Healthy Japanese subjects
Conditions
Interventions
Duration: 12 weeks Test food: Food containing sugarcane stem extract Administration: Take five capsules (100 mg sugarcane stem extract/capsule) with water after breakfast * If you forget to take
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 years old or more 4. Healthy subjects 5. Subjects who are aware of the decline in their memory function 6. Subjects who are judged as eligible to participate in the study by the physician 7. Subjects who are judged as eligible to participate in the study by the physician according to the results of Beck depression inventory (BDI)-II 8. Subjects who have a "yes" in the validity indicator of Cognitrax on both verbal memory and visual memory 9. Subjects who have 24 points or more of Mini Mental State Examination (MMSE) 10. Subjects who have a relatively low standardized score in composite memory by Cognitrax
Exclusion criteria
Exclusion criteria: 1. Subjects who have 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. Subjects who are 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 are smokers 7. Subjects who take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage in daily use 8. 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 use 9. Subjects who take blue-backed fish such as sardines, mackerel, and saury more than four days per week 10. Subjects who regularly use devices, equipment, and applications that may affect cognitive functions (e.g., brain training puzzles, brain training games) 11. Subjects who currently taking medicines (include herbal medicines) and supplements 12. Subjects who are allergic to medicines and/or the test food related products 13. Subjects who are pregnant, breast-feeding, or planning to become pregnant after the agreement to participate in this trial 14. 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 15. 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 (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 of the standardized scores of 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, and brain derived neurotrophic factor (BDNF) at 12w 3.The amount of change of the standardized scores of 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, and BDNF between Scr and 12w 4. The measured values of all of the items of an original qustionaires at 4, 8, and 12w | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed