<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/NCT02215694</url>
  </required_header>
  <id_info>
    <org_study_id>probiotics_140801</org_study_id>
    <nct_id>NCT02215694</nct_id>
  </id_info>
  <brief_title>Supplementation of Dual Probiotic Strains Reduced Fasting Triglyceride and Enhanced Apolipoprotein A-V Levels</brief_title>
  <official_title>Supplementation of Dual Probiotic Strains, Lactobacillus Curvatus HY7601 and Lactobacillus Plantarum KY1032, Reduced Fasting Triglyceride and Enhanced Apolipoprotein A-V Levels in Nondiabetic and Hypertriglyceridemic Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yonsei University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yonsei University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the effect of dual probiotic strains containing&#xD;
      Lactobacillus curvatus HY7601 and Lactobacillus plantarum KY1032 on triglyceride and&#xD;
      apolipoprotein A-V.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A randomized, double-blind, placebo-controlled study was conducted on 128 nondiabetic and&#xD;
      hypertriglyceridemic (Plasma Triglyceride, 150-500 mg/dL) subjects. Over a 12 week test&#xD;
      period, the probiotic group consumed 2g of powder daily containing dual probiotic strains,&#xD;
      while the placebo group consumed the same without probiotics.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2012</start_date>
  <completion_date type="Actual">March 2014</completion_date>
  <primary_completion_date type="Actual">March 2014</primary_completion_date>
  <phase>Phase 3</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>Basic Science</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>ApoA5-1131 genotype</measure>
    <time_frame>at baseline</time_frame>
    <description>ApoA5-1131 T&gt;C</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Fasting glucose at baseline and 12-week follow-up</measure>
    <time_frame>12-week follow-up</time_frame>
    <description>Serum fasting glucose (mg/dL)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Insulin at baseline and 12-week follow-up</measure>
    <time_frame>12-week follow-up</time_frame>
    <description>Serum insulin (μIU/dL)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>C-peptide at baseline and 12-week follow-up</measure>
    <time_frame>12-week follow-up</time_frame>
    <description>Serum C-peptide (μEq/L)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apolipoprotein A-V at baseline and 12-week follow-up</measure>
    <time_frame>12-week follow-up</time_frame>
    <description>Plasma apolipoprotein A-V (ng/mL)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Triglyceride at baseline and 12-week follow-up</measure>
    <time_frame>12-week follow-up</time_frame>
    <description>Serum triglyceride (mg/dL)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Free fatty acid at baseline and 12-week follow-up</measure>
    <time_frame>12-week follow-up</time_frame>
    <description>Serum free fatty acid (μEq/L)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>LDL particle size at baseline and 12-week follow-up</measure>
    <time_frame>12-week follow-up</time_frame>
    <description>Plasma LDL particle size (nm)</description>
  </other_outcome>
  <other_outcome>
    <measure>Serum high-sensitivity C-reactive protein at baseline and 12-week follow-up</measure>
    <time_frame>12-week follow-up</time_frame>
    <description>Serum high-sensitivity C-reactive protein (mg/dL)</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">128</enrollment>
  <condition>Hypertriglyceridemia</condition>
  <arm_group>
    <arm_group_label>probiotic group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>consumed 2g of powder daily containing dual probiotics(Lactobacillus curvatus HY7601 and Lactobacillus plantarum KY1032)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>placebo group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>consumed 2g of powder daily without probiotics</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>dual probiotics</intervention_name>
    <description>2g of powder daily containing dual probiotics(Lactobacillus curvatus HY7601 and Lactobacillus plantarum KY1032)</description>
    <arm_group_label>probiotic group</arm_group_label>
    <other_name>probiotic</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>placebo</intervention_name>
    <description>2g of powder daily without probiotics</description>
    <arm_group_label>placebo group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  nondiabetic (plasma fasting glucose, &lt;126mg/dL; 2-hour plasma glucose, &lt;200mg/dL)&#xD;
&#xD;
          -  borderline to moderate hypertriglyceridemia (plasma triglyceride, 150-500 mg/dL)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  lipid-lowering medications use&#xD;
&#xD;
          -  any medications or supplement use&#xD;
&#xD;
          -  any probiotics products use for the past 1 months&#xD;
&#xD;
          -  dyslipidemia&#xD;
&#xD;
          -  diabetes mellitus&#xD;
&#xD;
          -  hypertension&#xD;
&#xD;
          -  liver disease&#xD;
&#xD;
          -  renal disease&#xD;
&#xD;
          -  cardiovascular disease&#xD;
&#xD;
          -  cerebrovascular disease&#xD;
&#xD;
          -  pancreatitis&#xD;
&#xD;
          -  cancer&#xD;
&#xD;
          -  medication or alcohol abuse&#xD;
&#xD;
          -  pregnant or breast feeding&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>24 Years</minimum_age>
    <maximum_age>68 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jong Ho Lee, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Yonsei University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Laboratory of Clinical Nutrigenetics/Nutrigenomics</name>
      <address>
        <city>Seoul</city>
        <zip>120-749</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 2, 2014</study_first_submitted>
  <study_first_submitted_qc>August 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 13, 2014</study_first_posted>
  <last_update_submitted>August 11, 2014</last_update_submitted>
  <last_update_submitted_qc>August 11, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 13, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Apolipoprotein A-V</keyword>
  <keyword>LDL particle size</keyword>
  <keyword>probiotic</keyword>
  <keyword>triglyceride</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertriglyceridemia</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/NCT02215694
org study id: probiotics_140801
nct id: NCT02215694
lead sponsor: 
has dmc: Yes
The purpose of this study is to evaluate the effect of dual probiotic strains containing
      Lactobacillus curvatus HY7601 and Lactobacillus plantarum KY1032 on triglyceride and
      apolipoprotein A-V.
A randomized, double-blind, placebo-controlled study was conducted on 128 nondiabetic and
      hypertriglyceridemic (Plasma Triglyceride, 150-500 mg/dL) subjects. Over a 12 week test
      period, the probiotic group consumed 2g of powder daily containing dual probiotic strains,
      while the placebo group consumed the same without probiotics.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Double (Participant, Investigator)
measure: ApoA5-1131 genotype
time frame: at baseline
description: ApoA5-1131 T>C
measure: Fasting glucose at baseline and 12-week follow-up
time frame: 12-week follow-up
description: Serum fasting glucose (mg/dL)
measure: Insulin at baseline and 12-week follow-up
time frame: 12-week follow-up
description: Serum insulin (μIU/dL)
measure: C-peptide at baseline and 12-week follow-up
time frame: 12-week follow-up
description: Serum C-peptide (μEq/L)
measure: Apolipoprotein A-V at baseline and 12-week follow-up
time frame: 12-week follow-up
description: Plasma apolipoprotein A-V (ng/mL)
measure: Triglyceride at baseline and 12-week follow-up
time frame: 12-week follow-up
description: Serum triglyceride (mg/dL)
measure: Free fatty acid at baseline and 12-week follow-up
time frame: 12-week follow-up
description: Serum free fatty acid (μEq/L)
measure: LDL particle size at baseline and 12-week follow-up
time frame: 12-week follow-up
description: Plasma LDL particle size (nm)
measure: Serum high-sensitivity C-reactive protein at baseline and 12-week follow-up
time frame: 12-week follow-up
description: Serum high-sensitivity C-reactive protein (mg/dL)
arm group label: probiotic group
arm group type: Experimental
description: consumed 2g of powder daily containing dual probiotics(Lactobacillus curvatus HY7601 and Lactobacillus plantarum KY1032)
arm group label: placebo group
arm group type: Placebo Comparator
description: consumed 2g of powder daily without probiotics
intervention type: Dietary Supplement
intervention name: dual probiotics
description: 2g of powder daily containing dual probiotics(Lactobacillus curvatus HY7601 and Lactobacillus plantarum KY1032)
arm group label: probiotic group
other name: probiotic
intervention type: Dietary Supplement
intervention name: placebo
description: 2g of powder daily without probiotics
arm group label: placebo group
criteria: 
gender: All
minimum age: 24 Years
maximum age: 68 Years
healthy volunteers: No
last name: Jong Ho Lee, PhD
role: Principal Investigator
affiliation: Yonsei University
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Hypertriglyceridemia