Tokyo, Sept. 6 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059007) titled 'Research on the effects of fermentable dietary fiber and behavioral intervention on the skin' on Sept. 5.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Uncontrolled
Primary Sponsor:
Institute - Healthcare Systems Co., Ltd.
Condition:
Condition - Healthy Adults
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To evaluate the effects on skin condition of adult women aged 20 to under 50 years old who take in foods containing fermented dietary fiber and undergo behavioral intervention (face massage and cotton packs) for 12 consecutive weeks at 6 weeks and 12 weeks.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Intake of foods containing fermented dietary fiber and behavioral intervention (face massage and cotton packs) for 12 weeks.
Eligibility:
Age-lower limit - 20
years-old
Gender - Female
Key inclusion criteria - 1. Persons who received a sufficient explanation of the purpose and contents of the exam, have the capacity to consent, applied with free will with sufficient understanding, and agreed to participate with a written document
2. Japanese women who are 20 years old or more and under 50 years old
3. Persons who have concerns about their skin
4. Persons who have concerns about their gastrointestinal health
Key exclusion criteria - 1. Persons who have chronic illness, receiving medication, have a serious disease history
2. Persons who are allergic to the test food (especially wheat, eggs, milk, soybeans, peaches, almonds, and oranges)
3. Persons who usually take a large amount of the test food
4. Persons who regularly do facial massages
5. Persons who regularly use face masks
6. Persons who don't regularly use lotion
7. Persons who usually take a large amount of dietary fiber
8. Persons who usually take medicine, specified health food, healthy food and supplements that may have the skin condition or other supplements that are expected to have cosmetic effects
9. Persons who regularly use vitamin A (tretinoin, retinol, retinol analogues) in their skin care
10. Persons who usually take medicine, specified health food, healthy food and supplements that may have the intestinal environment or other supplements that are expected to have cosmetic effects or foods that are expected to have prebiotic or probiotic effects
11. Persons who have experience with cosmetic treatments on the face
12. Persons with obvious inflammation on the face or skin diseases diagnosed by a doctor
13. Persons who are undergoing hormone replacement therapy
14. Persons who have eyelash extensions
15. Persons who have artificial makeup on the outer corner of the eyes
16. Persons who have participated in other tests within the first month before the start of the test, or those who intend to participate in another exam after consenting to this exam
17. Persons who were judged as inappropriate for study participants by the principal investigator
18. Persons who are pregnant, planning or hoping to be pregnant during the study period, breastfeeding
19. Persons who regularly engage in aerobic exercise such as walking, jogging, or cycling (at least three times a week).
Target Size - 30
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 09 Month 05 Day
Date of IRB - 2025 Year 09 Month 05 Day
Anticipated trial start date - 2025 Year 09 Month 05 Day
Last follow-up date - 2025 Year 12 Month 13 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067483
Disclaimer: Curated by HT Syndication.
