Healthy Japanese subjects
Conditions
Interventions
Duration: 12 weeks Test food: Coffee cherry pulp extract (low amount)
Duration: 12 weeks Test food: Coffee cherry pulp extract (high amount)
Duration: 12 weeks Test food: Dextrin powder
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. Subjects aged 40 or more 4. Healthy subjects 5. Subjects whose scoring of MMSE is 24 or more and 27 or less at Scr 6. Subjects who have a "yes" in the validity indicator of Cognitrax on both verbal memory and visual memory at Scr 7. Subjects who have relatively low standardized score in composite memory measured using Cognitrax at Scr
Exclusion criteria
Exclusion criteria: Subjects (who/whose) 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 (ICD) 3. currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. use or take "Foods for Specified Health Uses," or "Foods with Functional Claims" in daily 5. are currently taking medications (including herbal medicines) and supplements 6. are allergic to medicines and/or the test food related products 7. are pregnant, lactating, or planning to become pregnant during this trial 8. have been enrolled in other clinical trials within the last 28 days before the agreement to participate in this trial or plan to participate another trial during this trial 9. have dementia 10. have mental health issues such as depression disorder, attention deficit/hyperactivity disorder (ADHD), or other issues 11. take supplements related to improving cognitive functions, such as docosahexaenoic acid (DHA), eicosapentaenoic acid (EPA), ginkgo leaf extract, tocotrienol, astaxanthin, gamma-aminobutyric acid (GABA), phosphatidylserine, and plasmalogen 12. take blue-backed fish such as sardines, mackerel, and saury at least four times a week 13. use devices, equipment, and applications that may affect cognitive functions (e.g., brain training puzzles, brain training games) 14. sleeping time or habit is irregular due to work such as a late-night shift 15. amount of smoking varies widely from day to day 16. alcohol intake varies widely from day to day 17. have irregular lifestyles (such as diet, exercise, and sleep) 18. have caffeine sensitivity 19. take beverages with rich caffeine, such as coffee or energy drink in daily 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 standardized score of composite memory at 12 weeks after consumption (12w) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The amount of change of the standardized score of composite memory between screening (before consumption; Scr) and 12w 2. The measured values and the amount of changes from Scr of the standardized scores of each cognitive domain {neurocognition index (NCI), verbal 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}, Mini Mental State Examination (MMSE) score, and brain derived neurotrophic factor (BDNF) at 12w | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed