Effects of Consumption of Phosphatidylserine on the Cognitive Function

Orthomedico

Status: Completed

Conditions: Healthy Japanese Subjects

Treatments: Dietary Supplement: Placebo; Dietary Supplement: BioPS® product; Dietary Supplement: DHAPS® product

Study type: Interventional

Funder types: Other

Identifiers

NCT05962008

06788-0019-10

Details and patient eligibility

About

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.

Full 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.

Enrollment: 114 patients

Sex: All

Ages: 35 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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114 participants in 3 patient groups, including a placebo group

Omega-3-phosphatidylserine derived from herring roe

Active Comparator group

Description:

Take 300 mg/day of omega-3-phosphatidylserine derived from herring roe.

Treatment:

Dietary Supplement: DHAPS® product

Phosphatidylserine derived from soybean

Active Comparator group

Description:

Take 300 mg/day of phosphatidylserine derived from soybean.

Treatment:

Dietary Supplement: BioPS® product

Placebo

Placebo Comparator group

Description:

Take 0 mg/day of phosphatidylserine.

Treatment:

Dietary Supplement: Placebo