Healthy Japanese
Conditions
Interventions
Duration: 12 weeks Test product: Test food Administration: Three capsules/pack/day
Duration: 12 weeks Test product: Placebo food Administration: Three capsules/pack/day
Sponsors
Euglena Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Japanese 2. Men or women 3. Participants aged 40 years or older 4. Healthy participants 5. Participants whose Mini-Mental State Examination (MMSE) score is 24 or higher at screening 6. Participants who have a "yes" in the validity indicator of Cognitrax on both verbal memory and visual memory at screening 7. Participants who meet inclusion criteria 1-6 and have a low standardized score for Verbal Memory on Cognitrax at screening
Exclusion criteria
Exclusion criteria: Participants who 1. are undergoing treatment or have a history of malignant tumor, heart failure, or myocardial infarction 2. have a pacemaker or an implantable cardioverter defibrillator 3. are 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. are taking Foods for Specified Health Uses or Foods with Functional Claims 5. are taking or using medicines (including herbal medicines) or supplements 6. are allergic to medicines or foods related to the test product 7. have dementia 8. have mental health issues such as depression disorder, attention deficit/hyperactivity disorder, or other issues 9. are taking foods or supplements that may affect cognitive function, such as docosahexaenoic acid, eicosapentaenoic acid, ginkgo leaf extract, tocotrienols, astaxanthin, gamma-aminobutyric acid, phosphatidylserine, or plasmalogens 10. are taking blue-backed fish such as sardines, mackerel, or saury at least four times a week 11. use devices, equipment, and applications that may affect cognitive functions (e.g., brain training puzzles, brain training games) 12. currently smoke or have quit smoking within one year prior to providing consent for this study 13. drink alcoholic beverages excessively 14. are on a diet or engage in strenuous exercise for the purpose of physical strengthening 15. have an irregular lifestyle due to shift work or other reasons 16. are taking anticoagulants such as warfarin 17. are pregnant, lactating, or planning to become pregnant during this study 18. 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 19. are judged as ineligible to participate in this study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary cognitive function test | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary cognitive function tests, peripheral blood tests, urinalysis, physical measurements, and adverse events | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed