Tokyo, Nov. 19 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059808) titled 'Parallel-group comparative study on the skin moisturizing effects of PapriX(R) oral intake' on Nov. 18.

Study Type: Interventional

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

Primary Sponsor: Institute - Glico Nutrition Co., Ltd.

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

Objective: Narrative objectives1 - To verify the effects of consumption of the test product on skin in healthy Japanese. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Duration: Eight weeks Test product: Soft capsule containing PapriX(R) (xanthophyll derived from red bell pepper) Administration: Consume one capsule per day with water at dinner.

*If a dose is missed, it should be consumed as soon as remembered. The daily dose should be consumed within the same day and should not be carried over to the following day. Interventions/Control_2 - Duration: Eight weeks Test product: Soft capsule not containing PapriX(R) Administration: Consume one capsule per day with water at dinner.

*If a dose is missed, it should be consumed as soon as remembered. The daily dose should be consumed within the same day and should not be carried over to the following day.

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 whose TEWL (arm) is high at screening (Scr) Key exclusion criteria - 1. Individuals who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, or myocardial infarction

2. Individuals who have a pacemaker or an implantable cardioverter defibrillator (ICD)

3. Individuals who 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. Individuals who are taking "Foods for Specified Health Uses" or "Foods with Functional Claims"

5. Individuals who are taking medicines (including herbal medicines) or supplements

6. Individuals who have been diagnosed with atopic dermatitis

7. Individuals who use any products except for cosmetic creams, beauty essence, all-in-one cosmetic makeup, face masks, skin lotions, milky lotions, and sunscreen for daily skincare

8. Individuals who habitually receive skincare treatment (e.g., aesthetic treatment) or use instruments for beauty treatment (e.g., facial treatment device)

9. Individuals who have undergone cosmetic surgery

10. Individuals who are allergic to medicines or foods related to the test product (particularly, green pepper or bell pepper)

11. Individuals who are pregnant, lactating, or planning to become pregnant during this study

12. Individuals who 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

13. Individuals who receive hormone replacement therapy

14. Individuals whose lifestyle may majorly change (such as long-term travel) during this study

15. Individuals who are judged as ineligible to participate in this study by the physician Target Size - 38

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 18 Day Last follow-up date - 2026 Year 03 Month 24 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068389

Disclaimer: Curated by HT Syndication.