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/NCT06012227</url>
    </required_header>
    <id_info>
      <org_study_id>UCagliari2</org_study_id>
      <nct_id>NCT06012227</nct_id>
    </id_info>
    <brief_title>Assessment Metabolic Flexibility in Middle-aged Individuals: The Nutritional Impact of Cheese Consumption</brief_title>
    <acronym>Kent'Erbas</acronym>
    <official_title>Assessment Metabolic Flexibility by Indirect Calorimetry and Circulating Metabolic Parameters in Middle-aged Individuals: The Nutritional Impact of Cheese From Extensive and Intensive Farming.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Cagliari</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Cagliari</source>
    <oversight_info>
      <has_dmc>Yes</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 the study will be to evaluate the impact of consumption of meat and dairy products&#xD;
        from extensive or intensive farming on apparently healthy individuals aged between 45 and 65&#xD;
        years, a stage of life associated with reduced metabolic flexibility and changes in lipid&#xD;
        metabolism.&#xD;
  &#xD;
        The study will analyze:&#xD;
  &#xD;
          1. The transcription factor PPAR-α determined by the gene expression of PPAR-α in white&#xD;
             blood cells, variations in circulating fatty acid metabolism, and the endocannabinoid&#xD;
             system determined by circulating analysis of N-acylethanolamine (NAE), and&#xD;
             2-monoacylglycerols (2-MG);&#xD;
  &#xD;
          2. Metabolic flexibility, determined by indirect calorimetry in fasting condition during an&#xD;
             incremental exercise;&#xD;
  &#xD;
          3. Body composition, determined by bioimpedance analysis, waist circumference, and&#xD;
             waist-to-hip ratio.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The study will be a double-blind crossover intervention clinical trial conducted on the&#xD;
        aforementioned individuals, who will consume &quot;kent'erbas&quot; cheese products, from extensive and&#xD;
        intensive farming.&#xD;
  &#xD;
        The study will include 105 individuals aged between 45 and 65 years, apparently in good&#xD;
        health, recruited from the UTIC cardiology unit of A.O.U.CA Cagliari (Italy). All&#xD;
        participants will be provided with a detailed explanation of the study procedures and its&#xD;
        purpose, and their participation will be contingent upon signing an informed consent form.&#xD;
        Throughout the study, subjects will maintain their regular lifestyle and unrestricted food&#xD;
        intake.&#xD;
  &#xD;
        At the outset of the study, relevant information necessary for an appropriate approach to&#xD;
        each participant will be collected, including a comprehensive medical history, measurement of&#xD;
        anthropometric parameters, and blood sampling for a thorough hematological, inflammatory, and&#xD;
        lipid-metabolomic analysis.&#xD;
  &#xD;
        In the pecorino study, subjects will consume 350g/week of &quot;kent'erbas&quot; pecorino from&#xD;
        extensive farming or 350g/week of &quot;industrial&quot; pecorino from intensive farming for 4 weeks in&#xD;
        total. At the end of this period, a blood sample will be taken. Subsequently, there will be a&#xD;
        8 weeks washout period during which participants will follow their usual diet without&#xD;
        consuming either type of pecorino. At the end of the washout period, an additional blood&#xD;
        sample will be taken. Following this, the participants who had consumed &quot;kent'erbas&quot; pecorino&#xD;
        will switch to &quot;industrial&quot; pecorino for 4 weeks, and vice versa. At the end of this second&#xD;
        period, a final blood sample will be collected.&#xD;
  &#xD;
        The quantities of pecorino cheese chosen for intake are representative of the average&#xD;
        consumption in Italy.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">January 20, 2022</start_date>
    <completion_date type="Anticipated">December 20, 2026</completion_date>
    <primary_completion_date type="Actual">July 27, 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>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Participant, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Changes in plasma levels of DHA and acylethanolamides as Metabolic indices of PPAR-α induction increase in plasma levels of DHA</measure>
      <time_frame>After 4 weeks of treatment, 8 weeks of washout and 4 weeks of crossover</time_frame>
      <description>Changes in plasma levels of DHA)and modulation of the endocannabinoid system, through the biosynthesis of AEA, PEA, and OEA. All these parameters will be assessed as pmoles/ml of plasma</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Quotient respiratory changes measurement as metabolic flexibility indices</measure>
      <time_frame>After 4 weeks of treatment, 8 weeks of washout and 4 weeks of crossover</time_frame>
      <description>Metabolic flexibility indices, through fasting differences in the respiratory quotient, measured as Liter/min of Oxygen consumption and carbon dioxide</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">105</enrollment>
    <condition>Metabolism</condition>
    <condition>Nutrition</condition>
    <arm_group>
      <arm_group_label>&quot;kent'erbas&quot; pecorino from extensive farming with crossover Arm 1</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>This study was a 4-week, randomized, controlled, crossover clinical trial. Arm 1: Volunteers will be randomize to be allocated to eat 350g/week of &quot;kent'erbas&quot; pecorino from extensive farming with a crossover with arm 2 after 6 weeks of washout.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>&quot;industrial&quot; pecorino from intensive farming with crossover Arm 2</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>This study was a 4-week, randomized, controlled, crossover clinical trial. Arm 2 : Volunteers will be randomize to be allocated to eat 350g/week of &quot;industrial&quot; pecorino from intensive farming for 4 weeks in total, with a crossover with arm 1 after 6 weeks of washout.</description>
    </arm_group>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>kent'erbas cheese study</intervention_name>
      <description>Nutritional intervention with &quot;kent'erbas&quot; pecorino from extensive farming with crossover and &quot;industrial&quot; pecorino from intensive farming</description>
      <arm_group_label>&quot;industrial&quot; pecorino from intensive farming with crossover Arm 2</arm_group_label>
      <arm_group_label>&quot;kent'erbas&quot; pecorino from extensive farming with crossover Arm 1</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  45-65 years of age&#xD;
  &#xD;
            -  BMI &lt; 27&#xD;
  &#xD;
            -  waist-to-hip ratio female&lt;0.85; male &lt; 0.98&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  metabolic diseases&#xD;
  &#xD;
            -  Physical activity of competitive nature&#xD;
  &#xD;
            -  Vegans and vegetarians&#xD;
  &#xD;
            -  Intolerances and allergies to the foods under study&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <gender_based>Yes</gender_based>
      <minimum_age>45 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Sebastiano Banni</last_name>
      <phone>070-6754128</phone>
      <email>banni@unica.it</email>
    </overall_contact>
    <location>
      <facility>
        <name>University of Cagliari</name>
        <address>
          <city>Monserrato</city>
          <state>Cagliari</state>
          <zip>09042</zip>
          <country>Italy</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Sebastiano Banni</last_name>
        <phone>070-6754128</phone>
        <email>banni@unica.it</email>
      </contact>
    </location>
    <location_countries>
      <country>Italy</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 28, 2023</study_first_submitted>
    <study_first_submitted_qc>August 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 25, 2023</study_first_posted>
    <last_update_submitted>August 26, 2023</last_update_submitted>
    <last_update_submitted_qc>August 26, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 30, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Cagliari</investigator_affiliation>
      <investigator_full_name>Sebastiano Banni</investigator_full_name>
      <investigator_title>full professor</investigator_title>
    </responsible_party>
    <keyword>metabolic flexibility</keyword>
    <keyword>lipid metabolism</keyword>
    <!-- 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/NCT06012227
  org study id: UCagliari2
  nct id: NCT06012227
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The aim of the study will be to evaluate the impact of consumption of meat and dairy products
        from extensive or intensive farming on apparently healthy individuals aged between 45 and 65
        years, a stage of life associated with reduced metabolic flexibility and changes in lipid
        metabolism.
  
        The study will analyze:
  
          1. The transcription factor PPAR-α determined by the gene expression of PPAR-α in white
             blood cells, variations in circulating fatty acid metabolism, and the endocannabinoid
             system determined by circulating analysis of N-acylethanolamine (NAE), and
             2-monoacylglycerols (2-MG);
  
          2. Metabolic flexibility, determined by indirect calorimetry in fasting condition during an
             incremental exercise;
  
          3. Body composition, determined by bioimpedance analysis, waist circumference, and
             waist-to-hip ratio.
  The study will be a double-blind crossover intervention clinical trial conducted on the
        aforementioned individuals, who will consume "kent'erbas" cheese products, from extensive and
        intensive farming.
  
        The study will include 105 individuals aged between 45 and 65 years, apparently in good
        health, recruited from the UTIC cardiology unit of A.O.U.CA Cagliari (Italy). All
        participants will be provided with a detailed explanation of the study procedures and its
        purpose, and their participation will be contingent upon signing an informed consent form.
        Throughout the study, subjects will maintain their regular lifestyle and unrestricted food
        intake.
  
        At the outset of the study, relevant information necessary for an appropriate approach to
        each participant will be collected, including a comprehensive medical history, measurement of
        anthropometric parameters, and blood sampling for a thorough hematological, inflammatory, and
        lipid-metabolomic analysis.
  
        In the pecorino study, subjects will consume 350g/week of "kent'erbas" pecorino from
        extensive farming or 350g/week of "industrial" pecorino from intensive farming for 4 weeks in
        total. At the end of this period, a blood sample will be taken. Subsequently, there will be a
        8 weeks washout period during which participants will follow their usual diet without
        consuming either type of pecorino. At the end of the washout period, an additional blood
        sample will be taken. Following this, the participants who had consumed "kent'erbas" pecorino
        will switch to "industrial" pecorino for 4 weeks, and vice versa. At the end of this second
        period, a final blood sample will be collected.
  
        The quantities of pecorino cheese chosen for intake are representative of the average
        consumption in Italy.
  allocation: Randomized
  intervention model: Crossover Assignment
  primary purpose: Treatment
  masking: Double (Participant, Investigator)
  measure: Changes in plasma levels of DHA and acylethanolamides as Metabolic indices of PPAR-α induction increase in plasma levels of DHA
  time frame: After 4 weeks of treatment, 8 weeks of washout and 4 weeks of crossover
  description: Changes in plasma levels of DHA)and modulation of the endocannabinoid system, through the biosynthesis of AEA, PEA, and OEA. All these parameters will be assessed as pmoles/ml of plasma
  measure: Quotient respiratory changes measurement as metabolic flexibility indices
  time frame: After 4 weeks of treatment, 8 weeks of washout and 4 weeks of crossover
  description: Metabolic flexibility indices, through fasting differences in the respiratory quotient, measured as Liter/min of Oxygen consumption and carbon dioxide
  arm group label: "kent'erbas" pecorino from extensive farming with crossover Arm 1
  arm group type: Experimental
  description: This study was a 4-week, randomized, controlled, crossover clinical trial. Arm 1: Volunteers will be randomize to be allocated to eat 350g/week of "kent'erbas" pecorino from extensive farming with a crossover with arm 2 after 6 weeks of washout.
  arm group label: "industrial" pecorino from intensive farming with crossover Arm 2
  arm group type: Active Comparator
  description: This study was a 4-week, randomized, controlled, crossover clinical trial. Arm 2 : Volunteers will be randomize to be allocated to eat 350g/week of "industrial" pecorino from intensive farming for 4 weeks in total, with a crossover with arm 1 after 6 weeks of washout.
  intervention type: Dietary Supplement
  intervention name: kent'erbas cheese study
  description: Nutritional intervention with "kent'erbas" pecorino from extensive farming with crossover and "industrial" pecorino from intensive farming
  arm group label: "industrial" pecorino from intensive farming with crossover Arm 2
  arm group label: "kent'erbas" pecorino from extensive farming with crossover Arm 1
  criteria: 
  gender: All
  gender based: Yes
  minimum age: 45 Years
  maximum age: 65 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Sebastiano Banni
  phone: 070-6754128
  email: banni@unica.it
  facility: 
  status: Recruiting
  contact: 
  country: Italy
  responsible party type: Principal Investigator
  investigator affiliation: University of Cagliari
  investigator full name: Sebastiano Banni
  investigator title: full professor