Healthy Japanese adult people
Conditions
Interventions
Duration: 12 weeks Test material: Capsule containing astaxanthin and tocotrienol Administration: Take one capsule during or after breakfast * If you forget to take the test food, take it as soon as
Sponsors
ORTHOMEDICO Inc.
Medical Corporation Seishinkai, Takara Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy Japanese adult people who are experiencing memory loss 2. Subjects who are judged as eligible to participate in the study by the physician 3. Meeting the 2nd criteria requirement, subjects who get 24 or more in score of Mini Mental State Examination (MMSE) 4. Meeting the 3nd criteria requirement, subjects who has relatively low standardized score in composite memory by Cognitrax
Exclusion criteria
Exclusion criteria: 1. At least one previous medical history of malignant tumor, heart failure or myocardial infarction 2. Undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver failure, kidney failure, cerebrovascular disease, rheumatism, diabetes mellitus, dyslipidemia, hypertension or any other chronic diseases 3. Subjects who have dementia 4. Subjects who have mental health issues such as depression disorder, depression disorder, attention deficit/hyperactivity disorder (ADHD), or other issues 5. Currently taking medications (include herbal medicines), "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage 6. Subjects who take supplements related to improving cognitive functions, such as docosahexaenoic acid (DHA), eicosapentaenoic acid (EPA), ginkgo leaf extract, tocotrienol, astaxanthin, gamma-aminobutyric acid (GABA), and phosphatidylserine in daily 7. Subjects who are allergic to medicines and/or the test food related products 8. Subjects who are pregnant, lactation, and planning to become pregnant 9. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial 10. Subjects who are judged as ineligible to participate in the study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite memory * Assessed by Cognitrax * Perform Cognitrax at screening and examination before consuming and at 8 and 12 weeks after ingestion | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Neurocognitive index 2. Verbal memory 3. Visual memory 4. Psychomotor speed 5. Reaction time 6. Complex attention 7. Cognitive flexibility 8. Processing speed 9. Executive function 10. Social acuity 11. Reasoning 12. Working memory 13. Sustained attention 14. Simple attention 15. Motor speed 16. Subjective symptoms 17. Brain-derived neurotrophic factor (BDNF) concentration in blood 18. Propanoyl lysine (PRL) concentration in blood 19. Pentosidine concentration in blood *1-15 Assessed by Cognitrax *16 Assessed by Likert scale *1-19 Perform the tests at screening and examination before consuming and at 8 and 12 weeks after ingestion | — |
Countries
Japan
Contacts
Public ContactNaoko SUZUKI
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed