Healthy Japanese subjects
Conditions
Interventions
Period I. the test food Period II. control food * The intervention sequence is Period I to II. * Washout period is for approximately 1 week.
Period I. control food Period II. the test food *
Sponsors
ORTHOMEDICO Inc.
Medical Corporation Seishinkai, Takara Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Subjects who use Japanese as his/her primary language 2.Subjects who are judged as healthy by the physician from screening (scr) test
Exclusion criteria
Exclusion criteria: Subjects who 1. cannot identify color 2. have difficulty taking cognitive function tests because of weak sight or hearing 3. have 26 scores or less of MMSE 4. have a symptom, have been diagnosed, have a history, and/or have a daily medication for the following items: amblyopia, blindness, deafness, anacusis, cerebral nervous disease, cardiac disorder, depressive symptoms, depression, menopausal syndrome, sleep-related diseases, cardiac arrhythmia, and/or serious disease 5. are receiving hormonal therapy, or treatment related to cognitive function 6. have a pacemaker 7. sometimes have irregular lifestyles during study 8. have the following situation more than once a week: [taking drugs, or health foods that influence cognitive function, autonomic nerve activity, or improving sleep], or [taking foods resembling test food or energy drink] 9. having a habit of drinking beverages relating test foods more than once a month, regardless of amount, or cannot abstain from drinking the beverages between 1 week before scr test and the end of the test period 10. regularly drink alcohol beyond proper quantity 11. are smokers, or started smoking cessation within the last 12 months before scr 12. have experienced cognitive function tests within the last 12 months before scr 13. have donated whole blood or got a blood transfusion within the last 3 months before scr 14. have been enrolled in other clinical trials within the last 1 month before scr, or planning to participate during the test period 15. have a risk of allergies to the test food 16. are pregnant or lactation 17. are judged inappropriate as subjects from answers to lifestyle questionnaires 18. are not successfully taken his/her data of autonomic nerve activity at scr 19. or whose family who living together work at a company developing and manufacturing functional foods 20. plan to do the following during the test period: go abroad, donate blood, pregnant or lactation 21. are judged as unsuitable by doctor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Heart rate variability | — |
Secondary
| Measure | Time frame |
|---|---|
| Neuropsychological tests for cognitive functions Visual Analogue Scale (VAS) of fatigue | — |
Countries
Japan
Contacts
Public ContactNaoko SUZUKI
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed