<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/NCT01716390</url>
  </required_header>
  <id_info>
    <org_study_id>CL2010_029</org_study_id>
    <nct_id>NCT01716390</nct_id>
  </id_info>
  <brief_title>Lipid-lowering Effect of Plant Stanol Drink</brief_title>
  <official_title>The Effect of Plant Stanol Drink on Serum Lipids in Comparison to Placebo in Subjects With Mildly to Moderately Elevated Serum Cholesterol Concentrations</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Raisio Group</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Raisio Group</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To determine the effect of investigational products on serum LDL cholesterol.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2011</start_date>
  <completion_date type="Actual">June 2011</completion_date>
  <primary_completion_date type="Actual">May 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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in serum LDL cholesterol</measure>
    <time_frame>0 vs 4 weeks</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">56</enrollment>
  <condition>Hypercholesterolemia</condition>
  <arm_group>
    <arm_group_label>Drink that contains plant stanols</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Dietary supplement: Plant stanol</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo drink</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Dietary supplement: Placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Drink that contains plant stanols</intervention_name>
    <arm_group_label>Drink that contains plant stanols</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo drink</intervention_name>
    <arm_group_label>Placebo drink</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  healthy mildly to moderate hypercholesterolemic (serum total cholesterol 5.2-8.5&#xD;
             mmol/l) adults&#xD;
&#xD;
          -  signed written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  participation in a clinical study within 30 days prior to screening visit and&#xD;
             throughout the study&#xD;
&#xD;
          -  severe obesity&#xD;
&#xD;
          -  consumption of lipid/cholesterol lowering medication 1 month prior to the screening&#xD;
             visit and throughout the study&#xD;
&#xD;
          -  consumption of plant stanol or plant sterol containing food products such as Benecol&#xD;
             or Becel pro active 1 month prior to visit 2&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Johan Olsson, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Good Food Practice, Uppsala, Sweden</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Good Food Practice</name>
      <address>
        <city>Uppsala</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>October 25, 2012</study_first_submitted>
  <study_first_submitted_qc>October 26, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 29, 2012</study_first_posted>
  <last_update_submitted>October 6, 2020</last_update_submitted>
  <last_update_submitted_qc>October 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 8, 2020</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>
  </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/NCT01716390
org study id: CL2010_029
nct id: NCT01716390
lead sponsor: 
has dmc: No
To determine the effect of investigational products on serum LDL cholesterol.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change in serum LDL cholesterol
time frame: 0 vs 4 weeks
arm group label: Drink that contains plant stanols
arm group type: Active Comparator
description: Dietary supplement: Plant stanol
arm group label: Placebo drink
arm group type: Placebo Comparator
description: Dietary supplement: Placebo
intervention type: Dietary Supplement
intervention name: Drink that contains plant stanols
arm group label: Drink that contains plant stanols
intervention type: Dietary Supplement
intervention name: Placebo drink
arm group label: Placebo drink
criteria: 
gender: All
minimum age: 25 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Johan Olsson, PhD
role: Principal Investigator
affiliation: Good Food Practice, Uppsala, Sweden
facility: 
country: Sweden
responsible party type: Sponsor
mesh term: Hypercholesterolemia