Healthy Japanese subjects
Conditions
Interventions
Duration: Eight weeks Test food: Beverage containing functional ingredients derived from sake Administration: Take one bottle after waking up once a day *If you forget to take the test food, take
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 subjects 5. Subjects whose skin viscoelasticity is relatively low at screening (before consumption)
Exclusion criteria
Exclusion criteria: Subjects who 1. are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction 2. have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. are currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. use or take "Foods for Specified Health Uses," or "Foods with Functional Claims" in daily 5. are currently taking medications (including herbal medicines) and supplements 6. are allergic to medications and/or the test-food-related products (particularly alcohol) 7. are pregnant, lactating, or planning to become pregnant during this trial 8. suffer from COVID-19 9. 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 10. are judged as ineligible to participate in this study by the physician 11. have been diagnosed with atopic dermatitis 12. habitually receive skincare treatment (e.g., aesthetic treatment) or use instruments for beauty treatment (e.g., facial treatment device) 13. have undergone cosmetic surgery 14. usually take food/beverage containing functional ingredients which may influence skin (such as gamma-aminobutyric acid (GABA), isoflavones, lactic acid bacteria, bifidobacteria, eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA), astaxanthin, glucosylceramide, proteoglycans, piceatannol, lycoperosides, collagen peptide) 15. usually drink sake 16. usually drink mirin / intentionally use a lot of mirin in dishes 17. drink to excess (average of more than about 20 g/day as absolute alcohol intake) {500 mL: a medium bottle of beer or about 1.5 cans of canned chu-hi, 180 mL: about 1.5 glasses of wine, 90 mL: half-go with shochu, 60 mL: a glass of whiskey brandy (double)}
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Skin viscoelasticity at eight weeks after consumption (8w) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Skin viscoelasticity at four weeks after consumption (4w) 2. The moisture of the skin surface, transepidermal water loss, and dermis measurement {intensity, skin thickness, low echogenic band (LEB)} at 4w and 8w | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed