Tokyo, Nov. 27 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059890) titled 'Effects of consumption of the test food on the skin of healthy Japanese' on Nov. 26.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - ORTHOMEDICO Inc.

Condition: Condition - Healthy Japanese Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To verify the effects of consumption of the test food on the skin. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Duration: Eight weeks Test product: Test food

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1. Japanese 2. Men or women 3. Adults 4. Healthy individuals 5. Individuals who have recently experienced skin problems Key exclusion criteria - 1. Individuals currently undergoing treatment or with a medical history of malignant tumor, heart failure, or myocardial infarction 2. Individuals with a pacemaker or implantable cardioverter defibrillator 3. Individuals currently undergoing treatment for chronic diseases such as cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, or other chronic diseases 4. Individuals taking Foods for Specified Health Uses or Foods with Functional Claims 5. Individuals taking medicines (including herbal medicines) or supplements 6. Individuals with a history of atopic dermatitis 7. Individuals using daily skincare products other than toners, lotions, or sunscreen, such as creams, serums, all-in-one products, and masks 8. Individuals regularly receiving skincare treatments (e.g., aesthetic procedures) or using beauty devices (e.g., facial devices) 9. Individuals with a history of cosmetic surgery 10. Individuals who have undergone any procedures in the past 3 months that may affect the evaluation site, such as hormone replacement therapy, cosmetic procedures, or treatments for diseases requiring hospitalization 11. Individuals at risk of seasonal allergy symptoms, such as hay fever, during the study 12. Individuals whose lifestyle patterns may vary during the study (e.g., night shifts, business trips, or travel) 13. Individuals unable to refrain from deliberate exposure to sunlight, such as sunbathing, during the study 14. Individuals with allergies to medicines or foods related to the test product, particularly cacao allergy 15. Individuals who are pregnant, lactating, or planning to become pregnant during the study period 16. Individuals who participated in another clinical study within 28 days before consent or plan to participate in another study during the study 17. Individuals considered ineligible for the study by the principal investigator Target Size - 10

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2025 Year 11 Month 12 Day Date of IRB - 2025 Year 11 Month 12 Day Anticipated trial start date - 2025 Year 11 Month 26 Day Last follow-up date - 2026 Year 04 Month 05 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068486

Disclaimer: Curated by HT Syndication.