<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/NCT02205567</url>
  </required_header>
  <id_info>
    <org_study_id>BMT14</org_study_id>
    <nct_id>NCT02205567</nct_id>
  </id_info>
  <brief_title>Bergamot and Cardio-Metabolic Risk Factors</brief_title>
  <official_title>The Effect of Bergamot on Plasma Lipids, Lipoproteins and Carotid Intima-media Thickness</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Palermo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Palermo</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Bergamot-derived products have shown significant effects on plasma lipids. We aim in the&#xD;
      present study to evaluate the effect of bergamot on several cardio-metabolic risk markers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The research hypothesis is to assess whether bergamot reduces plasma lipids (total&#xD;
      cholesterol, triglycerides, low-density lipoprotein (LDL)-cholesterol and high-density&#xD;
      lipoprotein (HDL)-cholesterol), atherogenic lipoproteins, carotid intima-media thickness&#xD;
      (IMT) and liver steatosis in patients with dyslipidemia.&#xD;
&#xD;
      The primary objective is to assess whether bergamot reduces plasma lipids and atherogenic&#xD;
      lipoproteins in patients with dyslipidemia.&#xD;
&#xD;
      Primary endpoint: Reduction in plasma lipids and atherogenic lipoproteins. The secondary&#xD;
      objective is to assess whether bergamot reduces carotid intima-media thickness (IMT) and&#xD;
      liver steatosis in patients with dyslipidemia.&#xD;
&#xD;
      Secondary endpoint: Reduction in IMT and and liver steatosis.&#xD;
&#xD;
      Clinical diagnostic tools will include the measurement of:&#xD;
&#xD;
        1. cIMT, that will be assessed by B-mode real-time ultrasound using a single sonographer&#xD;
           (Medison SonoAce Pico, with a probe of 7.5-10.0 MHz) in a standardized manner with fixed&#xD;
           angles of insonation;&#xD;
&#xD;
        2. liver steatosis, that will be assessed by by abdominal ultrasound.&#xD;
&#xD;
      Biochemical analyses will include the analysis of:&#xD;
&#xD;
        1. Routine testing of plasma lipids;&#xD;
&#xD;
        2. Atherogenic lipoproteins, e.g. the analysis of 11 distinct lipoproteins including&#xD;
           very-low-density lipoprotein (VLDL), 3 intermediate density lipoprotein (IDL) subclasses&#xD;
           and 7 low density lipoprotein (LDL) subclasses.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2014</start_date>
  <completion_date type="Actual">August 2015</completion_date>
  <primary_completion_date type="Actual">June 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline in plasma lipids</measure>
    <time_frame>baseline and 6 months</time_frame>
    <description>We will measure at baseline and after 6 months the following plasma lipids concentrations: total cholesterol, triglycerides, LDL-cholesterol and HDL-cholesterol.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in atherogenic lipoproteins, carotid intima-media thickness (IMT) and liver steatosis</measure>
    <time_frame>baseline and 6 months</time_frame>
    <description>We will measure at baseline and after 6 months carotid IMT by color doppler ultrasound, atherogenic lipoproteins by electrophoresis and liver steatosis by abdominal ultrasound.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">160</enrollment>
  <condition>Dyslipidemia</condition>
  <arm_group>
    <arm_group_label>Group 2</arm_group_label>
    <description>1000 mg/day of Bergamot-derived product</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 1</arm_group_label>
    <description>500 mg/day of Bergamot-derived product</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Bergamot-derived product</intervention_name>
    <description>Group 1: 500mg/day Group 2: 1000mg/day</description>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_label>Group 2</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Serum and plasma samples&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        adult subjects with dyslipidemia&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  elevated LDL-cholesterolemia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  severe hepatic or renal diseases&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>35 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Giuseppe Montalto, MD</last_name>
    <role>Study Director</role>
    <affiliation>University of Palermo, Italy</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital of Palermo</name>
      <address>
        <city>Palermo</city>
        <state>PA</state>
        <zip>90127</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>August 2015</verification_date>
  <study_first_submitted>July 29, 2014</study_first_submitted>
  <study_first_submitted_qc>July 30, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 31, 2014</study_first_posted>
  <last_update_submitted>August 5, 2015</last_update_submitted>
  <last_update_submitted_qc>August 5, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 6, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Palermo</investigator_affiliation>
    <investigator_full_name>Manfredi Rizzo</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dyslipidemias</mesh_term>
  </condition_browse>
  <!-- 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/NCT02205567
org study id: BMT14
nct id: NCT02205567
lead sponsor: 
has dmc: No
Bergamot-derived products have shown significant effects on plasma lipids. We aim in the
      present study to evaluate the effect of bergamot on several cardio-metabolic risk markers.
The research hypothesis is to assess whether bergamot reduces plasma lipids (total
      cholesterol, triglycerides, low-density lipoprotein (LDL)-cholesterol and high-density
      lipoprotein (HDL)-cholesterol), atherogenic lipoproteins, carotid intima-media thickness
      (IMT) and liver steatosis in patients with dyslipidemia.

      The primary objective is to assess whether bergamot reduces plasma lipids and atherogenic
      lipoproteins in patients with dyslipidemia.

      Primary endpoint: Reduction in plasma lipids and atherogenic lipoproteins. The secondary
      objective is to assess whether bergamot reduces carotid intima-media thickness (IMT) and
      liver steatosis in patients with dyslipidemia.

      Secondary endpoint: Reduction in IMT and and liver steatosis.

      Clinical diagnostic tools will include the measurement of:

        1. cIMT, that will be assessed by B-mode real-time ultrasound using a single sonographer
           (Medison SonoAce Pico, with a probe of 7.5-10.0 MHz) in a standardized manner with fixed
           angles of insonation;

        2. liver steatosis, that will be assessed by by abdominal ultrasound.

      Biochemical analyses will include the analysis of:

        1. Routine testing of plasma lipids;

        2. Atherogenic lipoproteins, e.g. the analysis of 11 distinct lipoproteins including
           very-low-density lipoprotein (VLDL), 3 intermediate density lipoprotein (IDL) subclasses
           and 7 low density lipoprotein (LDL) subclasses.
observational model: Case-Only
time perspective: Prospective
measure: Change from baseline in plasma lipids
time frame: baseline and 6 months
description: We will measure at baseline and after 6 months the following plasma lipids concentrations: total cholesterol, triglycerides, LDL-cholesterol and HDL-cholesterol.
measure: Change from baseline in atherogenic lipoproteins, carotid intima-media thickness (IMT) and liver steatosis
time frame: baseline and 6 months
description: We will measure at baseline and after 6 months carotid IMT by color doppler ultrasound, atherogenic lipoproteins by electrophoresis and liver steatosis by abdominal ultrasound.
arm group label: Group 2
description: 1000 mg/day of Bergamot-derived product
arm group label: Group 1
description: 500 mg/day of Bergamot-derived product
intervention type: Dietary Supplement
intervention name: Bergamot-derived product
description: Group 1: 500mg/day Group 2: 1000mg/day
arm group label: Group 1
arm group label: Group 2
Serum and plasma samples
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 35 Years
maximum age: 75 Years
healthy volunteers: No
last name: Giuseppe Montalto, MD
role: Study Director
affiliation: University of Palermo, Italy
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: University of Palermo
investigator full name: Manfredi Rizzo
investigator title: Assistant Professor
mesh term: Dyslipidemias