Tokyo, Sept. 2 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058953) titled 'Evaluation of the effect of plant-derived ingredient on the skin moisturizing function and safety' on Sept. 1.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Double blind -all involved are blinded Control - Placebo

Primary Sponsor: Institute - KAGOME CO., LTD.

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

Objective: Narrative objectives1 - To assess the effect of a plant-derived ingredient on the skin moisturizing effects and long-term safety in healthy Japanese men and women aged 20 years or older. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Ingestion of plant-derived ingredient capsules for 12 weeks Interventions/Control_2 - Ingestion of placebo capsules for 12 weeks

Eligibility: Age-lower limit - 20 years-old

Gender - Male and Female Key inclusion criteria - 1.Healthy Japanese men and women aged 20 to 59 at the time of obtaining consent to participate in the study 2.Individuals who are concerned about dry or flaky skin Key exclusion criteria - 1.Individuals currently suffering from any chronic illness and receiving treatment or medication 2.Individuals undergoing hormone replacement therapy 3.Individuals with chronic skin conditions such as atopic dermatitis 4.Individuals who have a habit if ingesting or applying medications for disease treatment within the past month 5.Individuals with severe anemia 6.Individuals at risk of allergic reactions to food or medications 7.Individuals who currently have, or have had within the past three months, a habit of consuming medications, quasi-drugs, specific health foods, nutritional supplements, functional foods, or so-called health foods that claim to have skin moisturizing effects 8.Individuals whose average weekly alcohol consumption, converted to pure alcohol, exceeds 40 g/day for men and 20 g/day for women 9.Individuals with a smoking habit 10.Individuals who work night shifts 11.Individuals whose lifestyle habits may change during the study period 12.Individuals who may experience itching or other symptoms at the evaluation areas due to seasonal allergic symptoms such as hay fever during the study period. Additionally, individuals who may take anti-allergic medications or use nasal sprays 13.Individuals who cannot avoid intentional exposure to direct sunlight, such as sunbathing, during the study period 14.Individuals who have undergone cosmetic procedures in the evaluation areas 15.Individuals using medications, quasi-drugs, or cosmetics with strong moisturizing effects or potential effects on wrinkles 16.Individuals with abnormalities such as wounds or inflammation in the evaluation areas 17.Women who are pregnant, breastfeeding, or planning to become pregnant during the study period 18.Individuals currently participating in other clinical studies or those who have participated in other clinical studies within the past three months 19.Any other individuals deemed ineligible for this study by the principal investigator Target Size - 74

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 08 Month 29 Day Date of IRB - 2025 Year 08 Month 29 Day Anticipated trial start date - 2026 Year 01 Month 25 Day Last follow-up date - 2026 Year 04 Month 23 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067423

Disclaimer: Curated by HT Syndication.