<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/NCT02969720</url>
  </required_header>
  <id_info>
    <org_study_id>FESIME-016</org_study_id>
    <nct_id>NCT02969720</nct_id>
  </id_info>
  <brief_title>Therapeutic Efficacy of Phytosterols on Metabolic Syndrome</brief_title>
  <acronym>FESIME</acronym>
  <official_title>Double Blind, Randomized, Phase III, Parallel, Placebo-controled Study to Evaluate Therapeutic Efficacy of 2 Grams Phytosterols Daily Supplemention on Patients With Metabolic Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidad de los Andes, Chile</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidad de los Andes, Chile</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>
      The objective is to evaluate therapeutic efficacy of 2 grams nano-phytosterols daily&#xD;
      supplemention on diagnosis criteria of metabolic syndrome.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 8, 2018</start_date>
  <completion_date type="Actual">November 27, 2018</completion_date>
  <primary_completion_date type="Actual">November 27, 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>Double (Participant, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Difference of proportion between study groups in the proportion of metabolic syndrome from baseline and the last visit (180 days).</measure>
    <time_frame>180 days</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">220</enrollment>
  <condition>Metabolic Syndrome x</condition>
  <arm_group>
    <arm_group_label>Phytosterol</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Daily consumption of 2 grams (8 ml) nano-phytosterols per 180 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Daily consumption of 8 ml of a solution with Titanium Dioxide per 180 days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Phytosterols</intervention_name>
    <description>Oral daily consumption of 2 grams of phytosterols (8 ml) per 180 days.</description>
    <arm_group_label>Phytosterol</arm_group_label>
    <other_name>Cardiosmile</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Titanium Dioxide</intervention_name>
    <description>Oral daily consumption of Titanium Dioxide (8 ml) per 180 days.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Informed consent written&#xD;
&#xD;
          -  Available subjects to follow-up visits&#xD;
&#xD;
          -  Subjects with diagnoses of metabolic syndrome 5 years ago or with current diagnoses&#xD;
             criteria&#xD;
&#xD;
          -  Subjects with health visits ongoing&#xD;
&#xD;
          -  Subjects with arterial hypertension under control.&#xD;
&#xD;
          -  Subjects with mellitus diabetes under control.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects with alcoholism history.&#xD;
&#xD;
          -  Subjects with history of sitosterolemia.&#xD;
&#xD;
          -  Subjects with familiar hypercholesterolemia&#xD;
&#xD;
          -  Subjects who are consuming phytosterols&#xD;
&#xD;
          -  Pregnancy women&#xD;
&#xD;
          -  Breastfeeding period women&#xD;
&#xD;
          -  Subjects with personal history of: acute miocardical infarction, stroke, hypertensive&#xD;
             emergency, acute or chronic diabetes descompensation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Universidad de Los Andes</name>
      <address>
        <city>Santiago</city>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Chile</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>November 17, 2016</study_first_submitted>
  <study_first_submitted_qc>November 17, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2016</study_first_posted>
  <last_update_submitted>March 14, 2020</last_update_submitted>
  <last_update_submitted_qc>March 14, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidad de los Andes, Chile</investigator_affiliation>
    <investigator_full_name>Yasna Palmeiro-Silva</investigator_full_name>
    <investigator_title>Asistant Professor</investigator_title>
  </responsible_party>
  <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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Titanium dioxide</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>PI will share IPD after doing all possible publications.</ipd_description>
  </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/NCT02969720
org study id: FESIME-016
nct id: NCT02969720
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The objective is to evaluate therapeutic efficacy of 2 grams nano-phytosterols daily
      supplemention on diagnosis criteria of metabolic syndrome.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Care Provider)
measure: Difference of proportion between study groups in the proportion of metabolic syndrome from baseline and the last visit (180 days).
time frame: 180 days
arm group label: Phytosterol
arm group type: Experimental
description: Daily consumption of 2 grams (8 ml) nano-phytosterols per 180 days.
arm group label: Placebo
arm group type: Placebo Comparator
description: Daily consumption of 8 ml of a solution with Titanium Dioxide per 180 days.
intervention type: Dietary Supplement
intervention name: Phytosterols
description: Oral daily consumption of 2 grams of phytosterols (8 ml) per 180 days.
arm group label: Phytosterol
other name: Cardiosmile
intervention type: Dietary Supplement
intervention name: Titanium Dioxide
description: Oral daily consumption of Titanium Dioxide (8 ml) per 180 days.
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
country: Chile
responsible party type: Principal Investigator
investigator affiliation: Universidad de los Andes, Chile
investigator full name: Yasna Palmeiro-Silva
investigator title: Asistant Professor
mesh term: Metabolic Syndrome
mesh term: Syndrome
mesh term: Titanium dioxide
sharing ipd: Undecided
ipd description: PI will share IPD after doing all possible publications.