Clinical trial NCT05962008: Effects of Consumption of Phosphatidylserine on the Cognitive Function
Official title: Effects of Consumption of Phosphatidylserine on the Cognitive Function: a Randomized, Placebo-controlled, Double-blind, Parallel-group Comparison Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Japanese Subjects
Keywords: Phosphatidylserine
Cognitive function
Lead sponsor: Orthomedico Inc.
Sponsor class: OTHER
Collaborators: name: ECA Healthcare Inc.
First posted: 2023-07-27
Enrollment: 114
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: The measured value of the standardized score of composite memory at Week 12
timeFrame: Week 12
Secondary outcomes:
measure: The amount of change of the standardized score of composite memory between Base line and Week 12
timeFrame: Base line and Week 12
measure: The measured value of the standardized score of neurocognition index (NCI) at Week 12
timeFrame: Week 12
measure: The amount of change of the standardized score of NCI between Base line and Week 12
timeFrame: Base line and Week 12
measure: The measured value of the standardized score of verbal memory at Week 12
timeFrame: Week 12
measure: The amount of change of the standardized score of verbal memory between Base line and Week 12
timeFrame: Base line and Week 12
measure: The measured value of the standardized score of visual memory at Week 12
timeFrame: Week 12
measure: The amount of change of the standardized score of visual memory between Base line and Week 12
timeFrame: Base line and Week 12
measure: The measured value of the standardized score of psychomotor speed at Week 12
timeFrame: Week 12
measure: The amount of change of the standardized score of psychomotor speed between Base line and Week 12
timeFrame: Base line and Week 12
measure: The measured value of the standardized score of reaction time at Week 12
timeFrame: Week 12
measure: The amount of change of the standardized score of reaction time between Base line and Week 12
timeFrame: Base line and Week 12
measure: The measured value of the standardized score of complex attention at Week 12
timeFrame: Week 12
measure: The amount of change of the standardized score of complex attention between Base line and Week 12
timeFrame: Base line and Week 12
measure: The measured value of the standardized score of cognitive flexibility at Week 12
timeFrame: Week 12
measure: The amount of change of the standardized score of cognitive flexibility between Base line and Week 12
timeFrame: Base line and Week 12
measure: The measured value of the standardized score of processing speed at Week 12
timeFrame: Week 12
measure: The amount of change of the standardized score of processing speed between Base line and Week 12
timeFrame: Base line and Week 12
measure: The measured value of the standardized score of executive function at Week 12
timeFrame: Week 12
measure: The amount of change of the standardized score of executive function between Base line and Week 12
timeFrame: Base line and Week 12
measure: The measured value of the standardized score of social acuity at Week 12
timeFrame: Week 12
measure: The amount of change of the standardized score of social acuity between Base line and Week 12
timeFrame: Base line and Week 12
measure: The measured value of the standardized score of reasoning at Week 12
timeFrame: Week 12
measure: The amount of change of the standardized score of reasoning between Base line and Week 12
timeFrame: Base line and Week 12
measure: The measured value of the standardized score of working memory at Week 12
timeFrame: Week 12
measure: The amount of change of the standardized score of working memory between Base line and Week 12
timeFrame: Base line and Week 12
measure: The measured value of the standardized score of sustained attention at Week 12
timeFrame: Week 12
measure: The amount of change of the standardized score of sustained attention between Base line and Week 12
timeFrame: Base line and Week 12
measure: The measured value of the standardized score of simple attention at Week 12
timeFrame: Week 12
measure: The amount of change of the standardized score of simple attention between Base line and Week 12
timeFrame: Base line and Week 12
measure: The measured value of the standardized score of motor speed at Week 12
timeFrame: Week 12
measure: The amount of change of the standardized score of motor speed between Base line and Week 12
timeFrame: Base line and Week 12
Other outcomes:
Locations:
city: Nerima-ku
country: Japan
facility: Nerima Medical Association Minami-machi Clinic
state: Tokyo
city: Shinagawa-ku
country: Japan
facility: Medical Corporation Seishinkai, Takara Clinic
state: Tokyo
Study officials:
affiliation: Medical Corporation Seishinkai, Takara Clinic
name: Tsuyoshi Takara, MD
role: PRINCIPAL_INVESTIGATOR
References: