<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/NCT03826121</url>
  </required_header>
  <id_info>
    <org_study_id>KH_CF_SE</org_study_id>
    <nct_id>NCT03826121</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of Sesame Oil Cake 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 Sesame Oil Cake 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 Sesame oil cake extract on improvement of Cognitive&#xD;
      Function&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study was a 12 weeks, randomized, double-blind, placebo-controlled human trial to&#xD;
      evaluate. 70 subjects were participated in Sesame Oil Cake Extract or placebo group. To&#xD;
      evaluate the changes of the evaluation items when Sesame Oil Cake Extract was taken three&#xD;
      times a day compared with placebo.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 15, 2017</start_date>
  <completion_date type="Actual">August 10, 2018</completion_date>
  <primary_completion_date type="Actual">August 10, 2018</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 weeks.</description>
  </primary_outcome>
  <primary_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 weeks.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes of Verbal learning test</measure>
    <time_frame>12 weeks</time_frame>
    <description>Verbal learning test was measured in baseline and 12 weeks.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes of the Montreal Cognitive Assessment(MoCA-K)</measure>
    <time_frame>12 weeks</time_frame>
    <description>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.&#xD;
It takes about 10 minutes to complete, and the score is 30 points. A score of 23 points or more is regarded as normal. If you have less than 6 years of education, add 1 point.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes of beta-amyloid</measure>
    <time_frame>12 weeks</time_frame>
    <description>Beta-amyloid(pg/mL) was measured in baseline and 12 weeks.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes of Oxidation index(8-OHdG)</measure>
    <time_frame>12 weeks</time_frame>
    <description>Oxidation index(8-OHdG)(ng/mL) was measured in baseline and 12 weeks.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">70</enrollment>
  <condition>Cognitive Function</condition>
  <arm_group>
    <arm_group_label>Sesame Oil Cake Extract</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Sesame Oil Cake Extract 1.5 g/day for 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>Sesame Oil Cake Extract</intervention_name>
    <description>Sesame Oil Cake Extract 1.5 g/day for 12 weeks.</description>
    <arm_group_label>Sesame Oil Cake 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 word list memory / recollection/ recognition test scores of CERAD -K&#xD;
             decrease 1-2 SD number of normal value&#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 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 take any prescription medicines or herbal medicines within 2 weeks before&#xD;
             the first ingestion date or take any OTC or vitamin preparations within 1 week&#xD;
&#xD;
          -  Those who participate in other human trial within 2 months before the first ingestion&#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 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>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>July 2019</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 24, 2019</last_update_submitted>
  <last_update_submitted_qc>July 24, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 25, 2019</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>Cognitive Function</keyword>
  <keyword>Sesam Esamesame Oil Cake</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/NCT03826121
org study id: KH_CF_SE
nct id: NCT03826121
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study was the efficacy and safety of Sesame oil cake extract on improvement of Cognitive
      Function
This study was a 12 weeks, randomized, double-blind, placebo-controlled human trial to
      evaluate. 70 subjects were participated in Sesame Oil Cake Extract or placebo group. To
      evaluate the changes of the evaluation items when Sesame Oil Cake Extract was taken three
      times a day 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 weeks.
measure: Changes of Visual working memory test
time frame: 12 weeks
description: Visual working memory test was measured in baseline and 12 weeks.
measure: Changes of Verbal learning test
time frame: 12 weeks
description: Verbal learning test was measured in baseline and 12 weeks.
measure: Changes of the Montreal Cognitive Assessment(MoCA-K)
time frame: 12 weeks
description: 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.
It takes about 10 minutes to complete, and the score is 30 points. 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 beta-amyloid
time frame: 12 weeks
description: Beta-amyloid(pg/mL) was measured in baseline and 12 weeks.
measure: Changes of Oxidation index(8-OHdG)
time frame: 12 weeks
description: Oxidation index(8-OHdG)(ng/mL) was measured in baseline and 12 weeks.
arm group label: Sesame Oil Cake Extract
arm group type: Experimental
description: Sesame Oil Cake Extract 1.5 g/day for 12 weeks
arm group label: Placebo
arm group type: Placebo Comparator
description: placebo for 12 weeks
intervention type: Dietary Supplement
intervention name: Sesame Oil Cake Extract
description: Sesame Oil Cake Extract 1.5 g/day for 12 weeks.
arm group label: Sesame Oil Cake 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