Effects of Consumption of Phosphatidylserine on the Cognitive Function
NCT ID: NCT05962008
Last Updated: 2024-08-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
114 participants
INTERVENTIONAL
2023-07-20
2024-03-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Omega-3-phosphatidylserine derived from herring roe
Take 300 mg/day of omega-3-phosphatidylserine derived from herring roe.
DHAPS® product
Take 4 capsules per day after breakfast with warm water.
Phosphatidylserine derived from soybean
Take 300 mg/day of phosphatidylserine derived from soybean.
BioPS® product
Take 4 capsules per day after breakfast with warm water.
Placebo
Take 0 mg/day of phosphatidylserine.
Placebo
Take 4 capsules per day after breakfast with warm water.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
8. Subjects who are judged as eligible to participate in the study by the physician
Exclusion Criteria
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
35 Years
65 Years
ALL
Yes
Sponsors
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ECA Healthcare Inc.
UNKNOWN
Orthomedico Inc.
OTHER
Responsible Party
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Principal Investigators
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Tsuyoshi Takara, MD
Role: PRINCIPAL_INVESTIGATOR
Medical Corporation Seishinkai, Takara Clinic
Locations
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Nerima Medical Association Minami-machi Clinic
Nerima-ku, Tokyo, Japan
Medical Corporation Seishinkai, Takara Clinic
Shinagawa-ku, Tokyo, Japan
Countries
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Other Identifiers
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06788-0019-10
Identifier Type: -
Identifier Source: org_study_id
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