Effects of Consumption of Phosphatidylserine on the Cognitive Function

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Healthy Japanese Subjects

Intervention / Treatment
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* Dietary Supplement: DHAPS® product
* Dietary Supplement: BioPS® product
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Omega-3-phosphatidylserine derived from herring roe<br>Take 300 mg/day of omega-3-phosphatidylserine derived from herring roe. | Dietary Supplement: DHAPS® product<br>* Take 4 capsules per day after breakfast with warm water.<br>|
| Active Comparator: Phosphatidylserine derived from soybean<br>Take 300 mg/day of phosphatidylserine derived from soybean. | Dietary Supplement: BioPS® product<br>* Take 4 capsules per day after breakfast with warm water.<br>|
| Placebo Comparator: Placebo<br>Take 0 mg/day of phosphatidylserine. | Dietary Supplement: Placebo<br>* Take 4 capsules per day after breakfast with warm water.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The measured value of the standardized score of composite memory at 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. | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The amount of change of the standardized score of composite memory between 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. | Base line and Week 12 | 
| The measured value of the standardized score of neurocognition index (NCI) at 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. | Week 12 | 
| The amount of change of the standardized score of NCI between 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. | Base line and Week 12 | 
| The measured value of the standardized score of verbal memory at 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. | Week 12 | 
| The amount of change of the standardized score of verbal memory between 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. | Base line and Week 12 | 
| The measured value of the standardized score of visual memory at 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. | Week 12 | 
| The amount of change of the standardized score of visual memory between 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. | Base line and Week 12 | 
| The measured value of the standardized score of psychomotor speed at 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. | Week 12 | 
| The amount of change of the standardized score of psychomotor speed between 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. | Base line and Week 12 | 
| The measured value of the standardized score of reaction time at 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. | Week 12 | 
| The amount of change of the standardized score of reaction time between 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. | Base line and Week 12 | 
| The measured value of the standardized score of complex attention at 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. | Week 12 | 
| The amount of change of the standardized score of complex attention between 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. | Base line and Week 12 | 
| The measured value of the standardized score of cognitive flexibility at 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. | Week 12 | 
| The amount of change of the standardized score of cognitive flexibility between 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. | Base line and Week 12 | 
| The measured value of the standardized score of processing speed at 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. | Week 12 | 
| The amount of change of the standardized score of processing speed between 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. | Base line and Week 12 | 
| The measured value of the standardized score of executive function at 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. | Week 12 | 
| The amount of change of the standardized score of executive function between 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. | Base line and Week 12 | 
| The measured value of the standardized score of social acuity at 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. | Week 12 | 
| The amount of change of the standardized score of social acuity between 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. | Base line and Week 12 | 
| The measured value of the standardized score of reasoning at 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. | Week 12 | 
| The amount of change of the standardized score of reasoning between 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. | Base line and Week 12 | 
| The measured value of the standardized score of working memory at 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. | Week 12 | 
| The amount of change of the standardized score of working memory between 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. | Base line and Week 12 | 
| The measured value of the standardized score of sustained attention at 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. | Week 12 | 
| The amount of change of the standardized score of sustained attention between 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. | Base line and Week 12 | 
| The measured value of the standardized score of simple attention at 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. | Week 12 | 
| The amount of change of the standardized score of simple attention between 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. | Base line and Week 12 | 
| The measured value of the standardized score of motor speed at 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. | Week 12 | 
| The amount of change of the standardized score of motor speed between 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. | Base line and Week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Phosphatidylserine, Cognitive function