Effects of consumption of the test food on skin in healthy Japanese

UMIN ID: UMIN000055571

Registered date:20/09/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Healthy Japanese
• Date of first enrollment: 2024/09/20
• Target sample size: 58
• 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 transepidermal water loss (TEWL) at 12 weeks after consumption (12w)
• Secondary Outcome: 1. The measured values of viscoelasticity of the skin (R0~R9), moisture content of skin, and cheek blood flow 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
• Age maximum: Not applicable
• Gender: Female
• 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. take foods/beverages with rich polyphenol including grapes, wine, grape juice (such as cacao, citrus fruit, or black tea) on a daily basis 14. 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 15. are pregnant, lactating, or planning to become pregnant during this study 16. 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 17. are judged as ineligible to participate in this study by the physician

Related Information

• Primary Sponsor: ORTHOMEDICO Inc.
• 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