<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/NCT03019263</url>
  </required_header>
  <id_info>
    <org_study_id>20140012470</org_study_id>
    <nct_id>NCT03019263</nct_id>
  </id_info>
  <brief_title>Berberine, Chlorogenic Acid and Tocotrienols in Menopause-associated Dyslipidemia</brief_title>
  <official_title>Nutraceutical Intervention With Berberine, Chlorogenic Acid and Tocotrienols for Menopause-associated Dyslipidemia: a Randomized, Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>IRCCS Policlinico S. Matteo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Pavia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>IRCCS Policlinico S. Matteo</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>
      Menopause is usually associated with an increase in body weight, a change in body composition&#xD;
      and fat distribution and a large number of cardio-metabolic changes, such as hypertension,&#xD;
      reduction of insulin-sensitivity and dyslipidaemia. The first-line strategy for these&#xD;
      complications is the modification of dietary habits and lifestyle in terms of physical&#xD;
      activity. Besides, there is also a growing interest in complementary therapies (i.e.&#xD;
      nutraceuticals) that can be used alone or in combination to achieve more consistent results.&#xD;
      In this context, preliminary evidence supports the potential role of some compounds of&#xD;
      vegetal origin such as berberine, chlorogenic acid and tocotrienols. However, in support of&#xD;
      their use, the evidence from good quality trials is limited.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 31, 2017</start_date>
  <completion_date type="Actual">January 12, 2018</completion_date>
  <primary_completion_date type="Actual">January 12, 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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>LDL cholesterol</measure>
    <time_frame>3 months</time_frame>
    <description>LDL cholesterol</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Insulin resistance</measure>
    <time_frame>3 months</time_frame>
    <description>Homeostatic model assessment (HOMA index)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total cholesterol</measure>
    <time_frame>3 months</time_frame>
    <description>Total cholesterol</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HDL cholesterol</measure>
    <time_frame>3 months</time_frame>
    <description>HDL cholesterol</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood glucose</measure>
    <time_frame>3 months</time_frame>
    <description>Blood glucose</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum Insulin</measure>
    <time_frame>3 months</time_frame>
    <description>Serum Insulin</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body weight</measure>
    <time_frame>3 months</time_frame>
    <description>Body weight</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fat distribution</measure>
    <time_frame>3 months</time_frame>
    <description>Waist circumference</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fat Mass</measure>
    <time_frame>3 months</time_frame>
    <description>Fat Mass</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Menopausal symptoms</measure>
    <time_frame>3 months</time_frame>
    <description>Greene Climacteric Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life</measure>
    <time_frame>3 months</time_frame>
    <description>36-Item Short Form Health Survey (SF-36)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">63</enrollment>
  <condition>Dyslipidemia</condition>
  <arm_group>
    <arm_group_label>Nutraceutical</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Nutritional counseling plus one pill of an active product (Trixy®) containing Berberine, Tocotrienols and Chlorogenic acid</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Nutritional counseling</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Nutraceutical</intervention_name>
    <description>Nutritional counseling plus one pill of an active product (Trixy®) containing Berberine, Tocotrienols and Chlorogenic acid</description>
    <arm_group_label>Nutraceutical</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Control</intervention_name>
    <description>Nutritional counseling</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  LDL cholesterol &gt;100 mg/dL&#xD;
&#xD;
          -  Written informed consent available&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Use of any drug affecting blood lipids&#xD;
&#xD;
          -  Hormone replacement therapy&#xD;
&#xD;
          -  Adherence to a weigh loss diet in the previous 6 months&#xD;
&#xD;
          -  Cancer diagnosis&#xD;
&#xD;
          -  Known thyroid, liver, renal or muscle diseases&#xD;
&#xD;
          -  Any medical or surgical condition which could lead to an inconstant adhesion to the&#xD;
             protocol&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Fondazione IRCCS Policlinico San Matteo</name>
      <address>
        <city>Pavia</city>
        <zip>27100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>January 10, 2017</study_first_submitted>
  <study_first_submitted_qc>January 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 12, 2017</study_first_posted>
  <last_update_submitted>January 12, 2018</last_update_submitted>
  <last_update_submitted_qc>January 12, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 16, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>IRCCS Policlinico S. Matteo</investigator_affiliation>
    <investigator_full_name>Riccardo Caccialanza</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dyslipidemias</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03019263
org study id: 20140012470
nct id: NCT03019263
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Menopause is usually associated with an increase in body weight, a change in body composition
      and fat distribution and a large number of cardio-metabolic changes, such as hypertension,
      reduction of insulin-sensitivity and dyslipidaemia. The first-line strategy for these
      complications is the modification of dietary habits and lifestyle in terms of physical
      activity. Besides, there is also a growing interest in complementary therapies (i.e.
      nutraceuticals) that can be used alone or in combination to achieve more consistent results.
      In this context, preliminary evidence supports the potential role of some compounds of
      vegetal origin such as berberine, chlorogenic acid and tocotrienols. However, in support of
      their use, the evidence from good quality trials is limited.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: LDL cholesterol
time frame: 3 months
description: LDL cholesterol
measure: Insulin resistance
time frame: 3 months
description: Homeostatic model assessment (HOMA index)
measure: Total cholesterol
time frame: 3 months
description: Total cholesterol
measure: HDL cholesterol
time frame: 3 months
description: HDL cholesterol
measure: Blood glucose
time frame: 3 months
description: Blood glucose
measure: Serum Insulin
time frame: 3 months
description: Serum Insulin
measure: Body weight
time frame: 3 months
description: Body weight
measure: Fat distribution
time frame: 3 months
description: Waist circumference
measure: Fat Mass
time frame: 3 months
description: Fat Mass
measure: Menopausal symptoms
time frame: 3 months
description: Greene Climacteric Scale
measure: Quality of life
time frame: 3 months
description: 36-Item Short Form Health Survey (SF-36)
arm group label: Nutraceutical
arm group type: Experimental
description: Nutritional counseling plus one pill of an active product (Trixy®) containing Berberine, Tocotrienols and Chlorogenic acid
arm group label: Control
arm group type: Active Comparator
description: Nutritional counseling
intervention type: Dietary Supplement
intervention name: Nutraceutical
description: Nutritional counseling plus one pill of an active product (Trixy®) containing Berberine, Tocotrienols and Chlorogenic acid
arm group label: Nutraceutical
intervention type: Other
intervention name: Control
description: Nutritional counseling
arm group label: Control
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: IRCCS Policlinico S. Matteo
investigator full name: Riccardo Caccialanza
investigator title: Principal Investigator
mesh term: Dyslipidemias
sharing ipd: Undecided