<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/NCT01734200</url>
  </required_header>
  <id_info>
    <org_study_id>INs-MF-ERIO</org_study_id>
    <nct_id>NCT01734200</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of Eriobotyra Japonica Lindley Extract on Improvement of Cognitive Function</brief_title>
  <official_title>Efficacy and Safety of Eriobotyra Japonica Lindley Extract on Improvement of Cognitive Function: a 12 Week, Randomized Double-blind, Placebo-controlled Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chonbuk National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chonbuk National University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators performed a 12-week, randomized, double-blind, placebo-controlled human&#xD;
      trial to evaluate the efficacy and safety of Eriobotyra Japonica Lindley Extract on&#xD;
      improvement of Memory Function. The investigators measured decrement of improvement of Memory&#xD;
      Function, including K-MMSE, Rey-Kim Memory Test, BCRS, and PRMQ, and monitored their blood&#xD;
      pressure.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">November 2013</completion_date>
  <primary_completion_date type="Actual">September 2013</primary_completion_date>
  <phase>Phase 2/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>Prevention</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in K-MMSE(Korean Mini-Mental State Examination)</measure>
    <time_frame>12 weeks</time_frame>
    <description>K-MMSE(Korean Mini-Mental State Examination) was measured in study visit 1(0 week) and visit 3(12 week).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in Rey-Kim Memory Test</measure>
    <time_frame>12 weeks</time_frame>
    <description>Rey-Kim Memory Test was measured in study visit 1(0 week) and visit 3(12 week).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in BCRS(Brief Cognitive Rating Scale)</measure>
    <time_frame>12 weeks</time_frame>
    <description>BCRS(Brief Cognitive Rating Scale) was measured in study visit 1(0 week) and visit 3(12 week).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in PRMQ(Prospective and retrospective memory questionnaire)</measure>
    <time_frame>12 weeks</time_frame>
    <description>PRMQ(Prospective and retrospective memory questionnaire) was measured in study visit 1(0 week) and visit 3(12 week).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in STAI(State-trait anxiety inventory)</measure>
    <time_frame>12 weeks</time_frame>
    <description>STAI(State-trait anxiety inventory) was measured in study visit 1(0 week) and visit 3(12 week).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in BDNF(Brain derived neurotrophic factor)</measure>
    <time_frame>12 weeks</time_frame>
    <description>BDNF(Brain derived neurotrophic factor) was measured in study visit 1(0 week) and visit 3(12 week).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Cognitive Function</condition>
  <arm_group>
    <arm_group_label>Eriobotyra Japonica Lindley Extract</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Eriobotyra Japonica Lindley Extract</intervention_name>
    <description>Eriobotyra Japonica Lindley Extract (1.5g/day)</description>
    <arm_group_label>Eriobotyra Japonica Lindley Extract</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo (1.5g/day)</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Males and females 16-19 years old&#xD;
&#xD;
          -  Weight within ±30% of ideal body weight&#xD;
&#xD;
          -  Able to give informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Allergic or hypersensitive to any of the ingredients in the test products&#xD;
&#xD;
          -  History of reaction to any of the test products or of gastrointestinal diseases such&#xD;
             as Crohn's disease or gastrointestinal surgery&#xD;
&#xD;
          -  History of alcohol or substance abuse&#xD;
&#xD;
          -  Participation in any other clinical trials within past 2 months&#xD;
&#xD;
          -  Laboratory test, medical or psychological conditions deemed by the investigators to&#xD;
             interfere with successful participation in the study&#xD;
&#xD;
          -  Pregnant or lactating women etc.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>19 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Clinical Trial Center for Functional Foods; Chonbuk National University Hospital</name>
      <address>
        <city>Jeonju</city>
        <state>Jeollabuk-do</state>
        <zip>560-822</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>July 2015</verification_date>
  <study_first_submitted>November 22, 2012</study_first_submitted>
  <study_first_submitted_qc>November 22, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 27, 2012</study_first_posted>
  <last_update_submitted>July 13, 2015</last_update_submitted>
  <last_update_submitted_qc>July 13, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 15, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chonbuk National University Hospital</investigator_affiliation>
    <investigator_full_name>Soo-Wan Chae</investigator_full_name>
    <investigator_title>Principal Investigator, Clinical Trial Center for Functional Foods</investigator_title>
  </responsible_party>
  <!-- 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/NCT01734200
org study id: INs-MF-ERIO
nct id: NCT01734200
lead sponsor: 
has dmc: Yes
The investigators performed a 12-week, randomized, double-blind, placebo-controlled human
      trial to evaluate the efficacy and safety of Eriobotyra Japonica Lindley Extract on
      improvement of Memory Function. The investigators measured decrement of improvement of Memory
      Function, including K-MMSE, Rey-Kim Memory Test, BCRS, and PRMQ, and monitored their blood
      pressure.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Investigator)
measure: Changes in K-MMSE(Korean Mini-Mental State Examination)
time frame: 12 weeks
description: K-MMSE(Korean Mini-Mental State Examination) was measured in study visit 1(0 week) and visit 3(12 week).
measure: Changes in Rey-Kim Memory Test
time frame: 12 weeks
description: Rey-Kim Memory Test was measured in study visit 1(0 week) and visit 3(12 week).
measure: Changes in BCRS(Brief Cognitive Rating Scale)
time frame: 12 weeks
description: BCRS(Brief Cognitive Rating Scale) was measured in study visit 1(0 week) and visit 3(12 week).
measure: Changes in PRMQ(Prospective and retrospective memory questionnaire)
time frame: 12 weeks
description: PRMQ(Prospective and retrospective memory questionnaire) was measured in study visit 1(0 week) and visit 3(12 week).
measure: Changes in STAI(State-trait anxiety inventory)
time frame: 12 weeks
description: STAI(State-trait anxiety inventory) was measured in study visit 1(0 week) and visit 3(12 week).
measure: Changes in BDNF(Brain derived neurotrophic factor)
time frame: 12 weeks
description: BDNF(Brain derived neurotrophic factor) was measured in study visit 1(0 week) and visit 3(12 week).
arm group label: Eriobotyra Japonica Lindley Extract
arm group type: Experimental
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Dietary Supplement
intervention name: Eriobotyra Japonica Lindley Extract
description: Eriobotyra Japonica Lindley Extract (1.5g/day)
arm group label: Eriobotyra Japonica Lindley Extract
intervention type: Dietary Supplement
intervention name: Placebo
description: Placebo (1.5g/day)
arm group label: Placebo
criteria: 
gender: All
minimum age: 16 Years
maximum age: 19 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Chonbuk National University Hospital
investigator full name: Soo-Wan Chae
investigator title: Principal Investigator, Clinical Trial Center for Functional Foods