UMIN ID: UMIN000057287
Registered date:19/06/2026
Evaluation of skin condition improvement by ingestion of the test product
Basic Information
| Recruitment status | Pending |
|---|---|
| Health condition(s) or Problem(s) studied | N/A(healthy adults) |
| Date of first enrollment | 2025/03/17 |
| Target sample size | 52 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Oral intake of test food once daily for 8 weeks Oral intake of placebo food once daily for 8 weeks |
Outcome(s)
| Primary Outcome | Skin elasticity (Week 0, Week 8) |
|---|---|
| Secondary Outcome | Skin moisture content Skin blood flow Subjective skin evaluation (Week 0, Week 8) |
Key inclusion & exclusion criteria
| Age minimum | 35years-old |
|---|---|
| Age maximum | 59years-old |
| Gender | Male and Female |
| Include criteria | 1) Healthy Japanese males and females aged 35 to 59 years old 2) Subjects who feel dry skin 3) Subjects who feel loss in skin elasticity 4) Subjects who feel rough skin |
| Exclude criteria | 1) Subjects who spend a lot of time outdoors or exposed to ultraviolet rays in their daily lives (e.g., those who work night shifts or day/night shifts, those who engage in sales or delivery work, etc.) 2) Subjects who take or apply medications (e.g., medicines with moisturizing effects) that may affect test results 3) Subjects who regularly use specified health foods, functional foods (e.g., food containing sodium hyaluronate, glucosylceramide, astaxanthin), or health foods (including supplements) that may affect the improvement of skin quality and who are unable to discontinue from the time consent is obtained 4) Subjects who have undergone facial beauty treatments or beauty clinics within 2 weeks prior to the start of the examination 5) Subjects who are taking or will take medication for hay fever 6) Subjects who can be allergic to the test food 7) Subjects who may show allergic symptoms to any of the ingredients in the test product 8) Subjects with asthma 9) Subjects who are a smoker 10) subjects who cannot intentionally refrain from direct exposure to the sun, such as sunburns and long-term travel between pre-inspection and the end of the examination 11) Subjects who have irregular lifestyle habits, such as waking and sleeping times that vary by 4 hours or more depending on the day of the week 12) Pregnant or possibly pregnant, and lactating mothers 13) Subjects who have skin allergy symptoms or skin hypersensitivity 14) Subjects who have chronic inflammation of the skin such as atopic dermatitis 15) Subjects who have chronic diseases and regularly use drugs 16) Subjects who have remarkable abnormality on skin condition of the test area 17) Subjects who participate in other clinical trials |
Related Information
| Primary Sponsor | Shiba Palace Clinic |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Hayashikane Sangyo Co., Ltd. |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Yoshiaki Inoue |
| Address | 2-4-8 Yamatomachi, Shimonoseki-Shi, Yamaguchi, JAPAN Japan 750-8608 |
| Telephone | 083-267-0094 |
| yinoue@hayashikane.com | |
| Affiliation | Hayashikane Sangyo Co., Ltd. functional food division |
| scientific contact | |
| Name | Takashi Koikeda |
| Address | DaiwaA Hamamatsucho Bldg. 6F, 1-9-10, Hamamatsucho, Minato-ku, Tokyo, 105-0013, JAPAN Japan |
| Telephone | 03-5408-1599 |
| jimukyoku@mail.souken-r.com | |
| Affiliation | Shiba Palace Clinic Chair |