Effects of Consumption of Phosphatidylserine on the Cognitive Function

NCT ID: NCT05962008

Last Updated: 2024-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

114 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-20

Study Completion Date

2024-03-17

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy Japanese Subjects

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Omega-3-phosphatidylserine derived from herring roe

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

Group Type ACTIVE_COMPARATOR

DHAPS® product

Intervention Type DIETARY_SUPPLEMENT

Take 4 capsules per day after breakfast with warm water.

Phosphatidylserine derived from soybean

Take 300 mg/day of phosphatidylserine derived from soybean.

Group Type ACTIVE_COMPARATOR

BioPS® product

Intervention Type DIETARY_SUPPLEMENT

Take 4 capsules per day after breakfast with warm water.

Placebo

Take 0 mg/day of phosphatidylserine.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Take 4 capsules per day after breakfast with warm water.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

DHAPS® product

Take 4 capsules per day after breakfast with warm water.

Intervention Type DIETARY_SUPPLEMENT

BioPS® product

Take 4 capsules per day after breakfast with warm water.

Intervention Type DIETARY_SUPPLEMENT

Placebo

Take 4 capsules per day after breakfast with warm water.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
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
Minimum Eligible Age

35 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

ECA Healthcare Inc.

UNKNOWN

Sponsor Role collaborator

Orthomedico Inc.

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Tsuyoshi Takara, MD

Role: PRINCIPAL_INVESTIGATOR

Medical Corporation Seishinkai, Takara Clinic

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Nerima Medical Association Minami-machi Clinic

Nerima-ku, Tokyo, Japan

Site Status

Medical Corporation Seishinkai, Takara Clinic

Shinagawa-ku, Tokyo, Japan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Japan

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

06788-0019-10

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.