Healthy Japanese
Conditions
Interventions
Duration: 12 weeks Four candies per day containing Okinawan brown sugar
Duration: 12 weeks Four candies per day not containing Okinawan brown sugar
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. Individuals aged 40 or more 4. Healthy individuals 5. Individuals who notice a decline in memory 6. Individuals whose scoring of the Mini Mental State Examination (MMSE) is 24 or more at Scr 7. Individuals who have a "yes" in the validity indicator of the Cognitrax on both verbal memory and visual memory at Scr 8. Individuals who have a low standardized score in verbal memory of the Cognitrax at Scr
Exclusion criteria
Exclusion criteria: Individuals who 1.are under medical treatment or have a history of malignant tumor, heart failure, or myocardial infarction 2. have a pacemaker or an implantable cardioverter defibrillator 3. are under medical treatment for cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. take "Foods for Specified Health Uses" or "Foods with Functional Claims" 5. take or use medications (including herbal medicines) or supplements 6. are allergic to medicines and foods related to the test product, particularly who show allergic reactions to brown sugar and sugarcane 7. are pregnant, lactating, or planning to become pregnant during this study 8. 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. have dementia 10. have a history of depression, attention-deficit/hyperactivity disorder, or other psychiatric disorders 11. usually take foods or supplements that may affect cognitive functions, such as docosahexaenoic acid (DHA), eicosapentaenoic acid (EPA), ginkgo leaf extract, tocotrienol, astaxanthin, gamma-aminobutyric acid (GABA), phosphatidylserine, or plasmalogen 12. take blue-backed fish such as sardines, mackerel, or saury at least four times per week 13. use devices, equipment, and applications that may affect cognitive functions (such as brain training puzzles or brain training games) 14. have irregular sleeping time or habit due to work such as a late-night shift 15. are smokers or have quit smoking within 3 months before agreeing to participate 16. usually drink more than 60 g/day of alcohol 17. have irregular lifestyles (such as diet, exercise, or sleep) 18. have pollen allergy 19. are 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 change and percentage change from screening (before intervention; Scr) of the standardized score of verbal memory at 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 changes and percentage changes of them from Scr 3. The measured value of blood flow at 12w 4. The measured values of "eye fatigue," "coldness of fingertips," "coldness of whole body," "shoulder and neck stiffness," "facial swelling," "leg swelling," "sleepiness," "stress," "fatigue," "mouth dryness", and "skin dryness" measured by visual analogue scale (VAS) at 12w | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed