<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/NCT03284918</url>
  </required_header>
  <id_info>
    <org_study_id>MFRA004</org_study_id>
    <nct_id>NCT03284918</nct_id>
  </id_info>
  <brief_title>Lipid Lowering Effect of a Cereal Based Snack Bar With Added Plant Stanol Ester</brief_title>
  <official_title>Effect of a Cereal Based Snack Bar With Added Plant Stanol Ester on Serum Total and Lipoprotein Lipids</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Raisio Group</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Medfiles Ltd., Finland</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Raisio Group</source>
  <brief_summary>
    <textblock>
      The purpose of the study is to investigate the cholesterol lowering efficacy of a cereal&#xD;
      based snack bar with added plant stanol ester when used between meals as part of a habitual&#xD;
      diet by subjects with mild to moderate hypercholesterolemia.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2016</start_date>
  <completion_date type="Actual">September 2016</completion_date>
  <primary_completion_date type="Actual">March 2016</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>Percentage change in serum LDL cholesterol</measure>
    <time_frame>4 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Absolute change in serum LDL cholesterol (mmol/l)</measure>
    <time_frame>4 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Absolute and percentage change in serum total, HDL- and non-HDL cholesterol and serum total triglycerides</measure>
    <time_frame>4 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">71</enrollment>
  <condition>Hypercholesterolemia</condition>
  <condition>Hyperlipidemias</condition>
  <condition>Dyslipidemias</condition>
  <arm_group>
    <arm_group_label>Plant stanol ester</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cereal based snack bar with added plant stanol ester (0.8 g plant stanols/bar). Two bars consumed daily as a snack, between meals, for 4 weeks (1.6 g plant stanols/d).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Cereal based snack bar without plant stanol ester. Two bars consumed daily as a snack, between meals, for 4 weeks (0 g plant stanols/d).</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Plant stanol ester</intervention_name>
    <arm_group_label>Plant stanol ester</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Serum total cholesterol 5.2-8.5 mmol/l&#xD;
&#xD;
          -  Serum triglycerides &lt; 3 mmol/l&#xD;
&#xD;
          -  Signed written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Abnormal liver, kidney and thyroid function&#xD;
&#xD;
          -  Use of lipid lowering medication&#xD;
&#xD;
          -  Consumption of other plant sterol or plant stanol containing food products or&#xD;
             supplements, or other foods or supplements for cholesterol lowering 1 month prior to&#xD;
             visit 2&#xD;
&#xD;
          -  History of unstable coronary artery disease (myocardial infarction, coronary artery&#xD;
             bypass graft (CABG), percutaneous transluminal coronary angioplasty (PTCA) within the&#xD;
             previous 6 months&#xD;
&#xD;
          -  Diagnosed type 1 or type 2 diabetes requiring medical treatment&#xD;
&#xD;
          -  History of recent temporal ischemic attack or malignant diseases (&lt; 5 yrs)&#xD;
&#xD;
          -  Celiac disease, or allergy or intolerance to the ingredients of the test products&#xD;
&#xD;
          -  Medically prescribed diet/medication for slimming or a special diet like very low&#xD;
             calorie diet or obesity drug, or vegan and gluten-free diet&#xD;
&#xD;
          -  Subjects with alcohol abuse (&gt; 4 portion per day)&#xD;
&#xD;
          -  Pregnancy or planned pregnancy or lactating&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 13, 2017</study_first_submitted>
  <study_first_submitted_qc>September 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 15, 2017</study_first_posted>
  <last_update_submitted>September 13, 2017</last_update_submitted>
  <last_update_submitted_qc>September 13, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 15, 2017</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/NCT03284918
org study id: MFRA004
nct id: NCT03284918
lead sponsor: 
collaborator: 
The purpose of the study is to investigate the cholesterol lowering efficacy of a cereal
      based snack bar with added plant stanol ester when used between meals as part of a habitual
      diet by subjects with mild to moderate hypercholesterolemia.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Percentage change in serum LDL cholesterol
time frame: 4 weeks
measure: Absolute change in serum LDL cholesterol (mmol/l)
time frame: 4 weeks
measure: Absolute and percentage change in serum total, HDL- and non-HDL cholesterol and serum total triglycerides
time frame: 4 weeks
arm group label: Plant stanol ester
arm group type: Experimental
description: Cereal based snack bar with added plant stanol ester (0.8 g plant stanols/bar). Two bars consumed daily as a snack, between meals, for 4 weeks (1.6 g plant stanols/d).
arm group label: Placebo
arm group type: Placebo Comparator
description: Cereal based snack bar without plant stanol ester. Two bars consumed daily as a snack, between meals, for 4 weeks (0 g plant stanols/d).
intervention type: Dietary Supplement
intervention name: Plant stanol ester
arm group label: Plant stanol ester
intervention type: Dietary Supplement
intervention name: Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Sponsor
mesh term: Hypercholesterolemia
mesh term: Dyslipidemias
mesh term: Hyperlipidemias