UMIN ID: UMIN000055572
Registered date:20/09/2024
Effects of consumption of the test food on skin in healthy Japanese
Basic Information
Recruitment status | Recruiting |
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Health condition(s) or Problem(s) studied | Healthy Japanese |
Date of first enrollment | 2024/09/20 |
Target sample size | 76 |
Countries of recruitment | Japan |
Study type | Interventional |
Intervention(s) | Duration: 12 weeks Test food: Active food Duration: 12 weeks Test food: Placebo food |
Outcome(s)
Primary Outcome | 1. The measured value of viscoelasticity of the skin (R7) at 12 weeks after consumption (12w) |
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Secondary Outcome | 1. The measured values of transepidermal water loss (TEWL), viscoelasticity of the skin (R0~R6, R8, R9), and moisture content of skin at 12w 2. Individuals whose responses to an original questionnaire improved by one or more scales at 12w compared to screening (before consumption) |
Key inclusion & exclusion criteria
Age minimum | 18years-old |
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Age maximum | Not applicable |
Gender | Male and Female |
Include criteria | |
Exclude criteria | Individuals who 1. are undergoing medical treatment or have a medical history of malignant tumor, heart failure, or 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, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. are taking "Foods for Specified Health Uses" or "Foods with Functional Claims" 5. are taking or using medications (including herbal medicines) and supplements 6. are allergic to medicines and foods related to the test product 7. engage in occupations involving outdoor work 8. plan to take trips that will expose them to a lot of sunlight, such as swimming in the sea during this study 9. have been diagnosed with atopic dermatitis 10. 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 11. habitually receive skincare treatment (e.g., aesthetic treatment) or use instruments for beauty treatment (e.g., facial treatment device) 12. have undergone cosmetic surgery 13. are required to receive long-term drug treatment that may affect allergic symptoms of the nose and eyes (antiallergic drugs, antihistamines, steroids, vasoconstrictors, antihypertensives, etc.) during the study or, plan to take long-term drug treatment 14. are pregnant, lactating, or planning to become pregnant during this study 15. have been enrolled in other clinical studies within the last 28 days before the agreement to participate in this study or plan to participate in another study during this study 16. are judged as ineligible to participate in this study by the physician |
Related Information
Primary Sponsor | ORTHOMEDICO Inc. |
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Secondary Sponsor | Hiroo Dermatology Clinic & Mentors inc. Medical Corporation Seishinkai, Takara Clinic Nerima Medical Association, Minami-machi Clinic |
Source(s) of Monetary Support | NOF CORPORATION |
Secondary ID(s) |
Contact
public contact | |
Name | Naoko Suzuki |
Address | 2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan Japan 112-0002 |
Telephone | 03-3818-0610 |
nao@orthomedico.jp | |
Affiliation | ORTHOMEDICO Inc. R&D Department |
scientific contact | |
Name | Tatsuya Izumi |
Address | 1 & 2F Hiroo Masugi Annex Bldg., 5-25-5, Hiroo, Shibuya-ku, Tokyo, Japan Japan |
Telephone | 03-5795-1112 |
dr_izumi@orthomedico.jp | |
Affiliation | Hiroo Dermatology Clinic & Mentors inc. Director |