Healthy Japanese
Conditions
Sponsors
Yotsuba Milk Products Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Japanese 2. Men or women 3. Adults 4. Healthy individuals 5. Individuals whose subjective fatigue measured by visual analogue scale (VAS) increases after Uchida-Kraepelin test 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 medications (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 drink to excess (average of more than about 20 g/day as pure alcohol intake) {500 mL: a medium bottle of beer or about 1.5 cans of canned chu-hi, 180 mL: 1 go of sake or about 1.5 glasses of wine, 90 mL: half-go with shochu, 60 mL: a glass of whiskey brandy (double)} 13. Individuals who are pregnant, lactating, or planning to become pregnant during this study 14. 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 subjective fatigue at eight weeks after the intervention (8w) (before-to-after psychological stress loading) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The change and percentage change of subjective fatigue at 8w (before-to-after psychological stress loading) from screening (Scr) (before-to-after psychological stress loading) 2. The measured value of subjective fatigue at 8w (before psychological stress loading), as well as change and percentage change from Scr (before psychological stress loading) 3. The measured value of subjective fatigue at 8w (after psychological stress loading), as well as change and percentage change from Scr (after psychological stress loading) 4. Individuals who experienced adverse events 5 Individuals whose values of urinalysis and peripheral blood test are outside the reference range after intervention despite within the reference range at screening 6. Physical measurements, urinalysis, and peripheral blood test | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed