Effects of consumption of phosphatidylserine on the cognitive function: a randomized, placebo-controlled, double-blind, parallel-group comparison study

Recruitment & Eligibility

Status: Complete: follow-up continuing

Sex: All

Target Recruitment: 114

Inclusion Criteria

Not provided

Exclusion Criteria

1. Subjects undergoing medical treatment or having a medical history of malignant tumor, heart failure, or myocardial infarction 2. Subjects carrying a pacemaker or an implantable cardioverter defibrillator (ICD) 3. 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 4. Subjects who have dementia 5. Subjects who have mental health issues such as depression disorder, attention deficit/hyperactivity disorder (ADHD), or other issues 6. 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 7. 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 8. Subjects who take blue-backed fish such as sardines, mackerel, and saury for 4 days/week or over 9. 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 10. Subjects regularly taking medications (including herbal medicines) and supplements 11. Subjects who are allergic to medications and/or the test food related products 12. Subjects who are pregnant, breast-feeding or planning for pregnancy during the trial period 13. 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 14. Subjects who are deemed ineligible to participate by the principal investigator

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. The measured value of the standardized score of composite memory at 12 weeks after consumption (12w)

Secondary Outcome Measures

Name	Time	Method
1. The amount of change of the standardized score of composite memory between screening (before consumption; Scr) and 12w 2. The measured value of the standardized scores of each cognitive domain {neurocognition index (NCI), verbal memory, visual memory, psychomotor speed, reaction time, complex attention, cognitive flexibility, processing speed, executive function, social acuity, reasoning, working memory, sustained attention, simple attention and motor speed} at 12w and the amount of change of each item from Scr to 12w

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