Healthy Japanese
Conditions
Interventions
Duration: 12 weeks Test product: Capsule containing coffee cherry pulp extract Administration: Take one capsule per day with water. *If you forget to take the test food, take it as soon as you re
Sponsors
UCC UESHIMA COFFEE CO., LTD.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Japanese 2. Men or women 3. Individuals aged 40 years or older 4. Healthy individuals 5. Individuals whose MMSE score is 24 or higher at screening 6. Individuals whose validity indicators for both the Verbal Memory and Visual Memory on Cognitrax are marked as "Yes" at screening 7. Individuals whose standard score in Verbal Memory of Cognitrax is 89 or lower at screening
Exclusion criteria
Exclusion criteria: Individuals who 1. are undergoing medical treatment or have a medical history of malignant tumor, heart failure, or myocardial infarction 2. have a pacemaker or an implantable cardioverter defibrillator 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. are taking "Foods for Specified Health Uses" or "Foods with Functional Claims" 5. are taking or using medications (including herbal medicines) or supplements 6. are allergic to medicines or foods related to the test product 7. have dementia 8. have a history of mental disorder such as depression or attention-deficit/hyperactivity disorder (ADHD) 9. take foods or supplements that may affect cognitive function, such as docosahexaenoic acid (DHA), eicosapentaenoic acid (EPA), ginkgo leaf extract, tocotrienols, astaxanthin, gamma-aminobutyric acid (GABA), phosphatidylserine, and plasmalogen 10. take blue-backed fish such as sardines, mackerel, and saury at least four times a week 11. use devices, equipment, or applications that may affect cognitive functions (e.g., brain training puzzles or brain training games) 12. have irregular sleeping time or habit due to work, such as a late-night shift 13. have a large variation in their daily smoking amount 14. have a large variation in their daily alcohol consumption 15. have irregular lifestyles (such as diet, exercise, and sleep) 16. have caffeine sensitivity 17. take beverages with rich caffeine, such as coffee or energy drink in daily 18. are pregnant, lactating, or planning to become pregnant during this study 19. 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 20. are judged as ineligible to participate in this study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The measured value of the standard score of Verbal Memory at 12 weeks after intervention (12w) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The measured values of the standard score of each cognitive domain (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) and the score of Mini Mental State Examination (MMSE) at 12w | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed