Healthy adults
Conditions
Interventions
Duration: 8 weeks Test product: Product containing water soluble polyphenol Administration: Consume one tablet three times daily (breakfast, lunch, or dinner, in total three tablets a day) with wat
Sponsors
Toyo Sugar Refining Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Japanese 2. Men or women 3. Adults 4. Healthy individuals 5. Individuals whose total score of the Mini Mental State Examination-Japanese (MMSE-J) is 24 or more at Scr 6. Individuals who are judged as eligible to participate in the study by the physician according to the results of the Beck Depression Inventory-II (BDI-II) at Scr 7. Individuals who are judged not to have an autism spectrum disorder including high-functioning autism or Asperger's syndrome, based on their responses to the Japanese version of the AQ at Scr 8. Individuals who are judged not to have ADHD based on their responses to the Japanese version of the CAARS at Scr 9. Individuals whose validity indicator for complex attention on Cognitrax is "Yes" at Scr 10. Individuals whose standardized score of complex attention on Cognitrax is < 100 at Scr
Exclusion criteria
Exclusion criteria: 1. Individuals who are receiving treatment for or have a history of malignant tumors, heart failure, or myocardial infarction 2. Individuals who have an implanted pacemaker or implantable cardioverter defibrillator 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 have dementia or a history of psychiatric disorders, such as depression disorder or ADHD 5. Individuals who consume Foods for Specified Health Uses or Foods with Functional Claims 6. Individuals who are taking or using medications (including herbal medicines) or supplements 7. Individuals who regularly consume foods or supplements that may affect cognitive function, such as docosahexaenoic acid (DHA) or eicosapentaenoic acid (EPA) 8. Individuals who take blue-backed fish such as sardines, mackerel, and saury at least four times a week 9. Individuals who use tools, devices, or applications that may affect cognitive function 10. Individuals who are allergic to medications or foods related to the test product 11. Individuals with irregular sleeping duration or patterns due to night shifts or similar work, or with irregular lifestyles 12. Individuals who currently smoke or began smoking cessation within three months before providing informed consent 13. Individuals who habitually drink >= 60 g/day of alcohol 14. Individuals who are pregnant, lactating, or planning pregnancy during this study 15. Individuals who are deemed unsuitable for participation in this study by the principal investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The measured value of the standardized score of complex attention on Cognitrax at 8 weeks after consumption (8w) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The changes and percentage changes of the standardized scores of complex attention on Cognitrax from screening (Scr) at 8w 2. The measured values of the standardized scores of each cognitive domain {neurocognition index (NCI), complex attention, 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} on Cognitrax, and the changes and percentage changes of them from Scr 3. The measured values of inattention / memory problems, hyperactivity/restlessness, impulsivity/emotional lability, problems with self-concept, Diagnostic and Statistical manual of Mental disorders-IV (DSM-IV) inattentive-type symptoms, DSM-IV hyperactive-impulsive-type symptoms, DSM-IV attention-deficit hyperactivity disorder (ADHD) symptoms total, and ADHD index of the Conners' Adult ADHD Rating Scales (CAARS), and the changes and percentage changes of them from Scr 4. Individuals whose responses to each item in the CAARS improved by one or more scales at 8w 5. The measured values of the Autism-spectrum Quotient (AQ) score, social skill, attention switching, attention to detail, communication, and imagination of the AQ, and the changes and percentage changes of them from Scr 6. Individuals whose responses to each item in the AQ improved by one or more scales at 8w 7. Individuals who experienced adverse events 8. Individuals whose values of urinalysis and peripheral blood test are outside the reference range after intervention despite within the reference range at Scr 9. Physical measurements, urinalysis, and peripheral blood test | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed