Effects of Consumption of Phosphatidylserine on the Cognitive Function

Healthy Japanese Subjects Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05962008
• Other study ID #: 06788-0019-10
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 20, 2023
• Est. completion date: March 11, 2024

Study information

• Verified date: July 2023
• Source: Orthomedico Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 114
• Est. completion date: March 11, 2024
• Est. primary completion date: March 11, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Japanese

2. Male and female

3. Subjects aged 35-65

4. Healthy subjects

5. Subjects who notice a decline in memory

6. Subjects whose scoring of Mini Mental State Examination (MMSE) is 24 or more

7. 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")

8. Subjects who are judged as eligible to participate in the study by the physician

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

Related Conditions & MeSH terms

• Healthy Japanese Subjects

Intervention

Dietary Supplement:
• DHAPS® product
Take 4 capsules per day after breakfast with warm water.
• BioPS® product
Take 4 capsules per day after breakfast with warm water.
• Placebo
Take 4 capsules per day after breakfast with warm water.

Locations

Country	Name	City	State
Japan	Nerima Medical Association Minami-machi Clinic	Nerima-ku	Tokyo
Japan	Medical Corporation Seishinkai, Takara Clinic	Shinagawa-ku	Tokyo

Sponsors (2)

Lead Sponsor	Collaborator
Orthomedico Inc.	ECA Healthcare Inc.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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