<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/NCT02990260</url>
  </required_header>
  <id_info>
    <org_study_id>2016-A011094-47</org_study_id>
    <nct_id>NCT02990260</nct_id>
  </id_info>
  <brief_title>Effect of Saccharomyces Cerevisiae in LDL Cholesterol</brief_title>
  <acronym>HONEY</acronym>
  <sponsors>
    <lead_sponsor>
      <agency>Lesaffre International</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Lesaffre International</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the study is to evaluate the effect of the consumption of a food supplement (live&#xD;
      saccharomyces cerevisiae) on lipidic profile in moderate hypercholesterolemic subjects.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>December 2016</start_date>
  <completion_date type="Actual">May 2018</completion_date>
  <primary_completion_date type="Actual">November 2017</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Plasma LDL cholesterol</measure>
    <time_frame>8 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>LDL cholesterol</measure>
    <time_frame>4 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total cholesterol</measure>
    <time_frame>4 weeks, 8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Triglycerides</measure>
    <time_frame>4 weeks, 8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HDL cholesterol</measure>
    <time_frame>4 weeks, 8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apo B</measure>
    <time_frame>4 weeks, 8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apo A1</measure>
    <time_frame>4 weeks, 8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>gamma GT</measure>
    <time_frame>4 weeks, 8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ASAT</measure>
    <time_frame>4 weeks, 8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ALAT</measure>
    <time_frame>4 weeks, 8 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">201</enrollment>
  <condition>Dyslipidemias</condition>
  <arm_group>
    <arm_group_label>Live Saccharomyces cerevisiae</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Live Saccharomyces cerevisiae. 2 capsules per day (1 g).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Yeast cell wall</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Yeast cell wall. 2 capsules a day (700 mg).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Maize starch and magnesium stearate. 2 capsules a day.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Saccharomyces cerevisiae</intervention_name>
    <description>Live Saccharomyces cerevisiae</description>
    <arm_group_label>Live Saccharomyces cerevisiae</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Lynside Wall Basic</intervention_name>
    <description>yeast cell walls</description>
    <arm_group_label>Yeast cell wall</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Maize starch and magnesium stearate</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Moderate hypercholesterolemia (LDL cholesterol between 1.3 and 1.9 g/L) with maximum 1&#xD;
             associated cardiovascular risk factor.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Total cholesterol &gt; 3.5 g/L (on an empty stomach)&#xD;
&#xD;
          -  Triglycerides &gt; 3 g/L (on an empty stomach)&#xD;
&#xD;
          -  Familial hypercholesterolemia (IIa type)&#xD;
&#xD;
          -  Diabete mellitus treated or not&#xD;
&#xD;
          -  Subjects having consumed drugs known for their impact on lipid metabolism (statines,&#xD;
             ezetimibes, colestyramin, fibrate...) in the month before beginning if the study&#xD;
             and/or susceptible to consume such drugs during the study&#xD;
&#xD;
          -  Subjects having consumed food supplements or functional foods known for their impact&#xD;
             on cholesterolemia (phytosterols, phytostanols, policosanols, beta-glucans...) in the&#xD;
             month before the study and/or susceptible to consume such products during the study&#xD;
&#xD;
          -  Subjects having consumed probiotics food supplements in the month before the study&#xD;
             and/or susceptible to consume such products during the study&#xD;
&#xD;
          -  Subjects following a low diet regimen (intakes &lt; 1500 kcal/day) in the month before&#xD;
             the study and/or susceptible to start such a regimen during the study&#xD;
&#xD;
          -  Food behaviour disorders diagnosed&#xD;
&#xD;
          -  Subjects with rare serious diseases (rare digestive diseases, renal failure,&#xD;
             cardiovascular diseases, tumor...) or having endure a serious surgery&#xD;
&#xD;
          -  Subjects having endure bariatric surgery or having a gastric bypass in place&#xD;
&#xD;
          -  Pregnant or lactating women&#xD;
&#xD;
          -  Women willing a pregnancy Excessive alcohol consumption&#xD;
&#xD;
          -  Susceptible to modify their tobacco consumption before the end of the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Institut Pasteur de Lille</name>
      <address>
        <city>Lille</city>
        <zip>59000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>June 2018</verification_date>
  <study_first_submitted>December 2, 2016</study_first_submitted>
  <study_first_submitted_qc>December 12, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 13, 2016</study_first_posted>
  <last_update_submitted>June 11, 2018</last_update_submitted>
  <last_update_submitted_qc>June 11, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">June 12, 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>Dyslipidemias</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02990260
org study id: 2016-A011094-47
nct id: NCT02990260
lead sponsor: 
has dmc: No
The aim of the study is to evaluate the effect of the consumption of a food supplement (live
      saccharomyces cerevisiae) on lipidic profile in moderate hypercholesterolemic subjects.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Plasma LDL cholesterol
time frame: 8 weeks
measure: LDL cholesterol
time frame: 4 weeks
measure: Total cholesterol
time frame: 4 weeks, 8 weeks
measure: Triglycerides
time frame: 4 weeks, 8 weeks
measure: HDL cholesterol
time frame: 4 weeks, 8 weeks
measure: Apo B
time frame: 4 weeks, 8 weeks
measure: Apo A1
time frame: 4 weeks, 8 weeks
measure: gamma GT
time frame: 4 weeks, 8 weeks
measure: ASAT
time frame: 4 weeks, 8 weeks
measure: ALAT
time frame: 4 weeks, 8 weeks
arm group label: Live Saccharomyces cerevisiae
arm group type: Active Comparator
description: Live Saccharomyces cerevisiae. 2 capsules per day (1 g).
arm group label: Yeast cell wall
arm group type: Active Comparator
description: Yeast cell wall. 2 capsules a day (700 mg).
arm group label: Placebo
arm group type: Placebo Comparator
description: Maize starch and magnesium stearate. 2 capsules a day.
intervention type: Dietary Supplement
intervention name: Saccharomyces cerevisiae
description: Live Saccharomyces cerevisiae
arm group label: Live Saccharomyces cerevisiae
intervention type: Dietary Supplement
intervention name: Lynside Wall Basic
description: yeast cell walls
arm group label: Yeast cell wall
intervention type: Dietary Supplement
intervention name: Placebo
description: Maize starch and magnesium stearate
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: France
responsible party type: Sponsor
mesh term: Dyslipidemias
sharing ipd: Undecided