<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/NCT03826017</url>
  </required_header>
  <id_info>
    <org_study_id>RNO-CF-EG</org_study_id>
    <nct_id>NCT03826017</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of Catechin High Contain Greentea Extract on Improvement of Cognitive Function</brief_title>
  <official_title>A 12 Weeks, Randomized, Double-blind, Placebo-controlled Human Trial to Evaluate the Efficacy and Safety of Catechin High Contain Greentea Extract on Improvement of Cognitive Function</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>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study was the efficacy and safety of Catechin high contain greentea extract on&#xD;
      improvement of Cognitive Function&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study was a 12 weeks, randomized, double-blind, placebo-controlled human trial to&#xD;
      evaluate. 80 subjects were participated in Catechin high contain greentea extract or placebo&#xD;
      group. To evaluate the changes of the evaluation items when Catechin high contain greentea&#xD;
      extract was taken 12 weeks compared with placebo.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 5, 2018</start_date>
  <completion_date type="Actual">October 8, 2019</completion_date>
  <primary_completion_date type="Actual">October 8, 2019</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>Prevention</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes of Visual learning test</measure>
    <time_frame>12 weeks</time_frame>
    <description>Visual learning test was measured in baseline and 12 week.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes of Korean Version of the Montreal Cognitive Assessment(MoCA-K)</measure>
    <time_frame>12 weeks</time_frame>
    <description>Korean Version of the Montreal Cognitive Assessment(MoCA-K) was measured in baseline and 12 week. The cognitive function evaluation using the Montreal Cognitive Assessment(MoCA-K) is a total of 8 items, and evaluates cognitive functions such as time / execution power, vocabulary, memory, attention, sentence, abstraction, delayed recall, and orientation.&#xD;
Time / execution power's total score is 5 points, vocabulary's total score is 3 points, attention's total score is 3 points, sentence's total score is 3 points, abstraction's total score is 2 points, delayed recall's total score is 5 points, orientation's total score is 6 points. It takes about 10 minutes to complete, and the total score is 30 points and total score make sum score. A score of 23 points or more is regarded as normal. If you have less than 6 years of education, add 1 point.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes of Auditory continuous performance test</measure>
    <time_frame>12 weeks</time_frame>
    <description>Auditory continuous performance test was measured in baseline and 12 week.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes of Verbal learning test</measure>
    <time_frame>12 weeks</time_frame>
    <description>Verbal learning test was measured in baseline and 12 week.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes of Visual working memory test</measure>
    <time_frame>12 weeks</time_frame>
    <description>Visual working memory test was measured in baseline and 12 week.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes of Perceived stress scale(PSS)</measure>
    <time_frame>12 weeks</time_frame>
    <description>Perceived stress scale(PSS) was measured in baseline and 12 week. It consists of 10 questions. Each question is evaluated from 0 (none) to 4 (very often), and 4 items (4, 5, 7, 8) are scored back and added to the remaining questions. The duration of the last month should be presented before implementation (if the duration is longer, the predictability is lowered).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes of Beck Depression Inventory(BDI)</measure>
    <time_frame>12 weeks</time_frame>
    <description>Beck Depression Inventory(BDI) was measured in baseline and 12 week. It consists of 21 items including cognitive, emotional, synchronous, and physical symptoms of depression. The total score ranges from 0~63 points for each question. Beck Depression Inventory(BDI) score is 0 ~ 9 points non-depression, 10 ~ 15 is mild depression, 16 ~ 23 is moderate depression, and 24 ~ 63 is severe depression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes of Brain-derived neurotrophic factor(BDNF)</measure>
    <time_frame>12 weeks</time_frame>
    <description>Brain-derived neurotrophic factor(BDNF)(pg/mL) was measured in baseline and 12 week.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes of Total antioxidant status(TAS)</measure>
    <time_frame>12 weeks</time_frame>
    <description>Total antioxidant status(TAS) was measured in baseline and 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>Catechin high contain greentea extract</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Catechin high contain greentea extract for 260 mg/day 12 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo for 12 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Catechin high contain greentea extract</intervention_name>
    <description>Catechin high contain greentea extract 260 mg/day for 12 weeks.</description>
    <arm_group_label>Catechin high contain greentea extract</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo for 12 weeks.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Those who are at least 60 years of age at screening&#xD;
&#xD;
          -  Those who have Korean Mini-Mental Status Examination(K-MMSE) result 25-28 points&#xD;
&#xD;
          -  Those who agree to voluntary participation and to comply with the Notice after fully&#xD;
             hearing and understanding the details of this human trial&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Those with a past history of treatment with Axis I disorder in SCID(Structured&#xD;
             Clinical Interview for DSM-IV) which is a structured clinical interview in the&#xD;
             Diagnostic and Statistical Manual of Mental Disorders at Screening or who have been&#xD;
             treated within the last 3 years&#xD;
&#xD;
          -  Those with alcohol abuse or dependence within the last 3 months&#xD;
&#xD;
          -  Those who have clinically significant following severe illness (Epilepsy, mental&#xD;
             retardation, brain nervous system diseases, endocrine diseases, blood / malignant&#xD;
             tumors, cardiovascular diseases, Crohn's disease, etc.)&#xD;
&#xD;
          -  Those with a history of clinically significant hypersensitivity to green tea&#xD;
&#xD;
          -  Those taking medicines, health functional foods or herbal medicines related to&#xD;
             improvement of cognitive function and memory within 1 month before screening&#xD;
&#xD;
          -  Those who ingested green tea extract's health functional food within 1 month before&#xD;
             screening&#xD;
&#xD;
          -  Those who whole blood donation within 1 months before the first ingestion or Component&#xD;
             blood donation within 2 weeks&#xD;
&#xD;
          -  Those who participate in other human tiral within 3 months&#xD;
&#xD;
          -  Those who shows the following results in the Laboratory test&#xD;
&#xD;
               -  AST, ALT &gt; 3 times upper limit of normal range&#xD;
&#xD;
               -  Other significant laboratory test opinion&#xD;
&#xD;
          -  Those who is deemed unsuitable for participating in the human trial due to other&#xD;
             reasons&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Young-chul Chung, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chonbuk National University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Psychiatry, Chonbuk National University Hospital</name>
      <address>
        <city>Jeonju</city>
        <state>Jeollabuk-do</state>
        <zip>54907</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>January 30, 2019</study_first_submitted>
  <study_first_submitted_qc>January 30, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 1, 2019</study_first_posted>
  <last_update_submitted>July 15, 2020</last_update_submitted>
  <last_update_submitted_qc>July 15, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chonbuk National University Hospital</investigator_affiliation>
    <investigator_full_name>Young Chul Chung</investigator_full_name>
    <investigator_title>Professor of Psychiatry</investigator_title>
  </responsible_party>
  <keyword>Catechin high contain greentea extract</keyword>
  <keyword>Cognitive Function</keyword>
  <!-- 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/NCT03826017
org study id: RNO-CF-EG
nct id: NCT03826017
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study was the efficacy and safety of Catechin high contain greentea extract on
      improvement of Cognitive Function
This study was a 12 weeks, randomized, double-blind, placebo-controlled human trial to
      evaluate. 80 subjects were participated in Catechin high contain greentea extract or placebo
      group. To evaluate the changes of the evaluation items when Catechin high contain greentea
      extract was taken 12 weeks compared with placebo.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Investigator)
measure: Changes of Visual learning test
time frame: 12 weeks
description: Visual learning test was measured in baseline and 12 week.
measure: Changes of Korean Version of the Montreal Cognitive Assessment(MoCA-K)
time frame: 12 weeks
description: Korean Version of the Montreal Cognitive Assessment(MoCA-K) was measured in baseline and 12 week. The cognitive function evaluation using the Montreal Cognitive Assessment(MoCA-K) is a total of 8 items, and evaluates cognitive functions such as time / execution power, vocabulary, memory, attention, sentence, abstraction, delayed recall, and orientation.
Time / execution power's total score is 5 points, vocabulary's total score is 3 points, attention's total score is 3 points, sentence's total score is 3 points, abstraction's total score is 2 points, delayed recall's total score is 5 points, orientation's total score is 6 points. It takes about 10 minutes to complete, and the total score is 30 points and total score make sum score. A score of 23 points or more is regarded as normal. If you have less than 6 years of education, add 1 point.
measure: Changes of Auditory continuous performance test
time frame: 12 weeks
description: Auditory continuous performance test was measured in baseline and 12 week.
measure: Changes of Verbal learning test
time frame: 12 weeks
description: Verbal learning test was measured in baseline and 12 week.
measure: Changes of Visual working memory test
time frame: 12 weeks
description: Visual working memory test was measured in baseline and 12 week.
measure: Changes of Perceived stress scale(PSS)
time frame: 12 weeks
description: Perceived stress scale(PSS) was measured in baseline and 12 week. It consists of 10 questions. Each question is evaluated from 0 (none) to 4 (very often), and 4 items (4, 5, 7, 8) are scored back and added to the remaining questions. The duration of the last month should be presented before implementation (if the duration is longer, the predictability is lowered).
measure: Changes of Beck Depression Inventory(BDI)
time frame: 12 weeks
description: Beck Depression Inventory(BDI) was measured in baseline and 12 week. It consists of 21 items including cognitive, emotional, synchronous, and physical symptoms of depression. The total score ranges from 0~63 points for each question. Beck Depression Inventory(BDI) score is 0 ~ 9 points non-depression, 10 ~ 15 is mild depression, 16 ~ 23 is moderate depression, and 24 ~ 63 is severe depression.
measure: Changes of Brain-derived neurotrophic factor(BDNF)
time frame: 12 weeks
description: Brain-derived neurotrophic factor(BDNF)(pg/mL) was measured in baseline and 12 week.
measure: Changes of Total antioxidant status(TAS)
time frame: 12 weeks
description: Total antioxidant status(TAS) was measured in baseline and 12 week.
arm group label: Catechin high contain greentea extract
arm group type: Experimental
description: Catechin high contain greentea extract for 260 mg/day 12 weeks.
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo for 12 weeks.
intervention type: Dietary Supplement
intervention name: Catechin high contain greentea extract
description: Catechin high contain greentea extract 260 mg/day for 12 weeks.
arm group label: Catechin high contain greentea extract
intervention type: Dietary Supplement
intervention name: Placebo
description: Placebo for 12 weeks.
arm group label: Placebo
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Young-chul Chung, MD
role: Principal Investigator
affiliation: Chonbuk National University Hospital
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Chonbuk National University Hospital
investigator full name: Young Chul Chung
investigator title: Professor of Psychiatry