Healthy Japanese
Conditions
Interventions
Duration: 12 weeks Test food: Active food
Duration: 12 weeks Test food: Placebo food
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 70 4. Healthy individuals 5. Individuals whose scoring of MMSE is 24 or more at screening (before consumption; Scr) 6. Individuals who have a "yes" in the validity indicator of Cognitrax on both verbal memory and visual memory at Scr 7. Individuals who have relatively low standardized score in composite memory measured using Cognitrax at Scr among those meeting No.1~6 of the inclusion criteria and not meeting the exclusion criteria
Exclusion criteria
Exclusion criteria: Individuals who 1. are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction 2. have a pacemaker or an implantable cardioverter defibrillator 3. are currently undergoing treatment for cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, autoimmune disease, hemorrhagic disease, or any other chronic diseases 4. are taking "Foods for Specified Health Uses" or "Foods with Functional Claims" 5. are taking medications, herbal medicines, or supplements 6. are allergic to medicines and/or the test food related products 7. are pregnant, lactating, or planning to become pregnant during the study 8. have been enrolled in other clinical studies within 28 days before agreeing to participate or plan to participate another study during the study 9. have dementia 10. have a medical history of mental disorder (e.g., depression disorder, attention deficit/hyperactivity disorder) 11. usually take procyanidins-rich foods (e.g., apple, black soybean, cacao) 12. usually take foods or supplements that may affect cognitive functions (e.g., DHA, EPA, ginkgo leaf extract, tocotrienol, astaxanthin, GABA, phosphatidylserine, plasmalogen) 13. take blue-backed fish (e.g., sardines, mackerel, saury) at least 4 times a week 14. use devices, equipment, and applications that may affect cognitive functions (e.g., brain training puzzles or games) 15. have irregular sleeping time or habit due to night shift or other reasons 16. are smokers or have quit smoking within 3 months before agreeing to participate 17. usually drink more than 60 g/day of alcohol 18. have irregular lifestyles (e.g., diet, exercise, sleep) 19. have pollen allergy 20. may undergo surgery (including tooth extraction, endoscopic examination, or others) during the study or within 4 weeks after the end of consumption 21. are judged as ineligible to participate by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Cognitrax at 12 weeks after consumption (12w) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Mini Mental State Examination (MMSE) at 12w 2. Salivary testosterone at 12w 3. Total testosterone and free testosterone at 12w | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed