xml: <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/NCT05962008</url>
    </required_header>
    <id_info>
      <org_study_id>06788-0019-10</org_study_id>
      <nct_id>NCT05962008</nct_id>
    </id_info>
    <brief_title>Effects of Consumption of Phosphatidylserine on the Cognitive Function</brief_title>
    <official_title>Effects of Consumption of Phosphatidylserine on the Cognitive Function: a Randomized, Placebo-controlled, Double-blind, Parallel-group Comparison Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Orthomedico Inc.</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>ECA Healthcare Inc.</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Orthomedico Inc.</source>
    <oversight_info>
      <has_dmc>Yes</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>
        The main objective of this trial is to verify the effects of consumption of&#xD;
        phosphatidylserine for 12 weeks on the cognitive function in healthy Japanese subjects.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        In this study, the investigators will evaluate the cognitive function before and after the&#xD;
        intervention. The groups to be compared are omega-3-phosphatidylserine derived from herring&#xD;
        roe, phosphatidylserine derived from soybean, and a placebo.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">July 19, 2023</start_date>
    <completion_date type="Anticipated">March 11, 2024</completion_date>
    <primary_completion_date type="Anticipated">March 11, 2024</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>Treatment</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>The measured value of the standardized score of composite memory at Week 12</measure>
      <time_frame>Week 12</time_frame>
      <description>Verbal Memory (VBM) test and Visual Memory (VIM) test are measured using Cognitrax® which is powered by CNS Vital Signs®, a neurocognitive test system. The standardized score of composite memory is calculated from results of these two tests. This score has been normalized with a mean of 100 and a standard deviation of 15 based on age-matched reference data. Higher scores are always better.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>The amount of change of the standardized score of composite memory between Base line and Week 12</measure>
      <time_frame>Base line and Week 12</time_frame>
      <description>VBM test and VIM test are measured using Cognitrax® which is powered by CNS Vital Signs®, a neurocognitive test system. The standardized score of composite memory is calculated from results of these two tests. This score has been normalized with a mean of 100 and a standard deviation of 15 based on age-matched reference data. Higher scores are always better.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The measured value of the standardized score of neurocognition index (NCI) at Week 12</measure>
      <time_frame>Week 12</time_frame>
      <description>Seven neurocognitive tests {VBM, VIM, Finger Tapping (FTT), Symbol Digit Coding (SDC), Stroop Test (ST), Shifting Attention (SAT), and Continuous Performance (CPT)} are measured using Cognitrax® which is powered by CNS Vital Signs®, a neurocognitive test system. The standardized score of NCI is calculated from results of these seven tests. This score has been normalized with a mean of 100 and a standard deviation of 15 based on age-matched reference data. Higher scores are always better.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The amount of change of the standardized score of NCI between Base line and Week 12</measure>
      <time_frame>Base line and Week 12</time_frame>
      <description>Seven neurocognitive tests {VBM, VIM, FTT, SDC, ST, SAT, and CPT} are measured using Cognitrax® which is powered by CNS Vital Signs®, a neurocognitive test system. The standardized score of NCI is calculated from results of these seven tests. This score has been normalized with a mean of 100 and a standard deviation of 15 based on age-matched reference data. Higher scores are always better.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The measured value of the standardized score of verbal memory at Week 12</measure>
      <time_frame>Week 12</time_frame>
      <description>VBM test is measured using Cognitrax® which is powered by CNS Vital Signs®, a neurocognitive test system. The standardized score of verbal memory is calculated from the result of this test. This score has been normalized with a mean of 100 and a standard deviation of 15 based on age-matched reference data. Higher scores are always better.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The amount of change of the standardized score of verbal memory between Base line and Week 12</measure>
      <time_frame>Base line and Week 12</time_frame>
      <description>VBM test is measured using Cognitrax® which is powered by CNS Vital Signs®, a neurocognitive test system. The standardized score of verbal memory is calculated from the result of this test. This score has been normalized with a mean of 100 and a standard deviation of 15 based on age-matched reference data. Higher scores are always better.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The measured value of the standardized score of visual memory at Week 12</measure>
      <time_frame>Week 12</time_frame>
      <description>VIM test is measured using Cognitrax® which is powered by CNS Vital Signs®, a neurocognitive test system. The standardized score of visual memory is calculated from the result of this test. This score has been normalized with a mean of 100 and a standard deviation of 15 based on age-matched reference data. Higher scores are always better.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The amount of change of the standardized score of visual memory between Base line and Week 12</measure>
      <time_frame>Base line and Week 12</time_frame>
      <description>VIM test is measured using Cognitrax® which is powered by CNS Vital Signs®, a neurocognitive test system. The standardized score of visual memory is calculated from the result of this test. This score has been normalized with a mean of 100 and a standard deviation of 15 based on age-matched reference data. Higher scores are always better.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The measured value of the standardized score of psychomotor speed at Week 12</measure>
      <time_frame>Week 12</time_frame>
      <description>FTT test and SDC test are measured using Cognitrax® which is powered by CNS Vital Signs®, a neurocognitive test system. The standardized score of psychomotor speed is calculated from results of these two tests. This score has been normalized with a mean of 100 and a standard deviation of 15 based on age-matched reference data. Higher scores are always better.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The amount of change of the standardized score of psychomotor speed between Base line and Week 12</measure>
      <time_frame>Base line and Week 12</time_frame>
      <description>FTT test and SDC test are measured using Cognitrax® which is powered by CNS Vital Signs®, a neurocognitive test system. The standardized score of psychomotor speed is calculated from results of these two tests. This score has been normalized with a mean of 100 and a standard deviation of 15 based on age-matched reference data. Higher scores are always better.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The measured value of the standardized score of reaction time at Week 12</measure>
      <time_frame>Week 12</time_frame>
      <description>ST test is measured using Cognitrax® which is powered by CNS Vital Signs®, a neurocognitive test system. The standardized score of reaction time is calculated from the result of this test. This score has been normalized with a mean of 100 and a standard deviation of 15 based on age-matched reference data. Higher scores are always better.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The amount of change of the standardized score of reaction time between Base line and Week 12</measure>
      <time_frame>Base line and Week 12</time_frame>
      <description>ST test is measured using Cognitrax® which is powered by CNS Vital Signs®, a neurocognitive test system. The standardized score of reaction time is calculated from the result of this test. This score has been normalized with a mean of 100 and a standard deviation of 15 based on age-matched reference data. Higher scores are always better.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The measured value of the standardized score of complex attention at Week 12</measure>
      <time_frame>Week 12</time_frame>
      <description>ST test, SAT test, and CPT test are measured using Cognitrax® which is powered by CNS Vital Signs®, a neurocognitive test system. The standardized score of complex attention is calculated from results of these three tests. This score has been normalized with a mean of 100 and a standard deviation of 15 based on age-matched reference data. Higher scores are always better.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The amount of change of the standardized score of complex attention between Base line and Week 12</measure>
      <time_frame>Base line and Week 12</time_frame>
      <description>ST test, SAT test, and CPT test are measured using Cognitrax® which is powered by CNS Vital Signs®, a neurocognitive test system. The standardized score of complex attention is calculated from results of these three tests. This score has been normalized with a mean of 100 and a standard deviation of 15 based on age-matched reference data. Higher scores are always better.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The measured value of the standardized score of cognitive flexibility at Week 12</measure>
      <time_frame>Week 12</time_frame>
      <description>ST test and SAT test are measured using Cognitrax® which is powered by CNS Vital Signs®, a neurocognitive test system. The standardized score of cognitive flexibility is calculated from results of these two tests. This score has been normalized with a mean of 100 and a standard deviation of 15 based on age-matched reference data. Higher scores are always better.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The amount of change of the standardized score of cognitive flexibility between Base line and Week 12</measure>
      <time_frame>Base line and Week 12</time_frame>
      <description>ST test and SAT test are measured using Cognitrax® which is powered by CNS Vital Signs®, a neurocognitive test system. The standardized score of cognitive flexibility is calculated from results of these two tests. This score has been normalized with a mean of 100 and a standard deviation of 15 based on age-matched reference data. Higher scores are always better.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The measured value of the standardized score of processing speed at Week 12</measure>
      <time_frame>Week 12</time_frame>
      <description>SDC test is measured using Cognitrax® which is powered by CNS Vital Signs®, a neurocognitive test system. The standardized score of processing speed is calculated from the result of this test. This score has been normalized with a mean of 100 and a standard deviation of 15 based on age-matched reference data. Higher scores are always better.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The amount of change of the standardized score of processing speed between Base line and Week 12</measure>
      <time_frame>Base line and Week 12</time_frame>
      <description>SDC test is measured using Cognitrax® which is powered by CNS Vital Signs®, a neurocognitive test system. The standardized score of processing speed is calculated from the result of this test. This score has been normalized with a mean of 100 and a standard deviation of 15 based on age-matched reference data. Higher scores are always better.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The measured value of the standardized score of executive function at Week 12</measure>
      <time_frame>Week 12</time_frame>
      <description>SAT test is measured using Cognitrax® which is powered by CNS Vital Signs®, a neurocognitive test system. The standardized score of executive function is calculated from the result of this test. This score has been normalized with a mean of 100 and a standard deviation of 15 based on age-matched reference data. Higher scores are always better.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The amount of change of the standardized score of executive function between Base line and Week 12</measure>
      <time_frame>Base line and Week 12</time_frame>
      <description>SAT test is measured using Cognitrax® which is powered by CNS Vital Signs®, a neurocognitive test system. The standardized score of executive function is calculated from the result of this test. This score has been normalized with a mean of 100 and a standard deviation of 15 based on age-matched reference data. Higher scores are always better.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The measured value of the standardized score of social acuity at Week 12</measure>
      <time_frame>Week 12</time_frame>
      <description>Perception of Emotions (POET) test is measured using Cognitrax® which is powered by CNS Vital Signs®, a neurocognitive test system. The standardized score of social acuity is calculated from the result of this test. This score has been normalized with a mean of 100 and a standard deviation of 15 based on age-matched reference data. Higher scores are always better.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The amount of change of the standardized score of social acuity between Base line and Week 12</measure>
      <time_frame>Base line and Week 12</time_frame>
      <description>POET test is measured using Cognitrax® which is powered by CNS Vital Signs®, a neurocognitive test system. The standardized score of social acuity is calculated from the result of this test. This score has been normalized with a mean of 100 and a standard deviation of 15 based on age-matched reference data. Higher scores are always better.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The measured value of the standardized score of reasoning at Week 12</measure>
      <time_frame>Week 12</time_frame>
      <description>Non-Verbal Reasoning (NVRT) test is measured using Cognitrax® which is powered by CNS Vital Signs®, a neurocognitive test system. The standardized score of reasoning is calculated from the result of this test. This score has been normalized with a mean of 100 and a standard deviation of 15 based on age-matched reference data. Higher scores are always better.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The amount of change of the standardized score of reasoning between Base line and Week 12</measure>
      <time_frame>Base line and Week 12</time_frame>
      <description>NVRT test is measured using Cognitrax® which is powered by CNS Vital Signs®, a neurocognitive test system. The standardized score of reasoning is calculated from the result of this test. This score has been normalized with a mean of 100 and a standard deviation of 15 based on age-matched reference data. Higher scores are always better.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The measured value of the standardized score of working memory at Week 12</measure>
      <time_frame>Week 12</time_frame>
      <description>4-Part Continuous Performance (FPCPT) test is measured using Cognitrax® which is powered by CNS Vital Signs®, a neurocognitive test system. The standardized score of working memory is calculated from the result of this test. This score has been normalized with a mean of 100 and a standard deviation of 15 based on age-matched reference data. Higher scores are always better.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The amount of change of the standardized score of working memory between Base line and Week 12</measure>
      <time_frame>Base line and Week 12</time_frame>
      <description>FPCPT test is measured using Cognitrax® which is powered by CNS Vital Signs®, a neurocognitive test system. The standardized score of working memory is calculated from the result of this test. This score has been normalized with a mean of 100 and a standard deviation of 15 based on age-matched reference data. Higher scores are always better.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The measured value of the standardized score of sustained attention at Week 12</measure>
      <time_frame>Week 12</time_frame>
      <description>FPCPT test is measured using Cognitrax® which is powered by CNS Vital Signs®, a neurocognitive test system. The standardized score of sustained attention is calculated from the result of this test. This score has been normalized with a mean of 100 and a standard deviation of 15 based on age-matched reference data. Higher scores are always better.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The amount of change of the standardized score of sustained attention between Base line and Week 12</measure>
      <time_frame>Base line and Week 12</time_frame>
      <description>FPCPT test is measured using Cognitrax® which is powered by CNS Vital Signs®, a neurocognitive test system. The standardized score of sustained attention is calculated from the result of this test. This score has been normalized with a mean of 100 and a standard deviation of 15 based on age-matched reference data. Higher scores are always better.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The measured value of the standardized score of simple attention at Week 12</measure>
      <time_frame>Week 12</time_frame>
      <description>CPT test is measured using Cognitrax® which is powered by CNS Vital Signs®, a neurocognitive test system. The standardized score of simple attention is calculated from the result of this test. This score has been normalized with a mean of 100 and a standard deviation of 15 based on age-matched reference data. Higher scores are always better.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The amount of change of the standardized score of simple attention between Base line and Week 12</measure>
      <time_frame>Base line and Week 12</time_frame>
      <description>CPT test is measured using Cognitrax® which is powered by CNS Vital Signs®, a neurocognitive test system. The standardized score of simple attention is calculated from the result of this test. This score has been normalized with a mean of 100 and a standard deviation of 15 based on age-matched reference data. Higher scores are always better.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The measured value of the standardized score of motor speed at Week 12</measure>
      <time_frame>Week 12</time_frame>
      <description>FTT test is measured using Cognitrax® which is powered by CNS Vital Signs®, a neurocognitive test system. The standardized score of motor speed is calculated from the result of this test. This score has been normalized with a mean of 100 and a standard deviation of 15 based on age-matched reference data. Higher scores are always better.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The amount of change of the standardized score of motor speed between Base line and Week 12</measure>
      <time_frame>Base line and Week 12</time_frame>
      <description>FTT test is measured using Cognitrax® which is powered by CNS Vital Signs®, a neurocognitive test system. The standardized score of motor speed is calculated from the result of this test. This score has been normalized with a mean of 100 and a standard deviation of 15 based on age-matched reference data. Higher scores are always better.</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">114</enrollment>
    <condition>Healthy Japanese Subjects</condition>
    <arm_group>
      <arm_group_label>Omega-3-phosphatidylserine derived from herring roe</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Take 300 mg/day of omega-3-phosphatidylserine derived from herring roe.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Phosphatidylserine derived from soybean</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Take 300 mg/day of phosphatidylserine derived from soybean.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Take 0 mg/day of phosphatidylserine.</description>
    </arm_group>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>DHAPS® product</intervention_name>
      <description>Take 4 capsules per day after breakfast with warm water.</description>
      <arm_group_label>Omega-3-phosphatidylserine derived from herring roe</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>BioPS® product</intervention_name>
      <description>Take 4 capsules per day after breakfast with warm water.</description>
      <arm_group_label>Phosphatidylserine derived from soybean</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>Take 4 capsules per day after breakfast with warm water.</description>
      <arm_group_label>Placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Japanese&#xD;
  &#xD;
            2. Male and female&#xD;
  &#xD;
            3. Subjects aged 35-65&#xD;
  &#xD;
            4. Healthy subjects&#xD;
  &#xD;
            5. Subjects who notice a decline in memory&#xD;
  &#xD;
            6. Subjects whose scoring of Mini Mental State Examination (MMSE) is 24 or more&#xD;
  &#xD;
            7. Subjects who met the inclusion criteria 1. ~ 6. and have relatively low standardized&#xD;
               score in composite memory measured using Cognitrax at Scr (Selection of those with&#xD;
               relatively low standardized scores will be conducted in blocks of &quot;Subjects aged 50 or&#xD;
               over&quot; and &quot;Subjects aged under 50&quot;)&#xD;
  &#xD;
            8. Subjects who are judged as eligible to participate in the study by the physician&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Subjects undergoing medical treatment or having a medical history of malignant tumor,&#xD;
               heart failure, or myocardial infarction&#xD;
  &#xD;
            2. Subjects carrying a pacemaker or an implantable cardioverter defibrillator (ICD)&#xD;
  &#xD;
            3. Subjects undergoing treatment for any of the following chronic diseases: cardiac&#xD;
               arrhythmia, liver disease, kidney disease, cerebrovascular disorder, rheumatism,&#xD;
               diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases&#xD;
  &#xD;
            4. Subjects who have dementia&#xD;
  &#xD;
            5. Subjects who have mental health issues such as depression disorder, attention&#xD;
               deficit/hyperactivity disorder (ADHD), or other issues&#xD;
  &#xD;
            6. Subjects who use or take &quot;Foods for Specified Health Uses&quot;, &quot;Foods with Function&#xD;
               Claims&quot;, or other functional food/beverage, as part of their daily intake&#xD;
  &#xD;
            7. Subjects who take supplements or foods that may improve cognitive functions, such as&#xD;
               phosphatidylserine, docosahexaenoic acid (DHA), eicosapentaenoic acid (EPA), ginkgo&#xD;
               leaf extract, tocotrienol, astaxanthin, gamma-aminobutyric acid (GABA), and&#xD;
               plasmalogen, as part of their daily intake&#xD;
  &#xD;
            8. Subjects who take blue-backed fish such as sardines, mackerel, and saury for 4&#xD;
               days/week or over&#xD;
  &#xD;
            9. Subjects who use devices, equipment, and applications that may affect cognitive&#xD;
               functions (e.g., brain training puzzles, brain training games) as part of their daily&#xD;
               life&#xD;
  &#xD;
           10. Subjects regularly taking medications (including herbal medicines) and supplements&#xD;
  &#xD;
           11. Subjects who are allergic to medications and/or the test food related products&#xD;
  &#xD;
           12. Subjects who are pregnant, breast-feeding or planning for pregnancy during the trial&#xD;
               period&#xD;
  &#xD;
           13. Subjects who have been enrolled in other clinical trials 28 days before the agreement&#xD;
               to participate in this trial or those who plan to enroll in another clinical trial&#xD;
               during the trial period&#xD;
  &#xD;
           14. Subjects who are deemed ineligible to participate by the principal investigator&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>35 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Tsuyoshi Takara, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Medical Corporation Seishinkai, Takara Clinic</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Naoko Suzuki</last_name>
      <phone>+81-3-3818-0610</phone>
      <email>group_gakujutsu@orthomedico.jp</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Asami Baba, PhD</last_name>
      <phone>+81-3-3818-0610</phone>
      <email>asami-baba@orthomedico.jp</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Nerima Medical Association Minami-machi Clinic</name>
        <address>
          <city>Nerima-ku</city>
          <state>Tokyo</state>
          <zip>176-0002</zip>
          <country>Japan</country>
        </address>
      </facility>
      <contact>
        <last_name>Naoko Suzuki</last_name>
        <phone>+81-3-3818-0610</phone>
        <email>group_gakujutsu@orthomedico.jp</email>
      </contact>
      <contact_backup>
        <last_name>Asami Baba, PhD</last_name>
        <phone>+81-3-3818-0610</phone>
        <email>asami-baba@orthomedico.jp</email>
      </contact_backup>
      <investigator>
        <last_name>Masafumi Nagata, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Medical Corporation Seishinkai, Takara Clinic</name>
        <address>
          <city>Shinagawa-ku</city>
          <state>Tokyo</state>
          <zip>141-0022</zip>
          <country>Japan</country>
        </address>
      </facility>
      <contact>
        <last_name>Naoko Suzuki</last_name>
        <phone>+81-3-3818-0610</phone>
        <email>group_gakujutsu@orthomedico.jp</email>
      </contact>
      <contact_backup>
        <last_name>Asami Baba, PhD</last_name>
        <phone>+81-3-3818-0610</phone>
        <email>asami-baba@orthomedico.jp</email>
      </contact_backup>
      <investigator>
        <last_name>Tsuyoshi Takara, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Japan</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 4, 2023</study_first_submitted>
    <study_first_submitted_qc>July 18, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>July 18, 2023</last_update_submitted>
    <last_update_submitted_qc>July 18, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 27, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Phosphatidylserine</keyword>
    <keyword>Cognitive function</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>Data sharing will be discussed among the research affiliates after the study is completed.</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05962008
  org study id: 06788-0019-10
  nct id: NCT05962008
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The main objective of this trial is to verify the effects of consumption of
        phosphatidylserine for 12 weeks on the cognitive function in healthy Japanese subjects.
  In this study, the investigators will evaluate the cognitive function before and after the
        intervention. The groups to be compared are omega-3-phosphatidylserine derived from herring
        roe, phosphatidylserine derived from soybean, and a placebo.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: The measured value of the standardized score of composite memory at Week 12
  time frame: Week 12
  description: Verbal Memory (VBM) test and Visual Memory (VIM) test are measured using Cognitrax® which is powered by CNS Vital Signs®, a neurocognitive test system. The standardized score of composite memory is calculated from results of these two tests. This score has been normalized with a mean of 100 and a standard deviation of 15 based on age-matched reference data. Higher scores are always better.
  measure: The amount of change of the standardized score of composite memory between Base line and Week 12
  time frame: Base line and Week 12
  description: VBM test and VIM test are measured using Cognitrax® which is powered by CNS Vital Signs®, a neurocognitive test system. The standardized score of composite memory is calculated from results of these two tests. This score has been normalized with a mean of 100 and a standard deviation of 15 based on age-matched reference data. Higher scores are always better.
  measure: The measured value of the standardized score of neurocognition index (NCI) at Week 12
  time frame: Week 12
  description: Seven neurocognitive tests {VBM, VIM, Finger Tapping (FTT), Symbol Digit Coding (SDC), Stroop Test (ST), Shifting Attention (SAT), and Continuous Performance (CPT)} are measured using Cognitrax® which is powered by CNS Vital Signs®, a neurocognitive test system. The standardized score of NCI is calculated from results of these seven tests. This score has been normalized with a mean of 100 and a standard deviation of 15 based on age-matched reference data. Higher scores are always better.
  measure: The amount of change of the standardized score of NCI between Base line and Week 12
  time frame: Base line and Week 12
  description: Seven neurocognitive tests {VBM, VIM, FTT, SDC, ST, SAT, and CPT} are measured using Cognitrax® which is powered by CNS Vital Signs®, a neurocognitive test system. The standardized score of NCI is calculated from results of these seven tests. This score has been normalized with a mean of 100 and a standard deviation of 15 based on age-matched reference data. Higher scores are always better.
  measure: The measured value of the standardized score of verbal memory at Week 12
  time frame: Week 12
  description: VBM test is measured using Cognitrax® which is powered by CNS Vital Signs®, a neurocognitive test system. The standardized score of verbal memory is calculated from the result of this test. This score has been normalized with a mean of 100 and a standard deviation of 15 based on age-matched reference data. Higher scores are always better.
  measure: The amount of change of the standardized score of verbal memory between Base line and Week 12
  time frame: Base line and Week 12
  description: VBM test is measured using Cognitrax® which is powered by CNS Vital Signs®, a neurocognitive test system. The standardized score of verbal memory is calculated from the result of this test. This score has been normalized with a mean of 100 and a standard deviation of 15 based on age-matched reference data. Higher scores are always better.
  measure: The measured value of the standardized score of visual memory at Week 12
  time frame: Week 12
  description: VIM test is measured using Cognitrax® which is powered by CNS Vital Signs®, a neurocognitive test system. The standardized score of visual memory is calculated from the result of this test. This score has been normalized with a mean of 100 and a standard deviation of 15 based on age-matched reference data. Higher scores are always better.
  measure: The amount of change of the standardized score of visual memory between Base line and Week 12
  time frame: Base line and Week 12
  description: VIM test is measured using Cognitrax® which is powered by CNS Vital Signs®, a neurocognitive test system. The standardized score of visual memory is calculated from the result of this test. This score has been normalized with a mean of 100 and a standard deviation of 15 based on age-matched reference data. Higher scores are always better.
  measure: The measured value of the standardized score of psychomotor speed at Week 12
  time frame: Week 12
  description: FTT test and SDC test are measured using Cognitrax® which is powered by CNS Vital Signs®, a neurocognitive test system. The standardized score of psychomotor speed is calculated from results of these two tests. This score has been normalized with a mean of 100 and a standard deviation of 15 based on age-matched reference data. Higher scores are always better.
  measure: The amount of change of the standardized score of psychomotor speed between Base line and Week 12
  time frame: Base line and Week 12
  description: FTT test and SDC test are measured using Cognitrax® which is powered by CNS Vital Signs®, a neurocognitive test system. The standardized score of psychomotor speed is calculated from results of these two tests. This score has been normalized with a mean of 100 and a standard deviation of 15 based on age-matched reference data. Higher scores are always better.
  measure: The measured value of the standardized score of reaction time at Week 12
  time frame: Week 12
  description: ST test is measured using Cognitrax® which is powered by CNS Vital Signs®, a neurocognitive test system. The standardized score of reaction time is calculated from the result of this test. This score has been normalized with a mean of 100 and a standard deviation of 15 based on age-matched reference data. Higher scores are always better.
  measure: The amount of change of the standardized score of reaction time between Base line and Week 12
  time frame: Base line and Week 12
  description: ST test is measured using Cognitrax® which is powered by CNS Vital Signs®, a neurocognitive test system. The standardized score of reaction time is calculated from the result of this test. This score has been normalized with a mean of 100 and a standard deviation of 15 based on age-matched reference data. Higher scores are always better.
  measure: The measured value of the standardized score of complex attention at Week 12
  time frame: Week 12
  description: ST test, SAT test, and CPT test are measured using Cognitrax® which is powered by CNS Vital Signs®, a neurocognitive test system. The standardized score of complex attention is calculated from results of these three tests. This score has been normalized with a mean of 100 and a standard deviation of 15 based on age-matched reference data. Higher scores are always better.
  measure: The amount of change of the standardized score of complex attention between Base line and Week 12
  time frame: Base line and Week 12
  description: ST test, SAT test, and CPT test are measured using Cognitrax® which is powered by CNS Vital Signs®, a neurocognitive test system. The standardized score of complex attention is calculated from results of these three tests. This score has been normalized with a mean of 100 and a standard deviation of 15 based on age-matched reference data. Higher scores are always better.
  measure: The measured value of the standardized score of cognitive flexibility at Week 12
  time frame: Week 12
  description: ST test and SAT test are measured using Cognitrax® which is powered by CNS Vital Signs®, a neurocognitive test system. The standardized score of cognitive flexibility is calculated from results of these two tests. This score has been normalized with a mean of 100 and a standard deviation of 15 based on age-matched reference data. Higher scores are always better.
  measure: The amount of change of the standardized score of cognitive flexibility between Base line and Week 12
  time frame: Base line and Week 12
  description: ST test and SAT test are measured using Cognitrax® which is powered by CNS Vital Signs®, a neurocognitive test system. The standardized score of cognitive flexibility is calculated from results of these two tests. This score has been normalized with a mean of 100 and a standard deviation of 15 based on age-matched reference data. Higher scores are always better.
  measure: The measured value of the standardized score of processing speed at Week 12
  time frame: Week 12
  description: SDC test is measured using Cognitrax® which is powered by CNS Vital Signs®, a neurocognitive test system. The standardized score of processing speed is calculated from the result of this test. This score has been normalized with a mean of 100 and a standard deviation of 15 based on age-matched reference data. Higher scores are always better.
  measure: The amount of change of the standardized score of processing speed between Base line and Week 12
  time frame: Base line and Week 12
  description: SDC test is measured using Cognitrax® which is powered by CNS Vital Signs®, a neurocognitive test system. The standardized score of processing speed is calculated from the result of this test. This score has been normalized with a mean of 100 and a standard deviation of 15 based on age-matched reference data. Higher scores are always better.
  measure: The measured value of the standardized score of executive function at Week 12
  time frame: Week 12
  description: SAT test is measured using Cognitrax® which is powered by CNS Vital Signs®, a neurocognitive test system. The standardized score of executive function is calculated from the result of this test. This score has been normalized with a mean of 100 and a standard deviation of 15 based on age-matched reference data. Higher scores are always better.
  measure: The amount of change of the standardized score of executive function between Base line and Week 12
  time frame: Base line and Week 12
  description: SAT test is measured using Cognitrax® which is powered by CNS Vital Signs®, a neurocognitive test system. The standardized score of executive function is calculated from the result of this test. This score has been normalized with a mean of 100 and a standard deviation of 15 based on age-matched reference data. Higher scores are always better.
  measure: The measured value of the standardized score of social acuity at Week 12
  time frame: Week 12
  description: Perception of Emotions (POET) test is measured using Cognitrax® which is powered by CNS Vital Signs®, a neurocognitive test system. The standardized score of social acuity is calculated from the result of this test. This score has been normalized with a mean of 100 and a standard deviation of 15 based on age-matched reference data. Higher scores are always better.
  measure: The amount of change of the standardized score of social acuity between Base line and Week 12
  time frame: Base line and Week 12
  description: POET test is measured using Cognitrax® which is powered by CNS Vital Signs®, a neurocognitive test system. The standardized score of social acuity is calculated from the result of this test. This score has been normalized with a mean of 100 and a standard deviation of 15 based on age-matched reference data. Higher scores are always better.
  measure: The measured value of the standardized score of reasoning at Week 12
  time frame: Week 12
  description: Non-Verbal Reasoning (NVRT) test is measured using Cognitrax® which is powered by CNS Vital Signs®, a neurocognitive test system. The standardized score of reasoning is calculated from the result of this test. This score has been normalized with a mean of 100 and a standard deviation of 15 based on age-matched reference data. Higher scores are always better.
  measure: The amount of change of the standardized score of reasoning between Base line and Week 12
  time frame: Base line and Week 12
  description: NVRT test is measured using Cognitrax® which is powered by CNS Vital Signs®, a neurocognitive test system. The standardized score of reasoning is calculated from the result of this test. This score has been normalized with a mean of 100 and a standard deviation of 15 based on age-matched reference data. Higher scores are always better.
  measure: The measured value of the standardized score of working memory at Week 12
  time frame: Week 12
  description: 4-Part Continuous Performance (FPCPT) test is measured using Cognitrax® which is powered by CNS Vital Signs®, a neurocognitive test system. The standardized score of working memory is calculated from the result of this test. This score has been normalized with a mean of 100 and a standard deviation of 15 based on age-matched reference data. Higher scores are always better.
  measure: The amount of change of the standardized score of working memory between Base line and Week 12
  time frame: Base line and Week 12
  description: FPCPT test is measured using Cognitrax® which is powered by CNS Vital Signs®, a neurocognitive test system. The standardized score of working memory is calculated from the result of this test. This score has been normalized with a mean of 100 and a standard deviation of 15 based on age-matched reference data. Higher scores are always better.
  measure: The measured value of the standardized score of sustained attention at Week 12
  time frame: Week 12
  description: FPCPT test is measured using Cognitrax® which is powered by CNS Vital Signs®, a neurocognitive test system. The standardized score of sustained attention is calculated from the result of this test. This score has been normalized with a mean of 100 and a standard deviation of 15 based on age-matched reference data. Higher scores are always better.
  measure: The amount of change of the standardized score of sustained attention between Base line and Week 12
  time frame: Base line and Week 12
  description: FPCPT test is measured using Cognitrax® which is powered by CNS Vital Signs®, a neurocognitive test system. The standardized score of sustained attention is calculated from the result of this test. This score has been normalized with a mean of 100 and a standard deviation of 15 based on age-matched reference data. Higher scores are always better.
  measure: The measured value of the standardized score of simple attention at Week 12
  time frame: Week 12
  description: CPT test is measured using Cognitrax® which is powered by CNS Vital Signs®, a neurocognitive test system. The standardized score of simple attention is calculated from the result of this test. This score has been normalized with a mean of 100 and a standard deviation of 15 based on age-matched reference data. Higher scores are always better.
  measure: The amount of change of the standardized score of simple attention between Base line and Week 12
  time frame: Base line and Week 12
  description: CPT test is measured using Cognitrax® which is powered by CNS Vital Signs®, a neurocognitive test system. The standardized score of simple attention is calculated from the result of this test. This score has been normalized with a mean of 100 and a standard deviation of 15 based on age-matched reference data. Higher scores are always better.
  measure: The measured value of the standardized score of motor speed at Week 12
  time frame: Week 12
  description: FTT test is measured using Cognitrax® which is powered by CNS Vital Signs®, a neurocognitive test system. The standardized score of motor speed is calculated from the result of this test. This score has been normalized with a mean of 100 and a standard deviation of 15 based on age-matched reference data. Higher scores are always better.
  measure: The amount of change of the standardized score of motor speed between Base line and Week 12
  time frame: Base line and Week 12
  description: FTT test is measured using Cognitrax® which is powered by CNS Vital Signs®, a neurocognitive test system. The standardized score of motor speed is calculated from the result of this test. This score has been normalized with a mean of 100 and a standard deviation of 15 based on age-matched reference data. Higher scores are always better.
  arm group label: Omega-3-phosphatidylserine derived from herring roe
  arm group type: Active Comparator
  description: Take 300 mg/day of omega-3-phosphatidylserine derived from herring roe.
  arm group label: Phosphatidylserine derived from soybean
  arm group type: Active Comparator
  description: Take 300 mg/day of phosphatidylserine derived from soybean.
  arm group label: Placebo
  arm group type: Placebo Comparator
  description: Take 0 mg/day of phosphatidylserine.
  intervention type: Dietary Supplement
  intervention name: DHAPS® product
  description: Take 4 capsules per day after breakfast with warm water.
  arm group label: Omega-3-phosphatidylserine derived from herring roe
  intervention type: Dietary Supplement
  intervention name: BioPS® product
  description: Take 4 capsules per day after breakfast with warm water.
  arm group label: Phosphatidylserine derived from soybean
  intervention type: Dietary Supplement
  intervention name: Placebo
  description: Take 4 capsules per day after breakfast with warm water.
  arm group label: Placebo
  criteria: 
  gender: All
  minimum age: 35 Years
  maximum age: 65 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Tsuyoshi Takara, MD
  role: Principal Investigator
  affiliation: Medical Corporation Seishinkai, Takara Clinic
  last name: Naoko Suzuki
  phone: +81-3-3818-0610
  email: group_gakujutsu@orthomedico.jp
  last name: Asami Baba, PhD
  phone: +81-3-3818-0610
  email: asami-baba@orthomedico.jp
  facility: 
  contact: 
  contact backup: 
  investigator: 
  facility: 
  contact: 
  contact backup: 
  investigator: 
  country: Japan
  responsible party type: Sponsor
  sharing ipd: No
  ipd description: Data sharing will be discussed among the research affiliates after the study is completed.