Tokyo, Oct. 21 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059473) titled 'Evaluation of the effect of a test product on the skin maintenance of skin elasticity' on Oct. 21.
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 test product on the skin elasticity in men and women aged 35 to 50.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Ingestion of active beverage for 12 weeks
Interventions/Control_2 - Ingestion of placebo beverage for 12 weeks
Eligibility:
Age-lower limit - 35
years-old
=
Gender - Male and Female
Key inclusion criteria - 1.Healthy Japanese men and women aged 35 to 50 at the time of obtaining consent to participate in the study
2.Individuals who are concerned about skin elasticity
Key exclusion criteria - 1. Individuals currently receiving outpatient treatment and using medications
2. Individuals consuming vegetable or vegetable-fruit mix juice three or more times per week
3. Individuals consuming either carrots, pumpkin, spinach, or chrysanthemum greens a total of at least three or more times per week
4. Individuals currently consuming supplements containing carotenoids three or more times per week
5. Individuals currently consuming medications, quasi-drugs, specific health foods, nutritional supplements, functional foods, or so-called health foods that claim skin elasticity improvement, moisturizing effects, or estrogen-like effects at least three times per week
6. Individuals unable to refrain from activities involving excessive UV exposure beyond daily life during the study period.
7. Individuals who have undergone cosmetic procedures on the measurement site
8. Individuals who have received body esthetic treatments on the measurement site within the past month
9. Individuals with chronic skin conditions such as atopic dermatitis
10. Individuals with abnormalities on the measurement site, such as wounds or inflammation
11. Smokers
12. Individuals with a physical constitution that may interfere with blood collection
13. Individuals at risk of showing allergic symptoms upon food
14. Individuals whose average weekly alcohol consumption, converted to pure alcohol, exceeds 40 g/day for men and 20 g/day for women
15. Individuals with asthma
16. Individuals with hay fever
17. Individuals with a BMI below 18.5 or above 25.0
18. Individuals planning overseas travel or extended domestic travel during the study period
19. Individuals working night shifts or rotating shifts
20. Women who are pregnant, breastfeeding, or planning to become pregnant during the study period
21. Individuals participating in another clinical study within the past three months
22. Any other individuals deemed ineligible for this study by the principal investigator
Target Size - 80
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 10 Month 20 Day
Date of IRB - 2025 Year 10 Month 20 Day
Anticipated trial start date - 2025 Year 12 Month 03 Day
Last follow-up date - 2026 Year 03 Month 10 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068022
Disclaimer: Curated by HT Syndication.