Healthy Japanese subjects
Conditions
Interventions
Duration: 12 weeks Test food: Food containing Citrus depressa extract powder Administration: Take one capsule with water after breakfast * Daily dose should be taken within the day. If you forge
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 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 whose scoring of Mini Mental State Examinination (MMSE)-J is 24 or more 8. Subjects who have a "yes" in the validity indicator of Cognitrax on both verbal memory and visual memory 9. Subjects who have a relatively low standardized score of composite memory by Cognitrax
Exclusion criteria
Exclusion criteria: Subjects who 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. are currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disease, kidney disease, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. have dementia 5. have mental health issues such as depression disorder, attention deficit/hyperactivity disorder (ADHD), or other issues 6. are smoker at the time of the agreement to participate in this trial or plan to smoke during this trial 7. plan to have surgery from first consumption to two weeks after last consumption 8. take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage at least four times a week 9. take supplements related to improving cognitive functions, such as docosahexaenoic acid, eicosapentaenoic acid, ginkgo leaf extract, tocotrienol, astaxanthin, gamma-aminobutyric acid, phosphatidylserine, and plasmalogen at least four times a week 10. take blue-backed fish such as sardines, mackerel, and saury at least four times a week 11. use devices, equipment, and applications that may affect cognitive functions (e.g., brain training puzzles, brain training games) in daily 12. are currently taking medications (including herbal medicines) and supplements 13. are allergic to medications and/or the test-food-related products (particularly citrus fruit) 14. are pregnant, lactation, or planning to become pregnant 15. 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 16. are judged as ineligible to participate in the study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 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 at 12w 3. The amounts of changes 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 between Scr and 12w | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed