Healthy Japanese
Conditions
Interventions
Consumption of the test food for 12 weeks
Consumption of the placebo food for 12 weeks
Sponsors
ORTHOMEDICO Inc.
Medical Corporation Seishinkai, Takara Clinic Nerima Medical Association, Minami-machi Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Japanese 2. Men or women 3. Individuals aged between 40 and 65 4. Healthy individuals 5. Individuals who notice a decline in memory 6. Individuals whose scoring of Mini Mental State Examination (MMSE) is 24 or more at screening (before consumption; Scr) 7. Individuals who have a "yes" in the validity indicator of Cognitrax on both verbal memory and visual memory at Scr 8. Individuals whose standardized score in verbal memory measured using Cognitrax is 99 or less at Scr
Exclusion criteria
Exclusion criteria: 1. Individuals who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction 2. Individuals who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Individuals 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 take blue-backed fish such as sardines, mackerel, and saury 5. Individuals who take lactic acid bacteria beverages 6. Individuals who use devices, equipment, and applications that may affect cognitive functions (e.g., brain training puzzles, brain training games) 7. Individuals who use or take "Foods for Specified Health Uses" or "Foods with Functional Claims" 8. Individuals whose life rhythms are irregular due to working a late-night shift or others 9. Individuals who are smokers or have quit smoking within the last three months before the agreement to participate in this study 10. Individuals who are taking medications (including herbal medicines) and supplements 11. Individuals who are allergic to medicines and/or the test food related products 12. Individuals who are pregnant, lactating, or planning to become pregnant during this study 13. 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 another study during this study 14. Individuals who are judged as ineligible to participate in this study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The standardized scores of verbal memory at 12 weeks after consumption (12w) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The standardized scores of neurocognition index (NCI), composite memory, visual 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 2. Diacron reactive oxygen metabolites (d-ROM), biological antioxidant potential (BAP), and BAP/d-ROM at 12w | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed