<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/NCT03813914</url>
  </required_header>
  <id_info>
    <org_study_id>Sineos-3</org_study_id>
    <nct_id>NCT03813914</nct_id>
  </id_info>
  <brief_title>A New Supplement for the &quot;Metabolic Syndrome&quot;</brief_title>
  <official_title>Corosolic Acid and Cinnamon for the Treatment of the &quot;Metabolic Syndrome&quot; in Menopausal Transition Women</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Messina</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Messina</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>
      This study evaluates the effect of a combination of glycirrhizic acid, Cinnamomun Zeylanicum&#xD;
      and corosolic acid for the treatment of metabolic syndrome. Participants receive the&#xD;
      supplement or a placebo.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The supplement is composed by of a combination of glycirrhizic acid, Cinnamomun Zeylanicum&#xD;
      and corosolic acid. They act in different way reducing insulin resistance, which is the main&#xD;
      cause of metabolic syndrome. It was a randomized, controlled study involving 60 women with&#xD;
      the metabolic syndrome following the criteria proposed by ATP III in 2015. Main outcomes were&#xD;
      the improvement of the parameters that characterizes the metabolic syndrome, such as glucose&#xD;
      and insulin levels, triglycerides, HDL-cholesterol and blood pressure.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 15, 2017</start_date>
  <completion_date type="Actual">June 30, 2018</completion_date>
  <primary_completion_date type="Actual">January 15, 2018</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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in glycemia</measure>
    <time_frame>3 months</time_frame>
    <description>Reduction of glycemia (mg/dl)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in HDL-cholesterol</measure>
    <time_frame>3 months</time_frame>
    <description>Increase of HDL-C (mg/dl)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>changes in HOMA-IR</measure>
    <time_frame>3 months</time_frame>
    <description>measured as the ratio between glycaemia (mg/dl) and insulin (UI)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>changes in total-cholesterol</measure>
    <time_frame>3 months</time_frame>
    <description>reduction of cholesterol (mg/dl)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>changes in triglycerides</measure>
    <time_frame>3 months</time_frame>
    <description>reduction in triglycerides (mg/dl)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Metabolic Syndrome</condition>
  <arm_group>
    <arm_group_label>Sineos</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Glycyrrhizic acid 38 mg + Cinnamomum Zeylanicum 150 mg + corosolic acid 480 mcg 2 pills/day for 3 months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo comparator</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>placebo 2 pills/day for 3 months</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Sineos</intervention_name>
    <description>glycyrrhizic acid 38 mg + Cinnamomum Zeylanicum 150 mg + corosolic acid 480 mcg 2 pills per day</description>
    <arm_group_label>Placebo comparator</arm_group_label>
    <arm_group_label>Sineos</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria: Postmenopausal women affected by Metabolic Syndrome, diagnosed by ATP&#xD;
        2015 criteria.&#xD;
&#xD;
        -&#xD;
&#xD;
        Exclusion Criteria: treatment with steroids or with hypoglycemic or anti-cholesterol drugs&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>August 7, 2018</study_first_submitted>
  <study_first_submitted_qc>January 21, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 23, 2019</study_first_posted>
  <last_update_submitted>January 21, 2019</last_update_submitted>
  <last_update_submitted_qc>January 21, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 23, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Messina</investigator_affiliation>
    <investigator_full_name>Rosario D'anna</investigator_full_name>
    <investigator_title>Principal Investigator, Clinical professor</investigator_title>
  </responsible_party>
  <keyword>insulin resistance, blood pressure,</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Metabolic Syndrome</mesh_term>
    <mesh_term>Syndrome</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/NCT03813914
org study id: Sineos-3
nct id: NCT03813914
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study evaluates the effect of a combination of glycirrhizic acid, Cinnamomun Zeylanicum
      and corosolic acid for the treatment of metabolic syndrome. Participants receive the
      supplement or a placebo.
The supplement is composed by of a combination of glycirrhizic acid, Cinnamomun Zeylanicum
      and corosolic acid. They act in different way reducing insulin resistance, which is the main
      cause of metabolic syndrome. It was a randomized, controlled study involving 60 women with
      the metabolic syndrome following the criteria proposed by ATP III in 2015. Main outcomes were
      the improvement of the parameters that characterizes the metabolic syndrome, such as glucose
      and insulin levels, triglycerides, HDL-cholesterol and blood pressure.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Changes in glycemia
time frame: 3 months
description: Reduction of glycemia (mg/dl)
measure: Changes in HDL-cholesterol
time frame: 3 months
description: Increase of HDL-C (mg/dl)
measure: changes in HOMA-IR
time frame: 3 months
description: measured as the ratio between glycaemia (mg/dl) and insulin (UI)
measure: changes in total-cholesterol
time frame: 3 months
description: reduction of cholesterol (mg/dl)
measure: changes in triglycerides
time frame: 3 months
description: reduction in triglycerides (mg/dl)
arm group label: Sineos
arm group type: Experimental
description: Glycyrrhizic acid 38 mg + Cinnamomum Zeylanicum 150 mg + corosolic acid 480 mcg 2 pills/day for 3 months
arm group label: Placebo comparator
arm group type: Placebo Comparator
description: placebo 2 pills/day for 3 months
intervention type: Dietary Supplement
intervention name: Sineos
description: glycyrrhizic acid 38 mg + Cinnamomum Zeylanicum 150 mg + corosolic acid 480 mcg 2 pills per day
arm group label: Placebo comparator
arm group label: Sineos
criteria: 
gender: Female
gender based: Yes
minimum age: 45 Years
maximum age: 65 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: University of Messina
investigator full name: Rosario D'anna
investigator title: Principal Investigator, Clinical professor
mesh term: Metabolic Syndrome
mesh term: Syndrome
sharing ipd: No