Healthy Japanese
Conditions
Interventions
Duration: 12 weeks Test product: Tablet containing ripened Korean red ginseng extract powder Administration: Take three tablets per day at any time during the day. *If you forget to take the test
Sponsors
KIM's Korean Ginseng Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Japanese 2. Men or women 3. Individuals aged 40 or more 4. Healthy individuals 5. Individuals who are aware of a decline in memory (e.g., difficulty finding or recalling words) 6. Individuals whose scoring of Mini Mental State Examination (MMSE) is 24 or more at Scr 7. Individuals whose validity indicator for Verbal Memory on Cognitrax is marked as "yes" at Scr 8. Individuals whose standardized score of Verbal Memory on Cognitrax is less than 90 at Scr
Exclusion criteria
Exclusion criteria: Individuals who 1. under treatment or have a history of malignant tumor, heart failure, or myocardial infarction 2. have a pacemaker or an implantable cardioverter defibrillator 3. under treatment for cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. have dementia 5. have a history of mental health issues (e.g., depression disorder, attention deficit/hyperactivity disorder), reflux esophagitis, HIV, mitochondrial toxicity, long-term hepatitis C liver disease, hypercholesterolemia, chronic renal failure, valve replacement surgery, coronary artery stent, or gastric bypass surgery 6. need to take antipyretic analgesic (e.g., acetaminophen or ibuprofen) for a long term 7. take a large amount of caffeine (more than 3~4 cups a day) 8. are smokers or have not completed one year since starting to quit smoking 9. take "Foods for Specified Health Uses" or "Foods with Functional Claims" 10. take supplements or foods that may be related to improving cognitive functions (e.g., docosahexaenoic acid, eicosapentaenoic acid, ginkgo leaf extract, tocotrienol, astaxanthin, gamma-aminobutyric acid, phosphatidylserine, or plasmalogen) 11. take blue-backed fish (e.g., sardines, mackerel, or saury) at least four times a week 12. use devices, equipment, or applications that may affect cognitive functions (e.g., brain training puzzles or brain training games) 13. take or use medicines (including herbal medicines) or supplements 14. are allergic to medicines or foods related to the test food (particularly ginseng (Korean ginseng)) 15. are pregnant, lactating, or planning to become pregnant during this study 16. 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 17. 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 Verbal Memory at 12 weeks after intervention (12w) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The amount and percentage of change of the standardized score of Verbal Memory from screening (Scr) to 12w 2. The measured values of the standardized scores 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} at 12w, and the amount and percentage of changes of them from Scr 3. The measured values of Physical Component Summary (PCS), Mental Component Summary (MCS), Role/Social Component Summary (RCS), Physical Functioning (PF), Role Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VTPF), Social Functioning (SF), Role Emotional (RE), and Mental Health (MH) at 12w | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed