Effects of Consumption of Phosphatidylserine on the Cogni... | NCT05962008

NCT05962008

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Name	Class
ECA Healthcare Inc.	UNKNOWN

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Omega-3-phosphatidylserine derived from herring roe	Active Comparator	Take 300 mg/day of omega-3-phosphatidylserine derived from herring roe.	Dietary Supplement: DHAPS® product
Phosphatidylserine derived from soybean	Active Comparator	Take 300 mg/day of phosphatidylserine derived from soybean.	Dietary Supplement: BioPS® product
Placebo	Placebo Comparator	Take 0 mg/day of phosphatidylserine.	Dietary Supplement: Placebo

Name	Type	Description	Arm Group Labels	Other Names
DHAPS® product	Dietary Supplement	Take 4 capsules per day after breakfast with warm water.	Omega-3-phosphatidylserine derived from herring roe

Outcomes Module

Primary Outcomes

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 Outcomes

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.

Eligibility Module

Eligibility Criteria

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

Facility	Status	City	State	ZIP	Country	Contacts
Nerima Medical Association Minami-machi Clinic		Nerima-ku	Tokyo	176-0002	Japan
Medical Corporation Seishinkai, Takara Clinic