Healthy individuals (Intended indications and effects: Reduction of psychological stress)
Conditions
Interventions
Test food: Food containing Bacillus subtilis subsp. natto
Duration: Eight weeks
Administration: Take one capsule per day after breakfast.
Test food: Placebo
Duration: Eight weeks
Administration: Take
Sponsors
Takara Tsuyoshi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Japanese 2. Men or women 3. Adults 4. Healthy individuals 5. Individuals who are judged as eligible to participate in this study by the physician based on the result of the Beck Depression Inventory-II (BDI-II) at screening (before intervention; Scr) 6. Individuals who usually feel tired or stress easily due to desk work 7. The top 68 individuals with the highest Total Mood Disturbance (TMD) score in the Profile of Mood States 2nd Edition (POMS2) at Scr
Exclusion criteria
Exclusion criteria: 1. Individuals who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and 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 are pregnant, lactating, or planning to become pregnant during this study 8. 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 another study during this study 9. Individuals who have mental health issues such as depression disorder, attention deficit/hyperactivity disorder (ADHD), or other issues 10. Individuals whose working form includes late-night shift or early-morning shift 11. Individuals who feel their sleeping time is irregular 12. Individuals who feel whose lifestyles (such as diet, exercise, and sleep) are irregular 13. Individuals who live with their infants less than one year old 14. Individuals who sleep with their children (1 to 6 years old) 15. Individuals who take foods that they consider to have a relaxing effect once weekly or more 16. Individuals who use items that they consider to have a relaxing effect once weekly or more 17. 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 TMD at eight weeks after intervention (8w) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The measured values of Tension-Anxiety (TA), Depression-Dejection (DD), Anger-Hostility (AH), Vigor-Activity (VA), Fatigue-Inertia (FI), Confusion-Bewilderment (CB), and Friendliness (F) at 8w 2. The amount of changes from Scr of TMD, TA, DD, AH, VA, FI, CB, and F at 8w 3. The measured values and amount of changes from Scr of "sleepiness on rising," "initiation and maintenance of sleep," "frequent dreaming," "refreshing," "sleep length," and each item in the OSA sleep inventory MA version (OSA-MA) at 8w 4. The measured values and amount of changes from Scr of visual analog scale (VAS) at 8w | — |
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc.
Outcome results
None listed