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Completed

NCT Number: NCT05962008

Effects of Consumption of Phosphatidylserine on the Cognitive Function

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.

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Key information

Conditions

Healthy Japanese Subjects

Age range

35 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nerima Medical Association Minami-machi Clinic, Nerima-ku, Tokyo, Japan

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Japanese
  • Male and female
  • Subjects aged 35-65
  • Healthy subjects
  • Subjects who notice a decline in memory
  • Subjects whose scoring of Mini Mental State Examination (MMSE) is 24 or more
  • Subjects who met the inclusion criteria 1. ~ 6. and have relatively low standardized score in composite memory measured using Cognitrax at Scr (Selection of those with relatively low standardized scores will be conducted in blocks of "Subjects aged 50 or over" and "Subjects aged under 50")
  • Subjects who are judged as eligible to participate in the study by the physician

Exclusion criteria

  • Subjects undergoing medical treatment or having a medical history of malignant tumor, heart failure, or myocardial infarction
  • Subjects carrying a pacemaker or an implantable cardioverter defibrillator (ICD)
  • Subjects undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disease, kidney disease, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases
  • Subjects who have dementia
  • Subjects who have mental health issues such as depression disorder, attention deficit/hyperactivity disorder (ADHD), or other issues
  • Subjects who use or take "Foods for Specified Health Uses", "Foods with Function Claims", or other functional food/beverage, as part of their daily intake
  • Subjects who take supplements or foods that may improve cognitive functions, such as phosphatidylserine, docosahexaenoic acid (DHA), eicosapentaenoic acid (EPA), ginkgo leaf extract, tocotrienol, astaxanthin, gamma-aminobutyric acid (GABA), and plasmalogen, as part of their daily intake
  • Subjects who take blue-backed fish such as sardines, mackerel, and saury for 4 days/week or over
  • Subjects who use devices, equipment, and applications that may affect cognitive functions (e.g., brain training puzzles, brain training games) as part of their daily life
  • Subjects regularly taking medications (including herbal medicines) and supplements
  • Subjects who are allergic to medications and/or the test food related products
  • Subjects who are pregnant, breast-feeding or planning for pregnancy during the trial period
  • Subjects who have been enrolled in other clinical trials 28 days before the agreement to participate in this trial or those who plan to enroll in another clinical trial during the trial period
  • Subjects who are deemed ineligible to participate by the principal investigator

Treatment and study plan

DHAPS® product

Dietary Supplement

Take 4 capsules per day after breakfast with warm water.

BioPS® product

Dietary Supplement

Take 4 capsules per day after breakfast with warm water.

Placebo

Dietary Supplement

Take 4 capsules per day after breakfast with warm water.

Primary outcomes

  1. The measured value of the standardized score of composite memory at Week 12

    Time frame: Week 12

    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.

Secondary outcomes

  1. The amount of change of the standardized score of composite memory between Base line and Week 12

    Time frame: Base line and Week 12

    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.

  2. The measured value of the standardized score of neurocognition index (NCI) at Week 12

    Time frame: Week 12

    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.

  3. The amount of change of the standardized score of NCI between Base line and Week 12

    Time frame: Base line and Week 12

    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.

  4. The measured value of the standardized score of verbal memory at Week 12

    Time frame: Week 12

    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.

  5. The amount of change of the standardized score of verbal memory between Base line and Week 12

    Time frame: Base line and Week 12

    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.

  6. The measured value of the standardized score of visual memory at Week 12

    Time frame: Week 12

    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.

  7. The amount of change of the standardized score of visual memory between Base line and Week 12

    Time frame: Base line and Week 12

    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.

  8. The measured value of the standardized score of psychomotor speed at Week 12

    Time frame: Week 12

    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.

  9. The amount of change of the standardized score of psychomotor speed between Base line and Week 12

    Time frame: Base line and Week 12

    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.

  10. The measured value of the standardized score of reaction time at Week 12

    Time frame: Week 12

    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.

  11. The amount of change of the standardized score of reaction time between Base line and Week 12

    Time frame: Base line and Week 12

    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.

  12. The measured value of the standardized score of complex attention at Week 12

    Time frame: Week 12

    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.

  13. The amount of change of the standardized score of complex attention between Base line and Week 12

    Time frame: Base line and Week 12

    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.

  14. The measured value of the standardized score of cognitive flexibility at Week 12

    Time frame: Week 12

    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.

  15. The amount of change of the standardized score of cognitive flexibility between Base line and Week 12

    Time frame: Base line and Week 12

    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.

  16. The measured value of the standardized score of processing speed at Week 12

    Time frame: Week 12

    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.

  17. The amount of change of the standardized score of processing speed between Base line and Week 12

    Time frame: Base line and Week 12

    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.

  18. The measured value of the standardized score of executive function at Week 12

    Time frame: Week 12

    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.

  19. The amount of change of the standardized score of executive function between Base line and Week 12

    Time frame: Base line and Week 12

    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.

  20. The measured value of the standardized score of social acuity at Week 12

    Time frame: Week 12

    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.

  21. The amount of change of the standardized score of social acuity between Base line and Week 12

    Time frame: Base line and Week 12

    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.

  22. The measured value of the standardized score of reasoning at Week 12

    Time frame: Week 12

    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.

  23. The amount of change of the standardized score of reasoning between Base line and Week 12

    Time frame: Base line and Week 12

    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.

  24. The measured value of the standardized score of working memory at Week 12

    Time frame: Week 12

    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.

  25. The amount of change of the standardized score of working memory between Base line and Week 12

    Time frame: Base line and Week 12

    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.

  26. The measured value of the standardized score of sustained attention at Week 12

    Time frame: Week 12

    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.

  27. The amount of change of the standardized score of sustained attention between Base line and Week 12

    Time frame: Base line and Week 12

    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.

  28. The measured value of the standardized score of simple attention at Week 12

    Time frame: Week 12

    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.

  29. The amount of change of the standardized score of simple attention between Base line and Week 12

    Time frame: Base line and Week 12

    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.

  30. The measured value of the standardized score of motor speed at Week 12

    Time frame: Week 12

    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.

  31. The amount of change of the standardized score of motor speed between Base line and Week 12

    Time frame: Base line and Week 12

    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.

Sponsors and collaborators

Lead sponsor

Orthomedico Inc.

Other

Collaborators

  • ECA Healthcare Inc.

Registry information

Official study title

Effects of Consumption of Phosphatidylserine on the Cognitive Function: a Randomized, Placebo-controlled, Double-blind, Parallel-group Comparison Study

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 27, 2023
Registry last updated
Aug 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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