Healthy Japanese
Conditions
Interventions
Duration: Eight weeks Test food: Active food a
Duration: Eight weeks Test food: Placebo food
Sponsors
ORTHOMEDICO Inc.
Hiroo Dermatology Clinic &
Mentors inc. Medical Corporation Seishinkai, Takara Clinic Nerima Medical Association, Minami-machi Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Japanese 2. Men or women 3. Adults 4. Healthy individuals 5. Individuals who have skin type II or III on the Fitzpatrick Scale 6. Individuals who have relatively low MED at screening (before consumption) among those who met the inclusion criteria No. 1~5
Exclusion criteria
Exclusion criteria: Individuals (who) 1. are undergoing treatment or have a history of malignant tumor (including skin cancer), heart failure, myocardial infarction, or atopic dermatitis 2. have a pacemaker or an implantable cardioverter defibrillator 3. under 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. take "Foods for Specified Health Uses" or "Foods with Functional Claims" 5. take medications, herbal medicines, or supplements 6. are allergic to medicines, the test food related products, and/or crustaceans 7. engage in occupations involving outdoor work 8. plan outings or other activities, such as swimming in the sea, mountain climbing, or winter sports, involving a lot of sunlight during the study 9. use or practice daily skincare (e.g., body scrub, strigilation) except for cosmetic creams, beauty essence, all-in-one cosmetic makeup, skin lotions, face masks, milky lotions, and sunscreen 10. habitually receive skincare treatment (e.g., aesthetic treatment, massage) or use instruments for beauty treatment (e.g., facial treatment device) 11. have skin which always reddens and never darkens after sun exposure or tanning salon treatment, or have been pointed out by a third party for that 12. have developed urticaria after sun exposure or tanning salon treatment, or have been pointed out by a third party for that 13. are exposed to ultraviolet light (UV) daily (e.g., arc welding and fusing work, work under UV sterilization light, genetic testing work) 14. with art makeup or tattoos 15. are pregnant, lactating, or planning to become pregnant during the study 16. have been enrolled in other clinical studies within the last 28 days before the agreement to participate or plan to participate another study during the study 17. are judged as ineligible to participate in the study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The measured value of minimum erythema dose (MED) at eight weeks after consumption (8w) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The measured values of skin tone (L*-value, a*-value, b*-value), transepidermal water loss, skin moisture content, and viscoelasticity of skin at 8w 2. The measured value of original questionnaire at 8w | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed