Healthy Japanese
Conditions
Interventions
Duration: 12 weeks Test product: Capsule containing scallop extract Administration: Take two capsules per day with water before breakfast. *If you forget to take the test food, take it as soon as
Sponsors
B&S corporation 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 score of the Japanese version of the Mini Mental State Examination (MMSE-J) is 24 or more at screening 6. Individuals who have a "yes" in the validity indicator of verbal memory test on Cognitrax and the standardized score of verbal memory is less than 100 at screening
Exclusion criteria
Exclusion criteria: Individuals (who / whose) 1. are undergoing medical treatment or have a medical history of malignant tumor, heart failure, myocardial infarction, psychiatric disorder (including depressive symptoms), or cerebrovascular disease 2. have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. 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. have dementia 5. working pattern includes a late-night shift or early morning work 6. feel that their sleeping time are irregular 7. have a disability of both hands by injuries, surgeries, or other reasons 8. take "Foods for Specified Health Uses," "Foods with Functional Claims," or other functional foods/beverages 9. are taking or using medications (including herbal medicines) or supplements 10. take foods or supplements related to improving cognitive functions, such as docosahexaenoic acid, eicosapentaenoic acid, ginkgo leaf extract, tocotrienol, astaxanthin, gamma-aminobutyric acid, phosphatidylserine, or plasmalogen 11. take blue-backed fish such as sardines, mackerel, or saury at least four times a week 12. use devices, equipment, or applications that may affect cognitive functions (e.g., brain training puzzles or brain training games) 13. are allergic to medicines or foods related to the test product, particularly those who are allergic to shellfish or crustaceans such as shrimps and crabs 14. are pregnant, lactating, or planning to become pregnant during this study 15. 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 16. are judged as ineligible to participate in this study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The measured value of standardized score for verbal memory on Cognitrax at 12 weeks after intervention (12w) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The measured value of raw score for verbal memory on Cognitrax at 12w 2. The measured values of standardized scores and raw scores for each cognitive domain (except for verbal memory) and each test result on Cognitrax at 12w 3. The measured value of BDNF at 12w | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed