NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
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
Health condition(s) or Problem(s) studiedHealthy Japanese
Date of first enrollment2024/09/20
Target sample size76
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Duration: 12 weeks Test food: Active food Duration: 12 weeks Test food: Placebo food

Outcome(s)

Primary Outcome1. The measured value of viscoelasticity of the skin (R7) at 12 weeks after consumption (12w)
Secondary Outcome1. 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 minimum18years-old
Age maximumNot applicable
GenderMale and Female
Include criteria
Exclude criteriaIndividuals 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

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
E-mail 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
E-mail dr_izumi@orthomedico.jp
Affiliation Hiroo Dermatology Clinic & Mentors inc. Director