Healthy Japanese subjects
Conditions
Interventions
Duration: 12 weeks Test food: Capsule containing lipid-soluble polyphenol Administration: Take one capsules per day after breakfast with water. *If you forget to take the test food, take it as so
Sponsors
ORTHOMEDICO Inc.
Medical Corporation Seishinkai, Takara Clinic Nerima Medical Association, Minami-machi Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy Japanese adult subjects 2. Subjects who are judged as eligible to participate in the study by the physician 3. Subjects who have a "yes" in the validity indicator of Cognitrax on both verbal memory and visual memory 4. Subjects who have 24 points or more of MMSE 5. 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. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Currently under the treatment for either cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension or other chronic diseases 4. Subjects who have dementia 5. Subjects who have mental health issues such as depression disorder, attention deficit/hyperactivity disorder (ADHD), or other issues 6. Subjects who use or take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage in daily 7. 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), phosphatidylserine, and plasmalogen in daily 8. Subjects who take blue-backed fish such as sardines, mackerel, and saury in daily 9. Subjects who regularly use devices, equipment, and applications that may affect cognitive functions (e.g., brain training puzzles, brain training games) 10. Currently taking medicines (include herbal medicines) and supplements 11. Subjects who are allergic to medicines and/or the test food related products 12. Subjects who are pregnant, breast-feeding, and planning to become pregnant 13. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial or plan to enroll in another clinical trial during trial period 14. Subjects who are judged as ineligible to participate in the study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The measured values of the standardized score of composite memory at 12 weeks after consumption | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The amount of change of the standardized score of composite memory between screening (before consumption) and 12 weeks after consumption 2. The measured values of the standardized scores of Neurocognition Index (NCI), composite memory, 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 at 12 weeks after consumption 3. The amount of change of the standardized scores of NCI, composite memory, 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 between screening (before consumption) and 12 weeks after consumption 4. The measured values of the brain derived neurotrophic factor (BDNF), amyloid beta, the scores of Total Mood Disturbance (TMD), Tension-Anxiety (TA), Depression-Dejection (DD), Anger-Hostility (AH), Vigor-Activity (VA), Fatigue-Inertia (FI), Confusion-Bewilderment (CB), and Friendliness (F), total score of self-administered dementia checklist, and the score of cognitive function and life function at 12 weeks after consumption 5. The amount of change of the BDNF, amyloid beta, the scores of TMD, TA, DD, AH, VA, FI, CB, and F, total score of self-administered dementia checklist, and the score of cognitive function and life function between screening (before consumption) and 12 weeks after consumption 6. The measured values of all of the items of POMS2 Japanese version at 12 weeks after consumption 7. The measured values of all of the items of self-administered dementia checklist at 12 weeks after consumption | — |
Countries
Japan
Contacts
Public ContactNaoko SUZUKI
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed