<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/NCT04431843</url>
  </required_header>
  <id_info>
    <org_study_id>KIOST-CF-SM2</org_study_id>
    <nct_id>NCT04431843</nct_id>
  </id_info>
  <brief_title>the Efficacy and Safety of Spirulina Maxima 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 Spirulina Maxima 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 evaluate the efficacy and safety of Spirulina maxima extract on the&#xD;
      improvement of Cognitive Function&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study was 12 weeks, randomized, double-blind, placebo-controlled human trial to&#xD;
      evaluate. 80 subjects participated in Spirulina maxima extract or placebo group. To evaluate&#xD;
      the changes in the evaluation items when Spirulina maxima extract was taken 12 weeks compared&#xD;
      with placebo.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 17, 2020</start_date>
  <completion_date type="Actual">November 26, 2020</completion_date>
  <primary_completion_date type="Actual">November 26, 2020</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 of CNT(Computerized neurocognitive function test) was measured in baseline and 12 week. And changes of result from the test were utilized.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes of Visual working memory test</measure>
    <time_frame>12 weeks</time_frame>
    <description>Visual working memory test of WMT(working memory tasks) was measured in baseline and 12 week. And changes of result from the test were utilized.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes of Verbal learning test</measure>
    <time_frame>12 weeks</time_frame>
    <description>Verbal learning test of CNT(Computerized neurocognitive function test) was measured in baseline and 12 week. And changes of result from the test were utilized.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>MoCA-K; Korean Version of the Montreal Cognitive Assessment</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 Auditory continuous performance test</measure>
    <time_frame>12 weeks</time_frame>
    <description>Auditory continuous performance test of CNT(Computerized neurocognitive function test) was measured in baseline and 12 week. And changes of result from the test were utilized.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>BDNF; Brain-derived neurotrophic factor</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 TAS(Total antioxidant status)</measure>
    <time_frame>12 weeks</time_frame>
    <description>Total antioxidant status(TAS) was measured in baseline and 12 week. And changes of result from the test were utilized.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Cognitive Function</condition>
  <arm_group>
    <arm_group_label>Spirulina maxima extract</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Spirulina maxima extract for 1.5 g/day</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Spirulina maxima extract for 0 g/day</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Spirulina maxima extract</intervention_name>
    <description>once a day for 2 p.o., after breakfast and dinner(1.52 g/day, Spirulina maxima extract for 1.5 g/day) for 12 week</description>
    <arm_group_label>Spirulina maxima extract</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>once a day for 2 p.o., after breakfast and dinner(1.52 g/day, Spirulina maxima extract for 0 g/day) for 12 week</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Persons who are at least 60 years of age at screening&#xD;
&#xD;
          -  Persons who have Korean Mini-Mental Status Examination(K-MMSE) result in 25-28 points&#xD;
&#xD;
          -  Persons 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;
          -  Patients 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;
          -  Patients with BMI(Body Mass Index)&lt;18.5 kg/m^ or 35 kg/m^≤BMI(Body Mass Index)&#xD;
&#xD;
          -  Patients with alcohol abuse or dependence within the last 3 months&#xD;
&#xD;
          -  Patients who have clinically significant following severe illness (i.e.,&#xD;
             Cardiovascular, endocrine system, immune system, respiratory system, hepatobiliary&#xD;
             system, kidney and urinary system, neuropsychiatric, musculoskeletal, inflammatory,&#xD;
             blood and tumors, gastrointestinal diseases, etc.)&#xD;
&#xD;
          -  Patients with a history of clinically significant hypersensitivity to Spirulina Maxima&#xD;
&#xD;
          -  Patients taking medicines, health functional foods or herbal medicines related to the&#xD;
             improvement of cognitive function and memory within 1 month before screening&#xD;
&#xD;
          -  Patients who ingested Spirulina Maxima extract's health functional food within 1 month&#xD;
             before screening&#xD;
&#xD;
          -  Patients who whole blood donation within 1 months before the first ingestion or&#xD;
             Component blood donation within 2 weeks&#xD;
&#xD;
          -  Patients who participate in another human trial within 3 months&#xD;
&#xD;
          -  Those who show the following results in the Laboratory test&#xD;
&#xD;
               -  AST, ALT &gt; 3 times upper limit of the normal range&#xD;
&#xD;
               -  Other significant laboratory test opinion&#xD;
&#xD;
          -  Patients who are 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>February 2023</verification_date>
  <study_first_submitted>June 9, 2020</study_first_submitted>
  <study_first_submitted_qc>June 11, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>February 8, 2023</last_update_submitted>
  <last_update_submitted_qc>February 8, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 10, 2023</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>Spirulina maxima 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/NCT04431843
org study id: KIOST-CF-SM2
nct id: NCT04431843
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study was the evaluate the efficacy and safety of Spirulina maxima extract on the
      improvement of Cognitive Function
This study was 12 weeks, randomized, double-blind, placebo-controlled human trial to
      evaluate. 80 subjects participated in Spirulina maxima extract or placebo group. To evaluate
      the changes in the evaluation items when Spirulina maxima 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 of CNT(Computerized neurocognitive function test) was measured in baseline and 12 week. And changes of result from the test were utilized.
measure: Changes of Visual working memory test
time frame: 12 weeks
description: Visual working memory test of WMT(working memory tasks) was measured in baseline and 12 week. And changes of result from the test were utilized.
measure: Changes of Verbal learning test
time frame: 12 weeks
description: Verbal learning test of CNT(Computerized neurocognitive function test) was measured in baseline and 12 week. And changes of result from the test were utilized.
measure: MoCA-K; Korean Version of the Montreal Cognitive Assessment
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 Auditory continuous performance test
time frame: 12 weeks
description: Auditory continuous performance test of CNT(Computerized neurocognitive function test) was measured in baseline and 12 week. And changes of result from the test were utilized.
measure: BDNF; Brain-derived neurotrophic factor
time frame: 12 weeks
description: Brain-derived neurotrophic factor(BDNF)(pg/mL) was measured in baseline and 12 week.
measure: Changes of TAS(Total antioxidant status)
time frame: 12 weeks
description: Total antioxidant status(TAS) was measured in baseline and 12 week. And changes of result from the test were utilized.
arm group label: Spirulina maxima extract
arm group type: Experimental
description: Spirulina maxima extract for 1.5 g/day
arm group label: Placebo
arm group type: Placebo Comparator
description: Spirulina maxima extract for 0 g/day
intervention type: Dietary Supplement
intervention name: Spirulina maxima extract
description: once a day for 2 p.o., after breakfast and dinner(1.52 g/day, Spirulina maxima extract for 1.5 g/day) for 12 week
arm group label: Spirulina maxima extract
intervention type: Dietary Supplement
intervention name: Placebo
description: once a day for 2 p.o., after breakfast and dinner(1.52 g/day, Spirulina maxima extract for 0 g/day) for 12 week
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