Healthy individuals (Intended indications and effects: Improvement of skin barrier function)
Conditions
Interventions
Test food: Bacillus subtilis subsp. natto QOL powder
Duration: 12 weeks
Administration: Consume one capsule per day after breakfast.
Test food: Dextrin
Duration: 12 weeks
Administration: Consume one
Sponsors
Izumi Tatsuya
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Japanese 2. Men or women 3. Adults 4. Healthy individuals 5. Individuals whose transepidermal water loss (TEWL) is high at screening (Scr) 6. Individuals whose "sleepiness on rising" (Zc score) in the OSA sleep inventory MA version (OSA-MA) is less than 50 at Scr 7. Individuals whose defecation frequency is three to five times during the week before Scr 8. Individuals who are judged as eligible to participate in this study by the physician according to the results of the Beck Depression Inventory-Second Edition (BDI-II) 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 undergoing medical treatment or have a medical history of any of the following diseases: mental disorders (e.g., depression), sleep apnea syndrome, hypersomnia, narcolepsy, insomnia, or valvular heart disease 5. Individuals who are taking "Foods for Specified Health Uses" or "Foods with Functional Claims" 6. Individuals who are taking or using medications (including herbal medicines) or supplements 7. Individuals who usually take medicines, health foods, "Foods for Specified Health Uses," or "Foods with Functional Claims," that may affect bowel movement / take foods fortified with ingredients affecting bowel movement (e.g., fermented foods such as natto, kimchi, and pickles, foods fortified with dietary fiber, and dairy products such as yogurt, fermented milk, and cheese) 8. Individuals who have been diagnosed with atopic dermatitis 9. Individuals who use any products except for cosmetic creams, beauty essence, all-in-one cosmetic makeup, skin lotions such as face masks, milky lotions, and sunscreen for daily skincare 10. Individuals who habitually receive skincare treatment (e.g., aesthetic treatment) or use instruments for beauty treatment (e.g., facial treatment device) 11. Individuals who have undergone cosmetic surgery 12. Individuals who have habits of consuming foods or using devices to improve sleep 13. Individuals whose sleeping habits are irregular due to night shifts and other lifestyle reasons 14. Individuals who fall under the following sleeping conditions: sleeping in the same room with two or more people, living with preschool-aged children, living with individuals who require nursing care, or having their sleep potentially disturbed by the influence of others 15. Individuals who have nocturia two times or more 16. Individuals who are allergic to medicines or foods related to the test product (particularly, natto) 17. Individuals who are pregnant, lactating, or planning to become pregnant during this study 18. 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 19. Individuals who usually drink to excess (average of more than about 20 g/day as absolute 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)} 20. 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 TEWL at 12 weeks after intervention (12w) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The measured value of the moisture content of skin surface at 12w 2. The measured values of viscoelasticity of skin (R0~R9) at 12w 3. The measured values of Intensity, Skin Thickness, and Low Echogenic Band (LEB) at 12w 4. The measured values of the defecation frequency, defecation days, and the amount of defecation in period 2~13* 5. Individuals whose stool shape, stool smell, and exhilarating feeling of defecation improved one or more scales in period 2~13* compared to period 1* 6. The measured values of Zc score of "sleepiness on rising," "initiation and maintenance of sleep," "frequent dreaming," "refreshing," and "sleep length" at 12w *Period 1: 7 days prior to Scr *Period 2~13: Periods separated by 7 days from the start of intervention | — |
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc.
Outcome results
None listed