<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/NCT04433429</url>
  </required_header>
  <id_info>
    <org_study_id>3497/AO/15</org_study_id>
    <nct_id>NCT04433429</nct_id>
  </id_info>
  <brief_title>Nutraceuticals and Vascular Remodelling</brief_title>
  <acronym>MALTRO</acronym>
  <official_title>Lipid Profile and Vascular Remodelling in Young Dyslipidemic Subjects Treated With Nutraceuticals Derived From Red Yeast Rice.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Marcello Rattazzi</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Padova</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>
      Aim of the study is to assess the effect of a long-term nutraceutical multitarget approach on&#xD;
      lipid profile, inflammatory mediators and vascular remodeling in primary cardiovascular&#xD;
      prevention in a setting of controlled dietary habits. The nutraceutical combination used in&#xD;
      this study consists of a single pill containing 333 mg of RYR, equivalent to 10 mg of&#xD;
      Monacolin K, and 30 mg of Coenzyme Q10 (CoQ10).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>May 2016</start_date>
  <completion_date type="Actual">December 2017</completion_date>
  <primary_completion_date type="Actual">December 2017</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 cholesterol levels at one year</measure>
    <time_frame>Baseline and one year</time_frame>
    <description>Total Cholesterol will be measured in the blood sample from each patient and expressed as mg/dl</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline in carotid intima media thickening at one year</measure>
    <time_frame>Baseline and one year</time_frame>
    <description>Carotid ultrasound examination is performed at baseline and after one year to measure intima-media thickness (IMT). IMT is defined as the distance in mm between the lumen-intima and the media-adventitia interfaces, it is measured at end diastole in the far wall of the right and left sides of the common carotid artery, the bulb and the internal carotid artery. Carotid IMT measurements are expressed as cumulative mean of mean-IMT (m-IMT) recorded in each vascular segment .</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">30</enrollment>
  <condition>Hypercholesterolemia</condition>
  <arm_group>
    <arm_group_label>RYR plus CoQ</arm_group_label>
    <description>333 mg of red yeast rice (RYR, equivalent to 10 mg of Monacolin K) plus 30 mg of Coenzyme Q10 (CoQ10) in a single pill once daily</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Liposcudil Plus</intervention_name>
    <arm_group_label>RYR plus CoQ</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects with mild hypercholeterolemia and low-to moderate cardiovascular risk profile&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Total Cholesterol &gt; 150 mg/dl and &lt; 250 mg/dl;&#xD;
&#xD;
          -  Triglycerides &gt; 150 mg/dl and &lt; 500 mg/dl;&#xD;
&#xD;
          -  Fasting glucose &lt; 126 mg/dl;&#xD;
&#xD;
          -  Stable antihypertensive treatment (at least for 6 months) in presence of hypertension.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Total Cholesterol &gt; 250 mg/dl&#xD;
&#xD;
          -  Triglycerides &gt; 500 mg/dl&#xD;
&#xD;
          -  Previous statin therapy (last 6 months);&#xD;
&#xD;
          -  Treatment with hypoglycemic agents and/or fasting glucose &gt; 126 mg/dl;&#xD;
&#xD;
          -  Chronic gastrointestinal disorders;&#xD;
&#xD;
          -  Chronic kidney disease (eGFR &lt; 60 ml/min/1.73 m2);&#xD;
&#xD;
          -  Concomitant treatment with drugs potentially interfering with glucose and lipid&#xD;
             metabolism; - History of cardiovascular diseases;&#xD;
&#xD;
          -  Proven intolerance to any component of the nutraceutical product;&#xD;
&#xD;
          -  Pregnancy or breastfeeding.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Azienda Ospedaliera di Padova</name>
      <address>
        <city>Padova</city>
        <zip>35125</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 10, 2020</study_first_submitted>
  <study_first_submitted_qc>June 12, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>June 12, 2020</last_update_submitted>
  <last_update_submitted_qc>June 12, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Padova</investigator_affiliation>
    <investigator_full_name>Marcello Rattazzi</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Atherosclerosis</keyword>
  <keyword>Carotid</keyword>
  <keyword>Lipid profile</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypercholesterolemia</mesh_term>
    <mesh_term>Vascular Remodeling</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04433429
org study id: 3497/AO/15
nct id: NCT04433429
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Aim of the study is to assess the effect of a long-term nutraceutical multitarget approach on
      lipid profile, inflammatory mediators and vascular remodeling in primary cardiovascular
      prevention in a setting of controlled dietary habits. The nutraceutical combination used in
      this study consists of a single pill containing 333 mg of RYR, equivalent to 10 mg of
      Monacolin K, and 30 mg of Coenzyme Q10 (CoQ10).
observational model: Case-Only
time perspective: Prospective
measure: Change from baseline in cholesterol levels at one year
time frame: Baseline and one year
description: Total Cholesterol will be measured in the blood sample from each patient and expressed as mg/dl
measure: Change from baseline in carotid intima media thickening at one year
time frame: Baseline and one year
description: Carotid ultrasound examination is performed at baseline and after one year to measure intima-media thickness (IMT). IMT is defined as the distance in mm between the lumen-intima and the media-adventitia interfaces, it is measured at end diastole in the far wall of the right and left sides of the common carotid artery, the bulb and the internal carotid artery. Carotid IMT measurements are expressed as cumulative mean of mean-IMT (m-IMT) recorded in each vascular segment .
arm group label: RYR plus CoQ
description: 333 mg of red yeast rice (RYR, equivalent to 10 mg of Monacolin K) plus 30 mg of Coenzyme Q10 (CoQ10) in a single pill once daily
intervention type: Dietary Supplement
intervention name: Liposcudil Plus
arm group label: RYR plus CoQ
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 30 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Italy
responsible party type: Sponsor-Investigator
investigator affiliation: University of Padova
investigator full name: Marcello Rattazzi
investigator title: Associate Professor
mesh term: Hypercholesterolemia
mesh term: Vascular Remodeling
sharing ipd: No