Tokyo, Dec. 31 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000055873) titled 'Clinical trial to confirm the effect of test product intake on improving skin moisture' on Dec. 31.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - SHISEIDO CO., LTD.
Condition:
Condition - None
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - Confirm the effectiveness of ingesting the test product for 12 weeks on the skin.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Continuous consumption for 12 weeks of a beverage containing the test substance
Interventions/Control_2 - Continuous consumption for 12 weeks of Placebo beverage
Eligibility:
Age-lower limit - 35
years-old
=
Gender - Female
Key inclusion criteria - Persons who meet all of the following conditions will be selected.
1.Individuals who have expressed a desire to participate in the study, understood the explanation, and can provide written consent to participate in the study
2. Healthy Japanese women aged 35-50
3. Individuals who are aware of a lack of vegetables
4. Individuals who are concerned about a decrease in skin elasticity
5. Individuals with a regular lifestyle (those who wake up in the morning and go to bed at night, with relatively regular wake-up and bedtimes)
6. Individuals who are able to fill out documents such as consent forms, questionnaires, and test product intake diaries
Key exclusion criteria - Those who meet even one of the following conditions will be excluded.
1. Taking medicines, foods for specified health uses, functional foods, health foods, or beauty supplements that claim to have moisturizing effects, skin elasticity maintenance effects, or estrogen-like effects (3 times or more per week)
2. Taking supplements containing carotenoids (3 times or more per week)
3. Taking concentrated mixed vegetable juice, mixed vegetable and fruit juice, tomato juice, carrot juice, orange juice, green juice, or mango juice (3 times or more per week)
4. Taking carrots, pumpkin, spinach, or chrysanthemums (3 times or more per week)
5. Having significant abnormalities in the skin condition of the test site
6. Having had cosmetic medical treatment that could affect the test site
7. Having not yet received facial or body beauty treatment for more than one month ago
8. Atopic dermatitis, etc. 9. Currently visiting a doctor and using medicines
10. BMI is less than 18.5 and more than 25
11. Smoker
12. Excessive alcohol intake
13. Asthma
14. Hay fever
15. Pregnant or planning to be pregnant, or breastfeeding
16. Currently participating in a study involving the ingestion of other beverages or medicines, or a study involving the application of cosmetics or medicines, or participating in a similar study and having completed the study more than 3 months ago
17. May develop allergic symptoms from ingesting the test product
18. Planning to travel overseas or take a long domestic trip during the study period
19. Night shift or two-shift work (different from the daily rhythm of waking up in the morning and going to bed at night)
20. Other subjects that the study director or study manager deems inappropriate (uncooperative subjects, etc.)
Target Size - 40
Recruitment Status:
Recruitment status - Completed
Date of protocol fixation - 2024 Year 10 Month 02 Day
Date of IRB - 2024 Year 10 Month 09 Day
Anticipated trial start date - 2024 Year 11 Month 09 Day
Last follow-up date - 2025 Year 03 Month 30 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063855
Disclaimer: Curated by HT Syndication.
