Healthy individuals (Intended indications and effects: Improvement of concentration)
Conditions
Interventions
Test food: Ginger extract powder
Duration: 12 weeks
Administration: Take one capsule per day in the morning.
Test food: Placebo
Duration: 12 weeks
Administration: Take one capsule per day in the morn
Sponsors
Takara Tsuyoshi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Japanese 2. Men or women 3. Adults 4. Healthy individuals 5. Individuals whose scoring of Mini Mental State Examination (MMSE) is 24 or more at screening (before intervention; Scr) 6. Individuals who feel eye strain and a decline in concentration when performing visual display terminals (VDT) operation 7. Individuals whose binocular visual acuity is 1.0 or better with the unaided eye or corrected eye and who do not wear contact lenses or wear contact lenses but can change to glasses during this study 8. Individuals whose standardized score of complex attention at Scr decline significantly from before to after workload with the VDT among study participants
Exclusion criteria
Exclusion criteria: 1. Individuals who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction 2. Individuals who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Individuals who are currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. Individuals who are taking "Foods for Specified Health Uses" or "Foods with Functional Claims" 5. Individuals who are taking or using medications (including herbal medicines) or supplements 6. Individuals who are allergic to medicines or foods related to the test products 7. Individuals who are pregnant, lactating, or planning to become pregnant during this study 8. Individuals who 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 9. Individuals who cannot stop taking caffeine or energy drinks at the day before and the day of the examination 10. Individuals who are diagnosed with presbyopia or aware of their presbyopia 11. Individuals who have eye disease, entropion, or trichiasis 12. Individuals who use eye drops due to eye diseases 13. Individuals with refractive errors that have not been properly corrected 14. Individuals who have undergone LASIK 15. Individuals who have severe astigmatism 16. Individuals who are taking foods or supplements that may affect cognitive functions daily (such as docosahexaenoic acid (DHA), eicosapentaenoic acid (EPA), ginkgo leaf extract, tocotrienol, astaxanthin, gamma-aminobutyric acid (GABA), phosphatidylserine, plasmalogen) 17. Individuals who have dementia 18. Individuals who have mental health issues such as depression disorder, attention deficit/hyperactivity disorder (ADHD), or other issues 19. Individuals who have irregular sleeping time or habit due to work such as a late-night shift 20. Individuals who are judged as ineligible to participate in this study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The measured value of standardized score in complex attention at 12 weeks after intervention (12w) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The amount and rate of change from Scr of standardized score of complex attention at 12w 2. The measured values of standardized score of neurocognition index (NCI), composite memory, verbal memory, visual memory, psychomotor speed, reaction time, cognitive flexibility, processing speed, executive function, social acuity, reasoning, working memory, sustained attention, simple attention, and motor speed at 12w, and the amount and rate of changes of them from Scr 3. The measured values of flicker values (average of both eyes, dominant eye, and non-dominant eye) at 12w (before and after VDT workload), and the amount of changes of them from Scr | — |
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc.
Outcome results
None listed