Healthy volunteer
Conditions
Interventions
Intake of test food for 8 weeks (1 capsule per day)
Intake of placebo food for 8 weeks (1 capsule per day)
Sponsors
SOUKEN Co., Ltd
Shiba Palace Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Healthy male and female aged from 20 to 59 years old at the time informed consent. 2) Subjects with fair or normal skin color 3) Subjects who are aware of skin roughened. 4) Subjects who can agree that circular sunburn marks (up to 12 on each side) will remain on the medial side of the upper arm for about half a year (depending on the skin type) 5) Subjects who are able to confirm 1 MED in any of the 6 irradiation fields by MED judgment. However, if the number of subjects who meet the conditions exceeds the number to be selected, the subjects who can confirm 1 MED with a smaller irradiation energy will be selected. 6) Subjects whose TEWL of inside the right forearm is relatively high at screening 7) Subjects who are healthy and have no problem in participating in the study judged by a doctor
Exclusion criteria
Exclusion criteria: 1) Subjects who may exhibit skin allergic symptoms or with skin hypersensitivity 2) Subjects who may show allergic symptoms due to the ingredients of the test product 3) Subjects undergoing hospital visits, medications, and treatment 4) Subjects who are pregnant, potentially pregnant or lactating 5) Subjects participating in other clinical trials 6) Subjects with chronic diseases or disorders of the liver / biliary tract / digestive system, circulatory / respiratory system, renal / urinary system, psychiatric / nervous system, blood system 7) Subjects with a history or present illness of hepatitis 8) Subjects whose lifestyle may change significantly during the test period (including overseas travel) 9) Subjects who continuously take functional foods and supplements that may affect test results (anti-inflammatory, whitening, skin turnover, etc.) 10) Subjects with UV damage, pigmentation (stains), skin diseases, etc. on the medial side of the left and right forearms 11) Subjects who have blisters due to sunburn 12) Subject with extremely thin upper arm 13) Subjects who are in a situation where sunburn is unavoidable due to long hours of outdoor work or sports from screening to the end of the test 14) Subjects who are smoker 15) Subjects who have been exposed to artificial UV radiation within the last two months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The measured values of Minimal Erythema Dose (MED) at 8 weeks after the start of test-food consumption | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The measured values of Minimal Erythema Dose (MED) at 4 weeks after the start of test-food consumption 2. The amount of changes of the measured values of MED between screening and at four and eight weeks after the start of test-food consumption. 3. The measured values of moisture of the skin, transepidermal water loss (TEWL), melanin index, erythema index, skin color (L*, a*, b*), minimal tanning dose (MTD) at four and eight weeks after the start of test-food consumption. 4. The amount of changes of the measured values of moisture of the skin, TEWL, melanin index, erythema index, skin color (L*, a*, b*), MTD at four and eight weeks after the start of test-food consumption. 5. The measured values of the questionnaire at four and eight weeks after the start of test-food consumption. | — |
Countries
Japan
Contacts
Public ContactKaneko Miwa
SOUKEN Co., Ltd Management Division
Outcome results
None listed