<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/NCT02183922</url>
  </required_header>
  <id_info>
    <org_study_id>181/10</org_study_id>
    <nct_id>NCT02183922</nct_id>
  </id_info>
  <brief_title>Microencapsulated Fish Oil or Conjugated Linoleic Acid in Metabolic Syndrome</brief_title>
  <official_title>Hypocaloric Diet With or Without Microencapsulated Fish Oil or Conjugated Linoleic Acid on Oxidative Stress and Cardiovascular Risk Factors in Women With Metabolic Syndrome Genotyped for Polymorphisms in the Genes PPAR Gamma 2 (Pro12Ala) and Adiponectin (G276T)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidade Federal do Rio de Janeiro</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Rio de Janeiro State Research Supporting Foundation (FAPERJ)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Universidade Federal do Rio de Janeiro</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Our aim was to assess the effects of a hypocaloric diet, including diet fruit jelly with&#xD;
      microencapsulated fish oil or conjugated linoleic acid or placebo, on anthropometry, body&#xD;
      composition, insulin resistance and lipid profile in women with metabolic syndrome and&#xD;
      genotype Pro12Pro in the PPAR gamma 2 gene.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>May 2008</start_date>
  <completion_date type="Actual">January 2011</completion_date>
  <primary_completion_date type="Actual">January 2011</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>Factorial Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Oxidative stress biomarker</measure>
    <time_frame>Change from baseline at 12 weeks</time_frame>
    <description>Plasma malondialdehyde levels</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Insulin resistance</measure>
    <time_frame>Change from baseline at 12 weeks</time_frame>
    <description>Homeostatic Model Assessment-Insulin Resistance index, adiponectin, glucose and insulin levels</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lipid profile</measure>
    <time_frame>Change from baseline at 12 weeks</time_frame>
    <description>Total cholesterol, LDL-cholesterol, VLDL-cholesterol, HDL-cholesterol and triglycerides serum levels and EPA, DHA and total conjugated linoleic acid plasma levels</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anthropometric measures</measure>
    <time_frame>Change from baseline at 12 weeks</time_frame>
    <description>Body weight, body mass index and waist circumference</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body composition measures</measure>
    <time_frame>Change from baseline at 12 weeks</time_frame>
    <description>Fat-free mass and fat mass</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood pressure</measure>
    <time_frame>Change from baseline at 12 weeks</time_frame>
    <description>Systolic blood pressure and diastolic blood pressure</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">37</enrollment>
  <condition>Insulin Resistance</condition>
  <condition>Oxidative Stress</condition>
  <condition>Lipid Profile</condition>
  <condition>Blood Pressure</condition>
  <condition>Anthropometric Measure</condition>
  <arm_group>
    <arm_group_label>light fruit jam</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>The placebo group received light fruit jam (15 g/day) during 12 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>microencapsulated fish oil</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The microencapsulated fish oil group received light fruit jam with microencapsulated fish oil (3 g/day) during 12 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>microencapsulated conjugated linoleic acid</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The microencapsulated conjugated linoleic acid group received light fruit jam with microencapsulated conjugated linoleic acid (3 g/day) during 12 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>microencapsulated conjugated linoleic acid</intervention_name>
    <description>The microencapsulated conjugated linoleic acid received light fruit jam with microencapsulated conjugated linoleic acid (3 g/day) during 12 weeks.</description>
    <arm_group_label>microencapsulated conjugated linoleic acid</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>microencapsulated fish oil</intervention_name>
    <description>The microencapsulated fish oil group received light fruit jam with microencapsulated fish oil (3 g/day) during 12 weeks.</description>
    <arm_group_label>microencapsulated fish oil</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>light fruit jam</intervention_name>
    <description>The placebo group received light fruit jam (15 g/day) during 12 weeks.</description>
    <arm_group_label>light fruit jam</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  adults women (30-45 years old);&#xD;
&#xD;
          -  diagnosis of metabolic syndrome, as defined by the International Diabetes Federation;&#xD;
&#xD;
          -  Pro12Pro genotype in gene PPARγ2.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Participants were excluded if they:&#xD;
&#xD;
          -  Were allergic to strawberries or fish&#xD;
&#xD;
          -  Were pregnant or lactating&#xD;
&#xD;
          -  Took fatty acid supplements&#xD;
&#xD;
          -  Had undergone bariatric surgery or were being treated nutritionally or&#xD;
             pharmacologically for reducing BM, or had taken anti-obesity drugs during the previous&#xD;
             three months&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sofia Uehara, Nutritionist</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universidade Federal do Rio de Janeiro</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Universidade Federal do Rio de Janeiro</name>
      <address>
        <city>Rio de Janeiro</city>
        <zip>21941-902</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>June 27, 2014</study_first_submitted>
  <study_first_submitted_qc>July 2, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 8, 2014</study_first_posted>
  <last_update_submitted>July 2, 2014</last_update_submitted>
  <last_update_submitted_qc>July 2, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 8, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidade Federal do Rio de Janeiro</investigator_affiliation>
    <investigator_full_name>Sofia Kimi Uehara</investigator_full_name>
    <investigator_title>Doctor</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>Insulin Resistance</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/NCT02183922
org study id: 181/10
nct id: NCT02183922
lead sponsor: 
collaborator: 
has dmc: No
Our aim was to assess the effects of a hypocaloric diet, including diet fruit jelly with
      microencapsulated fish oil or conjugated linoleic acid or placebo, on anthropometry, body
      composition, insulin resistance and lipid profile in women with metabolic syndrome and
      genotype Pro12Pro in the PPAR gamma 2 gene.
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Oxidative stress biomarker
time frame: Change from baseline at 12 weeks
description: Plasma malondialdehyde levels
measure: Insulin resistance
time frame: Change from baseline at 12 weeks
description: Homeostatic Model Assessment-Insulin Resistance index, adiponectin, glucose and insulin levels
measure: Lipid profile
time frame: Change from baseline at 12 weeks
description: Total cholesterol, LDL-cholesterol, VLDL-cholesterol, HDL-cholesterol and triglycerides serum levels and EPA, DHA and total conjugated linoleic acid plasma levels
measure: Anthropometric measures
time frame: Change from baseline at 12 weeks
description: Body weight, body mass index and waist circumference
measure: Body composition measures
time frame: Change from baseline at 12 weeks
description: Fat-free mass and fat mass
measure: Blood pressure
time frame: Change from baseline at 12 weeks
description: Systolic blood pressure and diastolic blood pressure
arm group label: light fruit jam
arm group type: Placebo Comparator
description: The placebo group received light fruit jam (15 g/day) during 12 weeks.
arm group label: microencapsulated fish oil
arm group type: Experimental
description: The microencapsulated fish oil group received light fruit jam with microencapsulated fish oil (3 g/day) during 12 weeks.
arm group label: microencapsulated conjugated linoleic acid
arm group type: Experimental
description: The microencapsulated conjugated linoleic acid group received light fruit jam with microencapsulated conjugated linoleic acid (3 g/day) during 12 weeks.
intervention type: Dietary Supplement
intervention name: microencapsulated conjugated linoleic acid
description: The microencapsulated conjugated linoleic acid received light fruit jam with microencapsulated conjugated linoleic acid (3 g/day) during 12 weeks.
arm group label: microencapsulated conjugated linoleic acid
intervention type: Dietary Supplement
intervention name: microencapsulated fish oil
description: The microencapsulated fish oil group received light fruit jam with microencapsulated fish oil (3 g/day) during 12 weeks.
arm group label: microencapsulated fish oil
intervention type: Dietary Supplement
intervention name: light fruit jam
description: The placebo group received light fruit jam (15 g/day) during 12 weeks.
arm group label: light fruit jam
criteria: 
gender: Female
minimum age: 30 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Sofia Uehara, Nutritionist
role: Principal Investigator
affiliation: Universidade Federal do Rio de Janeiro
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Universidade Federal do Rio de Janeiro
investigator full name: Sofia Kimi Uehara
investigator title: Doctor
mesh term: Metabolic Syndrome
mesh term: Insulin Resistance