Healthy Japanese
Conditions
Interventions
Duration: 12 weeks Test food: Active food 1
Duration: 12 weeks Test food: Active food 2
Duration: 12 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 whose the transepidermal water loss is relatively high at screening (before consumption) among those who meet inclusion criteria No.1~4 without meeting any of exclusion criteria
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 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 medications (including herbal medicines) and supplements 6. Individuals who are allergic to medicines and/or the test food related products 7. Individuals who engage in occupations involving outdoor work 8. Individuals who plan to take trips that will expose them to a lot of sunlight, such as swimming in the sea during this study 9. Individuals who have been diagnosed with atopic dermatitis 10. 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 11. Individuals who habitually receive skincare treatment (e.g., aesthetic treatment) or use instruments for beauty treatment (e.g., facial treatment device) 12. Individuals who have undergone cosmetic surgery 13. Individuals who take grapes, wine, grape juice, or foods/beverages with rich polyphenol (such as cacao, citrus fruit, or black tea) on a daily basis 14. Individuals who are pregnant, lactating, or planning to become pregnant during this study 15. 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 16. 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 the transepidermal water loss at 12 weeks after consumption (12w) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The amount and rate of change of the transepidermal water loss between screening (before consumption; Scr) and 12w 2. The measured value of the transepidermal water loss at eight weeks after consumption (8w), and the amount and rate of change of it from Scr 3. The measured values of the moisture of the skin, viscoelasticity of the skin, and cheek blood flow at 8w and 12w, and the amount and rate of changes of them from Scr 4. The measured values of original questionnaire ("I feel my skin lacks moisture", "I feel my skin is stiff", "I feel my skin texture is rough", "I feel sagging of the skin", "I feel my skin has no firmness", "I feel my skin has less elasticity", "I feel wrinkles on my face are noticeable", "I feel my skin tone is dark", "I feel cold", and "I feel like my face swells easily") at 8w and 12w | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed