Healthy Japanese
Conditions
Interventions
Duration: Eight weeks Test product: Capsule containing rice bran extract Administration: Take two capsules per day with water without chewing. *If you forget to take the test food, take it as soo
Sponsors
NOF CORPORATION
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Japanese 2. Men or women 3. Adults 4. Healthy individuals 5. Individuals whose T score of VA in POMS2 is less than 60 at screening (Scr) 6. Individuals who met the inclusion criteria 1~5 and have high T score of FI in POMS2 at Scr
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 are taking "Foods for Specified Health Uses" or "Foods with Functional Claims" 5. Individuals who are taking or using medicines (including herbal medicines) or supplements 6. Individuals who are allergic to medicines or foods related to the test product 7. Individuals who have mental health issues such as depression disorder, attention deficit/hyperactivity disorder (ADHD), or other issues 8. Individuals who have irregular sleeping time or habit due to work such as a late-night shift 9. Individuals who have irregular lifestyles (such as diet, exercise, and sleep) 10. Individuals who are undergoing medical treatment for chronic fatigue syndrome or menopausal syndrome 11. Individuals who work in physical labor such as transportation of heavy objects 12. Individuals who answered that there had been major changes or events in their life at questionnaire of Scr 13. Individuals who are pregnant, lactating, or planning to become pregnant during this study 14. 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 15. 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-Inertia (FI) in the Profile of Mood States 2nd Edition (POMS2) at eight weeks after intervention (8w) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The measured values of Total Mood Disturbance (TMD) score, Anger-Hostility (AH), Confusion-Bewilderment (CB), Depression-Dejection (DD), Tension-Anxiety (TA), Vigor-Activity (VA), and Friendliness (F) in the POMS2 at 8w | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed