mU/L.
  measure: Body weight
  time frame: Clinical Investigation Day 1 (before eat the pasta dish) and Clinical Investigation Day 2 (before eat the pasta dish)
  description: Weight of participants will be measured by bioimpedance and reported in kg
  measure: Height
  time frame: Clinical Investigation Day 1 (before eat the pasta dish) and Clinical Investigation Day 2 (before eat the pasta dish)
  description: Height of participants will be measured by stadiometer and reported in m.
  measure: Body mass index
  time frame: Clinical Investigation Day 1 (before eat the pasta dish) and Clinical Investigation Day 2 (before eat the pasta dish)
  description: Body mass index will be calculated as follows: weight (kg)/ height (cm)2.
  measure: Acceptance of pasta dish
  time frame: Clinical Investigation Day 1 (after eat the pasta dish) and Clinical Investigation Day 2 (after eat the pasta dish)
  description: Pasta dish acceptance will be analyzed by acceptance questionnaire.
  arm group label: Experimental group
  arm group type: Experimental
  description: Subjects will consume a pasta dish with 20-22% of resistant starch
  arm group label: Control group
  arm group type: Placebo Comparator
  description: Subjects will consume the original version of pasta dish
  intervention type: Other
  intervention name: Pasta dish with resistant starch
  description: Pasta dish with 20-22% of resistant starch
  arm group label: Control group
  arm group label: Experimental group
  intervention type: Other
  intervention name: Original version of pasta dish
  description: Original pasta dish, not reinforced with resistant starch
  arm group label: Control group
  arm group label: Experimental group
  criteria: 
  gender: All
  gender based: Yes
  gender description: Balanced in men and women
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Fermín I Milagro Yoldi, PhD
  role: Principal Investigator
  affiliation: University of Navarra
  last name: Idoia Ibero-Baraibar, PhD
  role: Study Chair
  affiliation: University of Navarra
  last name: Carlos J González-Navarro, PhD
  role: Study Chair
  affiliation: University of Navarra
  last name: Miguel López-Yoldi, PhD
  role: Study Chair
  affiliation: University of Navarra
  last name: Salomé Pérez Diez
  role: Study Chair
  affiliation: University of Navarra
  last name: Blanca Martínez de Morentin
  role: Study Chair
  affiliation: University of Navarra
  last name: José I Riezu-Boj, PhD
  role: Study Chair
  affiliation: University of Navarra
  last name: Fermín I Milagro Yoldi, PhD
  phone: +34948425600
  phone ext: 806553
  email: fmilagro@unav.es
  last name: Idoia Ibero-Baraibar, PhD
  phone: +34948425600
  phone ext: 806699
  email: iibero@unav.es
  responsible party type: Sponsor
  sharing ipd: No