A verification study of the anti-ultraviolet light effects of the test food
- Conditions
- Healthy Japanese
- Registration Number
- JPRN-UMIN000053035
- Lead Sponsor
- ORTHOMEDICO Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 44
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. The measured value of minimum erythema dose (MED) at eight weeks after consumption (8w)
- Secondary Outcome Measures
Name Time Method 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