Healthy Japanese
Conditions
Sponsors
OSAKA SODA CO., LTD.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Japanese 2. Men or women 3. Individuals aged 40 or more 4. Healthy individuals 5. Individuals whose Mini-Mental State Examination (MMSE) score is 24 or higher at screening 6. Individuals whose validity indicator for the Visual Memory test of Cognitrax is "yes" at screening 7. Individuals whose standardized score for Visual Memory in Cognitrax is 99 or lower at screening
Exclusion criteria
Exclusion criteria: 1. Individuals who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, or myocardial infarction 2. Individuals who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Individuals who are currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. Individuals who are taking "Foods for Specified Health Uses" or "Foods with Functional Claims" 5. Individuals who are taking or using medications (including herbal medicines) or supplements 6. Individuals who are allergic to medicines or foods related to the test product 7. Individuals who are pregnant, lactating, or planning to become pregnant during this study 8. Individuals who have been enrolled in other clinical studies within the last 28 days before the agreement to participate in this study or plan to participate in another study during this study 9. Individuals who usually take supplements or foods that may be related to improving cognitive functions, such as docosahexaenoic acid (DHA), eicosapentaenoic acid (EPA), ginkgo leaf extract, tocotrienol, astaxanthin, gamma-aminobutyric acid (GABA), phosphatidylserine, and plasmalogen 10. Individuals who use devices, equipment, and applications that may affect cognitive functions (such as brain training puzzles or games) in daily 11. Individuals who are judged as ineligible to participate in this study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The measured value of the standardized score of Visual Memory at 12 weeks after intervention (12w) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The change and percentage change in the standardized score of Visual Memory from screening at 12w 2. The measured values of the standardized scores of Neurocognition Index (NCI), Composite Memory, Verbal Memory, Psychomotor Speed, Reaction Time, Complex Attention, Cognitive Flexibility, Processing Speed, Executive Function, Social Acuity, Reasoning, Working Memory, Sustained Attention, Simple Attention, and Motor Speed at 12w, and their changes and percentage changes from screening | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed