Effects of consumption of the test food on skin condition in healthy Japanese subjects
- Conditions
- Healthy Japanese subjects
- Registration Number
- JPRN-UMIN000046714
- Lead Sponsor
- ORTHOMEDICO Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 56
Not provided
1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction 2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Subjects currently undergoing treatment for any of the following chronic disease: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. Subjects who use or take "Foods for Specified Health Uses," "Foods with Functional Claims," or other functional food/beverage in daily 5. Subjects who currently taking medications (including herbal medicines) and supplements (particularly including docosahexaenoic acid and/or eicosapentaenoic acid) 6. Subjects who are allergic to medicines and/or the test food related products 7. Subjects who have been diagnosed with atopic dermatitis 8. Subjects 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 9. Subjects who habitually receive skincare treatment (e.g., aesthetic treatment) or use instruments for beauty treatment (e.g., facial treatment device) 10. Subjects who have undergone cosmetic surgery 11. Subjects who are aspirin-intolerance or currently taking medications including aspirin 12. Subjects who are pregnant, lactation, or planning to become pregnant 13. Subjects who suffer from COVID-19 14. Subjects who have been enrolled in other clinical trials within the last 28 days before the agreement to participate in this trial or plan to participate another trial during this trial 15. Subjects who 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 viscoelasticity of the skin (cheek) at six weeks after consumption (6w)
- Secondary Outcome Measures
Name Time Method 1. The measured value of viscoelasticity of the skin (back of the hands) at 6w 2. The measured value of viscoelasticity of the skin (cheek and back of the hands) at four weeks after consumption (4w) 3. The amount of change from screening (before consumption; Scr) of viscoelasticity of the skin (cheek and back of the hands) to 4w and 6w 4. The measured value and the amount of change from Scr of transepidermal water loss (cheek), water content (cheek), and dermal measurement (cheek and back of the hands) at 4w and 6w 5. The measured value and the amount of change from Scr of visual analog scale (VAS) score (skin moisture, skin roughness, skin texture, sagging of the skin, skin elasticity, skin viscoelasticity, and makeup condition), 1,5-anhydroglucitol (1,5-AG), and glycoalbumin at 6w