UMIN ID: UMIN000049525
Registered date:18/11/2022
Verification study on the effect of intake of test foods on skin barrier function
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | Not applicable |
| Date of first enrollment | 2022/11/19 |
| Target sample size | 200 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Daily intake of test food for 12 weeks Daily intake of placebo (control food) for 12 weeks |
Outcome(s)
| Primary Outcome | Transedermal water loss (TEWL) |
|---|---|
| Secondary Outcome | Water content Elasticity Skin texture Skin wrinkles Skin tone Skin Surface Gloss Melanin Collagen Score Skindex-16 Likert Scale Questionnaire POMS2 d-ROMs BAP Simple OSP (urinary 8-OHdG/creatinine corrected, PAO) Oxidized LD |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | Not applicable |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 1. Persons who are on treatment for a serious illness. 2. Persons with or treating skin disease. 3. Persons who can be expected to have hay fever during the study. 4. Persons who had procedures that may affect the study. 5. Persons with food allergies or those who may be allergic to the test food. 6. Persons who regularly use licensed drugs or quasi-drugs that may affect the study. 7. Persons who regularly use health foods that may affect the study. 8. Persons who are participating in a clinical trial or have participated in another clinical trial within 3 months from the date of obtaining consent. 9. Persons with excessive sunburn. 10. Persons who intentionally cannot refrain from exposure to direct sunlight during the study. 11. Smokers, or non-smokers who have not smoked within 3 months prior to the start of the study. 12. Persons who receive skin care treatments or use beauty devices daily. 13. Experience in cosmetic surgery. 14. Persons unable to maintain daily routines. 15. Pregnant, lactating, or wishing to become pregnant. 16. Persons who plan to participate in other examinations during the study. 17. Other subjects who are deemed inappropriate for this study by the investigator. |
Related Information
| Primary Sponsor | APO PLUS STATION CO., LTD. |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Nissin York Co., Ltd. |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Ryoko Koizumi |
| Address | 2-14-1,Nihonbashi,Chuo-ku,Tokyo, Japan Japan 103-0027 |
| Telephone | 03-6386-8809 |
| food-contact@apoplus.co.jp | |
| Affiliation | APO PLUS STATION CO., LTD. CRO Department Clinical Operations Division |
| scientific contact | |
| Name | Shuichi Segawa |
| Address | 272, Tsutsumine, Kamimurakimi, Hanyu, Saitama, Japan Japan |
| Telephone | 048-565-4686 |
| shuichi.segawa@nissin.com | |
| Affiliation | Nissin York Co., Ltd. Development Laboratories |