Healthy Japanese subjects
Conditions
Interventions
Duration: 12 weeks Test food: Capsule containing plant-derived extract Administration: Take four capsules per day with water after breakfast *If you forget to take the test food, take it as soon
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 who notice a decline in memory 6. Subjects whose scoring of Mini Mental State Examination (MMSE) is 24 or more at screening (before consumption; Scr) 7. Subjects who have a "yes" in the validity indicator of Cognitrax on both verbal memory and visual memory at Scr 8. Subjects who met the inclusion criteria 1~7 and have relatively low standardized score in composite memory measured using Cognitrax at Scr
Exclusion criteria
Exclusion criteria: 1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction 2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Subjects 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. Subjects who have a past or current medical history of hemorrhagic disease or convulsive disorder 5. Subjects who plan to undergo surgery between two weeks prior to the agreement to participate in this trial and two weeks posterior to completion of consumption 6. Subjects who use or take "Foods for Specified Health Uses," or "Foods with Functional Claims" in daily 7. Subjects who are currently taking medications (including herbal medicines) and supplements 8. Subjects who are allergic to medicines and/or the test food related products (particularly, rosemary or aspirin) 9. Subjects who are pregnant, lactating, or planning to become pregnant during this trial 10. Subjects who 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 11. Subjects who are judged as ineligible to participate in this study by the physician 12. Subjects who usually take supplements or foods that may be 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 13. Subjects who usually take blue-backed fish such as sardines, mackerel, and saury 14. Subjects who usually use devices, equipment, and applications that may affect cognitive functions (e.g., brain training puzzles, brain training games)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The standardized score of composite memory at 12 weeks after consumption (12w) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. 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} at 12w 2. Each score of the MOS Short-Form 36-Item Health. Survey (SF-36) {Physical Component Summary (PCS), Mental Component Summary (MCS), Role-social Component Summary (RCS), Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional, Mental Health} at 12w | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed