Effects of Consumption of Phosphatidylserine on the Cognitive Function

NCT05962008 | Completed DMC

• 1 other identifier: 06788-0019-10
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Healthy Japanese Subjects

Keywords

Phosphatidylserine; Cognitive function

Outcome Measures

Primary Outcomes (1)

• 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 (31)

• The amount of change of the standardized score of composite memory between Base line and Week 12

  Base line and Week 12

• The measured value of the standardized score of neurocognition index (NCI) at Week 12

  Week 12

• The amount of change of the standardized score of NCI between Base line and Week 12

  Base line and Week 12

• The measured value of the standardized score of verbal memory at Week 12

  Week 12

• The amount of change of the standardized score of verbal memory between Base line and Week 12

  Base line and Week 12

Study Arms (3)

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

Interventions

DHAPS® product DIETARY_SUPPLEMENT

Take 4 capsules per day after breakfast with warm water.

Omega-3-phosphatidylserine derived from herring roe

BioPS® product DIETARY_SUPPLEMENT

Take 4 capsules per day after breakfast with warm water.

Phosphatidylserine derived from soybean

Placebo DIETARY_SUPPLEMENT

Take 4 capsules per day after breakfast with warm water.

Placebo

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 are judged as eligible to participate in the study by the physician

You may not qualify if:

• 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

Sponsors & Collaborators

• Orthomedico Inc.: lead
• ECA Healthcare Inc.: collaborator

Study Sites (2)

Nerima Medical Association Minami-machi Clinic

Nerima-ku, Tokyo, 176-0002, Japan

Location

Medical Corporation Seishinkai, Takara Clinic

Shinagawa-ku, Tokyo, 141-0022, Japan

Location

Study Officials

• Tsuyoshi Takara, MD

  Medical Corporation Seishinkai, Takara Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2023
• First Posted: July 27, 2023
• Study Start: July 20, 2023
• Primary Completion: March 17, 2024
• Study Completion: March 17, 2024
• Last Updated: August 2, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

JP (2)