Healthy adults
Conditions
Interventions
Duration: Eight weeks Test product: Modified polyphenol
Duration: Eight weeks Test product: Placebo
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 who are aware of frequently making decisions (the act of making various kinds of decisions) in daily life and who feel temporary fatigue due to decision-making 6. Individuals whose total score on the Japanese version of the Decision Fatigue Scale (DFS) is >= 15 and responses of >= 3 on at least five items of the DFS at screening 7. Individuals who are judged as eligible to participate in this study by the physician according to the results of the Beck Depression Inventory 2nd Edition (BDI-II) at screening 8. Individuals whose Mini-Mental State Examination (MMSE) score is >= 24 at screening 9. Individuals whose validity indicator for Reaction Time on Cognitrax is "Yes" at screening 10. Individuals whose standardized score of Reaction Time on Cognitrax is < 90 at screening 11. Individuals whose fatigue (VAS) is >= 50 mm at screening
Exclusion criteria
Exclusion criteria: 1. Individuals who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, or 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 have dementia or a history of psychiatric disorders, such as depression disorder or attention-deficit/hyperactivity disorder (ADHD) 5. Individuals who are taking "Foods for Specified Health Uses" or "Foods with Functional Claims" 6. Individuals who are taking or using medicines (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 medicines 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 to become pregnant during this study 15. 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 16. 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 fatigue by Visual Analogue Scale (VAS) at 8 weeks after intervention (8w) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The measured value of the standardized scores of Reaction Time at 8w, and their change and percentage change from screening 2. The change and percentage change from screening of mental fatigue due to numerous decisions (VAS) at 8w 3. Number of individuals whose response to "feeling mental fatigue due to numerous decisions," "feeling head fatigue," "difficulty in thinking," "low concentration," "low attention," and "low motivation" at 8w, and responses to each item improved by one or more levels at 8w compared with screening 4. The measured values of the standardized scores of Neurocognition Index (NCI), Composite Memory, Verbal Memory, Visual Memory, Psychomotor Speed, Complex Attention, Cognitive Flexibility, Processing Speed, Executive Function, Social Acuity, Reasoning, Working Memory, Sustained Attention, Simple Attention, and Motor Speed at 8w, and their changes and percentage changes from screening | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed