Tokyo, June 19 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000057287) titled 'Evaluation of skin condition improvement by ingestion of the test product' on June 19.

Study Type: Interventional

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

Primary Sponsor: Institute - Shiba Palace Clinic

Condition: Condition - N/A(healthy adults) Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - Evaluate the effect of the test product ingestion on skin condition improvement Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Oral intake of test food once daily for 8 weeks Interventions/Control_2 - Oral intake of placebo food once daily for 8 weeks

Eligibility: Age-lower limit - 35 years-old = Gender - Male and Female Key inclusion criteria - 1) Healthy Japanese males and females aged 35 to 59 years old 2) Subjects who feel dry skin 3) Subjects who feel loss in skin elasticity 4) Subjects who feel rough skin Key exclusion criteria - 1) Subjects who spend a lot of time outdoors or exposed to ultraviolet rays in their daily lives (e.g., those who work night shifts or day/night shifts, those who engage in sales or delivery work, etc.) 2) Subjects who take or apply medications (e.g., medicines with moisturizing effects) that may affect test results 3) Subjects who regularly use specified health foods, functional foods (e.g., food containing sodium hyaluronate, glucosylceramide, astaxanthin), or health foods (including supplements) that may affect the improvement of skin quality and who are unable to discontinue from the time consent is obtained 4) Subjects who have undergone facial beauty treatments or beauty clinics within 2 weeks prior to the start of the examination 5) Subjects who are taking or will take medication for hay fever 6) Subjects who can be allergic to the test food 7) Subjects who may show allergic symptoms to any of the ingredients in the test product 8) Subjects with asthma 9) Subjects who are a smoker 10) subjects who cannot intentionally refrain from direct exposure to the sun, such as sunburns and long-term travel between pre-inspection and the end of the examination 11) Subjects who have irregular lifestyle habits, such as waking and sleeping times that vary by 4 hours or more depending on the day of the week 12) Pregnant or possibly pregnant, and lactating mothers 13) Subjects who have skin allergy symptoms or skin hypersensitivity 14) Subjects who have chronic inflammation of the skin such as atopic dermatitis 15) Subjects who have chronic diseases and regularly use drugs 16) Subjects who have remarkable abnormality on skin condition of the test area 17) Subjects who participate in other clinical trials Target Size - 52

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 01 Month 14 Day Date of IRB - 2025 Year 01 Month 30 Day Anticipated trial start date - 2025 Year 03 Month 17 Day Last follow-up date - 2025 Year 06 Month 19 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065424

Disclaimer: Curated by HT Syndication.