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 among those who provided informed consent whose TMD score of the Profile of Mood States 2nd Edition (POMS2) increased after psychological stress loading at screening 6. Individuals among those who met inclusion criteria No. 1-5 and did not meet any of the exclusion criteria, whose TMD score in the POMS2 is relatively high after psychological stress loading 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 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 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. Measured value of Total Mood Disturbance (TMD) at eight weeks after the intervention (8w) (after psychological stress loading) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change and percentage change in TMD from screening (after psychological stress loading) to 8w (after psychological stress loading) 2. Measured value of TMD at four weeks after the intervention (4w) and 8w (before psychological stress loading), as well as changes and percentage changes from screening (before psychological stress loading) 3. Change and percentage change in TMD from screening (before-to-after psychological stress loading) to 8w (before-to-after psychological stress loading) 4. Measured values of Anger-Hostility (AH), Confusion-Bewilderment (CB), Depression-Dejection (DD), Fatigue-Inertia (FI), Tension-Anxiety (TA), Vigor-Activity (VA), Friendliness (F), subjective fatigue, and salivary cortisol at 8w (after psychological stress loading), as well as changes and percentage changes from screening (after psychological stress loading) 5. Measured values of AH, CB, DD, FI, TA, VA, F, subjective fatigue, and salivary cortisol at 4w and 8w (before psychological stress loading), as well as changes and percentage changes from screening (before psychological stress loading) 6. Measured values of AH, CB, DD, FI, TA, VA, F, subjective fatigue, and salivary cortisol at 8w (before-to-after psychological stress loading), as well as changes and percentage changes from screening (before-to-after psychological stress loading) 7. Measured values of Depression score, Anxiety score, and Stress score of the Depression Anxiety Stress Scales-21 (DASS-21); total score of the Beck Depression Inventory-Second Edition (BDI2); and total score, Somatic Symptoms (A scale), Anxiety and Insomnia (B scale), Social Dysfunction (C scale), and Severe Depression (D scale) of the General Health Questionnaire-28 (GHQ-28) at 4w and 8w, as well as changes and percentage changes from screening | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed