<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/NCT01671254</url>
  </required_header>
  <id_info>
    <org_study_id>POT2-FMR-CT</org_study_id>
    <nct_id>NCT01671254</nct_id>
  </id_info>
  <brief_title>Effect of Citrus Bioflavonoids/Vitamin E in Conjunction With Fish Oil Supplementation</brief_title>
  <official_title>A Double-blind, Placebo-controlled Trial of a Dietary Supplement Containing Citrus Bioflavonoids and Vitamin E at 2 Doses in Conjunction With Fish Oil Supplementation in Hyperlipidemic Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>MetaProteomics LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>MetaProteomics LLC</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this 8-week intervention trial is to investigate the effect of a dietary&#xD;
      supplement (containing citrus bioflavonoids and vitamin E) plus fish oil supplementation in&#xD;
      healthy hyperlipidemic subjects&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">December 2012</completion_date>
  <primary_completion_date type="Actual">December 2012</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>Supportive Care</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>LDL cholesterol</measure>
    <time_frame>Baseline, 8 weeks</time_frame>
    <description>Change in LDL cholesterol level at the end of 8 weeks</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Triglyceride</measure>
    <time_frame>Baseline, 8 weeks</time_frame>
    <description>Change in triglyceride level at the end of 8 weeks.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>oxLDL</measure>
    <time_frame>Baseline, 8 weeks</time_frame>
    <description>Change in oxidized LDL level at the end of 8 weeks.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total cholesterol</measure>
    <time_frame>Baseline, 8 weeks</time_frame>
    <description>Change in total cholesterol level at the end of 8 weeks.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HDL cholesterol</measure>
    <time_frame>Baseline, 8 weeks</time_frame>
    <description>Change in HDL cholesterol level at the end of 8 weeks.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">18</enrollment>
  <condition>Hyperlipidemia</condition>
  <arm_group>
    <arm_group_label>FishOil + placebo</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects in this arm receive fish oil (EPA/DHA Extra Strength) and placebo capsule</description>
  </arm_group>
  <arm_group>
    <arm_group_label>FishOil + CBE75</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects in this arm receive fish oil (EPA/DHA Extra Strength) and citrus bioflavonoids+vitamin E (CBE)(75 mg/capsule/day)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>FishOil + CBE150</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects in this arm receive fish oil (EPA/DHA Extra Strength) and CBE (150 mg/capsule/day)</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>FishOil</intervention_name>
    <arm_group_label>FishOil + CBE150</arm_group_label>
    <arm_group_label>FishOil + CBE75</arm_group_label>
    <arm_group_label>FishOil + placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>CBE75</intervention_name>
    <arm_group_label>FishOil + CBE75</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>CBE150</intervention_name>
    <arm_group_label>FishOil + CBE150</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>placebo</intervention_name>
    <arm_group_label>FishOil + placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  men and women ≥ 18 and ≤ 72 years old&#xD;
&#xD;
          -  generally healthy&#xD;
&#xD;
          -  BMI &gt; 18 and &lt; 38&#xD;
&#xD;
          -  LDL cholesterol ≥ 130 mg/dl and &lt; 270 mg/dl&#xD;
&#xD;
          -  triglycerides ≥ 150 mg/dl and &lt; 400 mg/dl&#xD;
&#xD;
          -  ability to understand and the willingness to sign a written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  use of nutritional supplements and medical foods for dyslipidemia within 30 days prior&#xD;
             to the study&#xD;
&#xD;
          -  use of omega-3 fatty acid dietary supplements within 30 days prior to the study&#xD;
&#xD;
          -  use of prescription HMG-CoA reductase inhibitors, bile acid sequestrants, fibrates,&#xD;
             cholesterol absorption blocking agents, or niacin&#xD;
&#xD;
          -  use of prescription medications and/or nonprescription medications for acute and&#xD;
             semi-acute medical conditions&#xD;
&#xD;
          -  history of cardiovascular disease, type i diabetes, autoimmune disease, liver or&#xD;
             kidney disease, malignancy, and serious mental illness.&#xD;
&#xD;
          -  known infection with HIB, TB, hepatitis B or hepatitis C&#xD;
&#xD;
          -  history of allergy or intolerance to study products&#xD;
&#xD;
          -  smoking, use of nicotine-containing products, or use of drugs of abuse 30 days prior&#xD;
             to the study&#xD;
&#xD;
          -  history of regular intake of &gt; 14 alcoholic drinks per week for females and &gt; 21&#xD;
             drinks per week for males&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>72 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Joseph J Lamb, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>MetaProteomics / Metagenics / FMRC</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Functional Medicine Research Center</name>
      <address>
        <city>Gig Harbor</city>
        <state>Washington</state>
        <zip>98332</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>August 20, 2012</study_first_submitted>
  <study_first_submitted_qc>August 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 23, 2012</study_first_posted>
  <last_update_submitted>May 17, 2018</last_update_submitted>
  <last_update_submitted_qc>May 17, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 18, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hyperlipidemias</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/NCT01671254
org study id: POT2-FMR-CT
nct id: NCT01671254
lead sponsor: 
has dmc: No
The purpose of this 8-week intervention trial is to investigate the effect of a dietary
      supplement (containing citrus bioflavonoids and vitamin E) plus fish oil supplementation in
      healthy hyperlipidemic subjects
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Double (Participant, Investigator)
measure: LDL cholesterol
time frame: Baseline, 8 weeks
description: Change in LDL cholesterol level at the end of 8 weeks
measure: Triglyceride
time frame: Baseline, 8 weeks
description: Change in triglyceride level at the end of 8 weeks.
measure: oxLDL
time frame: Baseline, 8 weeks
description: Change in oxidized LDL level at the end of 8 weeks.
measure: Total cholesterol
time frame: Baseline, 8 weeks
description: Change in total cholesterol level at the end of 8 weeks.
measure: HDL cholesterol
time frame: Baseline, 8 weeks
description: Change in HDL cholesterol level at the end of 8 weeks.
arm group label: FishOil + placebo
arm group type: Active Comparator
description: Subjects in this arm receive fish oil (EPA/DHA Extra Strength) and placebo capsule
arm group label: FishOil + CBE75
arm group type: Experimental
description: Subjects in this arm receive fish oil (EPA/DHA Extra Strength) and citrus bioflavonoids+vitamin E (CBE)(75 mg/capsule/day)
arm group label: FishOil + CBE150
arm group type: Experimental
description: Subjects in this arm receive fish oil (EPA/DHA Extra Strength) and CBE (150 mg/capsule/day)
intervention type: Dietary Supplement
intervention name: FishOil
arm group label: FishOil + CBE150
arm group label: FishOil + CBE75
arm group label: FishOil + placebo
intervention type: Dietary Supplement
intervention name: CBE75
arm group label: FishOil + CBE75
intervention type: Dietary Supplement
intervention name: CBE150
arm group label: FishOil + CBE150
intervention type: Dietary Supplement
intervention name: placebo
arm group label: FishOil + placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 72 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Joseph J Lamb, MD
role: Principal Investigator
affiliation: MetaProteomics / Metagenics / FMRC
facility: 
country: United States
responsible party type: Sponsor
mesh term: Hyperlipidemias