<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/NCT02221297</url>
  </required_header>
  <id_info>
    <org_study_id>CL2014_035</org_study_id>
    <nct_id>NCT02221297</nct_id>
  </id_info>
  <brief_title>Lipid-lowering Effect of a Plant Stanol Ester Supplement Product</brief_title>
  <official_title>Lowering Serum LDL-cholesterol With a Plant Stanol Ester Supplement Product</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Raisio Group</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Clinical Research Institute HUCH Ltd</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Raisio Group</source>
  <brief_summary>
    <textblock>
      Purpose of the study is to determine the effect of the investigational products as consumed&#xD;
      with a meal on serum lipids, primarily on LDL cholesterol.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>May 2014</start_date>
  <completion_date type="Actual">November 2014</completion_date>
  <primary_completion_date type="Actual">November 2014</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Proportional change in serum LDL cholesterol</measure>
    <time_frame>3 to 4 weeks</time_frame>
    <description>Proportional change [end of intervention - start of intervention] in serum LDL-cholesterol between intervention and control groups in subjects fulfilling the inclusion criteria at the beginning of the study.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportional change in total cholesterol</measure>
    <time_frame>3 to 4 weeks</time_frame>
    <description>Proportional change [end of intervention - start of intervention] in serum total cholesterol between intervention and control groups in subjects fulfilling the inclusion criteria at the beginning of the study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportional change in non-HDL-cholesterol</measure>
    <time_frame>3 to 4 weeks</time_frame>
    <description>Proportional change [end of intervention - start of intervention] in serum non-HDL-cholesterol between intervention and control groups in subjects fulfilling the inclusion criteria at the beginning of the study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportional change in serum triglycerides</measure>
    <time_frame>3 to 4 weeks</time_frame>
    <description>Proportional change [end of intervention - start of intervention] in serum triglycerides between intervention and control groups in subjects fulfilling the inclusion criteria at the beginning of the study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportional change in lipids in all study participants</measure>
    <time_frame>3 to 4 weeks</time_frame>
    <description>Proportional change [end of intervention - start of intervention] in serum lipids in all study participants (ITT analysis)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportional change in lipids in subjects without metabolic derangements</measure>
    <time_frame>3 to 4 weeks</time_frame>
    <description>Proportional change [end of intervention - start of intervention] in serum lipids in study participants without metabolic derangements (excluding those with type two diabetes and/or metabolic syndrome)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">103</enrollment>
  <condition>Hypercholesterolemia</condition>
  <condition>Hyperlipidemias</condition>
  <condition>Dyslipidemias</condition>
  <arm_group>
    <arm_group_label>Supplement product with plant stanol ester</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo supplement product</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Supplement product with plant stanol ester</intervention_name>
    <description>2 grams plant stanols consumed with a meal daily for 3 to 4 weeks</description>
    <arm_group_label>Placebo supplement product</arm_group_label>
    <arm_group_label>Supplement product with plant stanol ester</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  male and female over 18 years old&#xD;
&#xD;
          -  serum LDL cholesterol &gt; 3.0 mmol/L&#xD;
&#xD;
          -  BMI &lt; 35&#xD;
&#xD;
          -  subjects must voluntarily sign the informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  subjects using lipid lowering medication (ezetimibe, bile acid sequestrant, statin&#xD;
             therapy)&#xD;
&#xD;
          -  subjects with any hepatic or renal disorder according to medical history&#xD;
&#xD;
          -  subjects who have history of myocardial infarction or unstable angina pectoris within&#xD;
             six months prior to screening&#xD;
&#xD;
          -  subjects who have history of coronary artery bypass graft or percutaneous transluminal&#xD;
             coronary angioplasty within six months prior to screening&#xD;
&#xD;
          -  subjects who have history of temporal ischemic attack or stroke within six months&#xD;
             prior to screening&#xD;
&#xD;
          -  subjects who have a history of cancer or other malignant disease within the past five&#xD;
             years&#xD;
&#xD;
          -  subjects who are consuming more than 15 portions of alcohol / week&#xD;
&#xD;
          -  subjects who are pregnant or lactating&#xD;
&#xD;
          -  subjects using cholesterol-lowering foods or dietary supplements within 14 days before&#xD;
             start of the intervention&#xD;
&#xD;
          -  subjects with intolerance to any ingredient of the test product&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>October 2015</verification_date>
  <study_first_submitted>August 19, 2014</study_first_submitted>
  <study_first_submitted_qc>August 19, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 20, 2014</study_first_posted>
  <last_update_submitted>October 28, 2015</last_update_submitted>
  <last_update_submitted_qc>October 28, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 29, 2015</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>Hypercholesterolemia</mesh_term>
    <mesh_term>Dyslipidemias</mesh_term>
    <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/NCT02221297
org study id: CL2014_035
nct id: NCT02221297
lead sponsor: 
collaborator: 
Purpose of the study is to determine the effect of the investigational products as consumed
      with a meal on serum lipids, primarily on LDL cholesterol.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Proportional change in serum LDL cholesterol
time frame: 3 to 4 weeks
description: Proportional change [end of intervention - start of intervention] in serum LDL-cholesterol between intervention and control groups in subjects fulfilling the inclusion criteria at the beginning of the study.
measure: Proportional change in total cholesterol
time frame: 3 to 4 weeks
description: Proportional change [end of intervention - start of intervention] in serum total cholesterol between intervention and control groups in subjects fulfilling the inclusion criteria at the beginning of the study.
measure: Proportional change in non-HDL-cholesterol
time frame: 3 to 4 weeks
description: Proportional change [end of intervention - start of intervention] in serum non-HDL-cholesterol between intervention and control groups in subjects fulfilling the inclusion criteria at the beginning of the study.
measure: Proportional change in serum triglycerides
time frame: 3 to 4 weeks
description: Proportional change [end of intervention - start of intervention] in serum triglycerides between intervention and control groups in subjects fulfilling the inclusion criteria at the beginning of the study.
measure: Proportional change in lipids in all study participants
time frame: 3 to 4 weeks
description: Proportional change [end of intervention - start of intervention] in serum lipids in all study participants (ITT analysis)
measure: Proportional change in lipids in subjects without metabolic derangements
time frame: 3 to 4 weeks
description: Proportional change [end of intervention - start of intervention] in serum lipids in study participants without metabolic derangements (excluding those with type two diabetes and/or metabolic syndrome)
arm group label: Supplement product with plant stanol ester
arm group type: Experimental
arm group label: Placebo supplement product
arm group type: Placebo Comparator
intervention type: Dietary Supplement
intervention name: Supplement product with plant stanol ester
description: 2 grams plant stanols consumed with a meal daily for 3 to 4 weeks
arm group label: Placebo supplement product
arm group label: Supplement product with plant stanol ester
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Sponsor
mesh term: Hypercholesterolemia
mesh term: Dyslipidemias
mesh term: Hyperlipidemias