Healthy Japanese
Conditions
Interventions
Duration: 12 weeks Test product: Tablet containing high-dose S-allylcysteine (SAC) extract powder Administration: Take six tablets per day with water within 30 minutes after breakfast. If you do not
Sponsors
Bizen Chemical Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Japanese 2. Men or women 3. Individuals aged 45 or older and younger than 70 4. Healthy individuals 5. Individuals who are aware of a decline in memory 6. Individuals whose Mini Mental State Examination (MMSE) is 24 or higher at screening 7. Individuals whose validity indicators for both the Verbal Memory and Visual Memory Tests on Cognitrax are marked as "Yes" at screening 8. Individuals whose standardized score in Verbal Memory of Cognitrax is less than 100 at screening
Exclusion criteria
Exclusion criteria: Individuals who 1. are under treatment or have a history of malignant tumor, heart failure, or myocardial infarction 2. have a pacemaker or an implantable cardioverter defibrillator 3. are under 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. take "Foods for Specified Health Uses" or "Foods with Functional Claims" 5. take or use medicines (including herbal medicines) or supplements 6. are allergic to medicines or foods related to the test product (particularly, onion, garlic chives, or garlic) 7. are pregnant, lactating, or planning to become pregnant during this study 8. 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. have dementia 10. have a history of mental disorder (e.g., depression or attention-deficit/hyperactivity disorder) 11. regularly consume foods with rich procyanidins (e.g., apples, black soybeans, cacao) 12. regularly consume foods or supplements that may affect cognitive function (e.g., docosahexaenoic acid, eicosapentaenoic acid, ginkgo leaf extract, tocotrienols, astaxanthin, gamma-aminobutyric acid, phosphatidylserine, plasmalogen) 13. consume blue-backed fish at least four times a week (e.g., sardines, mackerel, saury) 14. use devices, equipment, or applications that may affect cognitive functions (e.g., brain training puzzles or brain training games) 15. have irregular sleeping time or habit due to work (e.g., late-night shift) 16. are smokers or have quit smoking within the last three months before the agreement to participate in this study 17. consume alcohol excessively (>=60 g/day) 18. have irregular lifestyles (e.g., diet, exercise, sleep) 19. 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 for Composite Memory on Cognitrax at 12 weeks after consumption (12w) [High-dose group vs. Placebo group; Low-dose group vs. Placebo group] | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The measured values of the standardized scores for each cognitive domain (excluding Composite Memory) and each test result on Cognitrax at 12w 2. The measured values of low frequency (LF), high frequency (HF), LF/HF ratio, average heart rate, maximum heart rate, minimum heart rate, total power (TP), coefficient of component variance total power (ccvTP), deviation value of autonomic nervous function, and autonomic functional age measured by VM302 at 12w 3. The measured values of d-ROMs, BAP, high-sensitivity CRP, ApoA-1, TTR, C3, IL-1 alpha, IL-1 beta, TNF alpha, IL-6, CXCL1, CXCL2, G-CSF, CCL5, testosterone, dihydrotestosterone, p-TAU217, amyloid beta 42, and NAD+ at 12w 4. The bacterial occupancy rate in feces and the alpha diversity index at 12w | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed