Healthy Japanese
Conditions
Interventions
Test food A 12 weeks
Test food B 12 weeks
Test food C 12 weeks
Placebo 12 weeks
Sponsors
ORTHOMEDICO Inc.
Hiroo Dermatology Clinic &
Mentors inc. Medical Corporation Seishinkai, Takara Clinic Nerima Medical Association, Minami-machi Clinic
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Japanese 2. Women 3. Adults 4. Healthy individuals 5. Individuals who defecate three to five times in seven days prior to Scr 6. Individuals whose TEWL is high at Scr among those who meet 5
Exclusion criteria
Exclusion criteria: Individuals who 1. are undergoing medical treatment or have a medical history of malignant tumor, heart failure, or myocardial infarction 2. have a pacemaker or an implantable cardioverter defibrillator 3. 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. are taking "Foods for Specified Health Uses (FOSHU)" or "Foods with Functional Claims (FFC)" 5. are taking or using medications and supplements 6. are allergic to medicines or foods related to the test product 7. are engaged in occupations involving outdoor work 8. plan to take trips that will expose them to a lot of sunlight, such as swimming in the sea during this study 9. have been diagnosed with atopic dermatitis 10. 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 11. habitually receive skincare treatment or use instruments for beauty treatment 12. have undergone cosmetic surgery 13. usually take foods containing rich in lactic acid bacteria (LAB), LAB-enriched health foods, or medicines 14. usually take medicines, health foods, FOSHU, or FFC, that may affect bowel movement / take foods fortified with ingredients affecting bowel movement 15. must continue using drug that may affect nasal and eye allergic symptoms during the study, or plan to do so 16. have been diagnosed with premenstrual syndrome or have skin problems before menstruation 17. are pregnant, lactating, or planning to become pregnant during this study 18. 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. are judged as ineligible to participate in this study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The measured values of transepidermal water loss (TEWL) at 12 weeks after the first consumption (12w) (The test food A vs. placebo, the test food B vs. placebo, and the test food C vs. placebo) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The measured values of defecation frequency, number of days with defecation, and amount of defecation in period 2~13* 2. Individuals whose stool shape, stool smell, and exhilarating feeling of defecation improved by >=1 scales in period 2~13* compared to period 1 * Period 1: 7 days prior to screening (before intervention; Scr) Period 2: For 7 days since the first consumption Period 3: 8~14 days after consumption Period 4: 15~21 days after consumption Period 5: 22~28 days after consumption Period 6: 29~35 days after consumption Period 7: 36~42 days after consumption Period 8: 43~49 days after consumption Period 9: 50~56 days after consumption Period 10: 57~63 days after consumption Period 11: 64~70 days after consumption Period 12: 71~77 days after consumption Period 13: From 78 days after consumption to the day before 12w | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed