Tokyo, May 8 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061470) titled 'Research on the effects of black tea polyphenols on the skin' on May 7.
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 when black tea is ingested continuously for 8 weeks by adult women aged 30 to 49.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Ingest 1,050 mL of the test food (black tea) once a day, daily for 8 weeks.
Eligibility:
Age-lower limit - 30
years-old
Gender - Female
Key inclusion criteria - 1) Persons who received a sufficient explanation of the purpose and contents of the study, have the capacity to consent, applied with free will with sufficient understanding, and agreed to participate.
2) Japanese females who are 30 years old or more and under 50 years old at the time of informed consent.
3) Persons who have concerns about their skin.
Key exclusion criteria - 1) Persons who have chronic illness, receiving medication, or have a serious disease history.
2) Persons who are allergic to the test food.
3) Persons who usually take a large amount of black tea (3 cups or more per day).
4) Persons who usually take medicine, health foods (specified health foods, functional foods, and functional nutrition foods), or other supplements expected to have cosmetic effects.
5) Persons who have experienced cosmetic medicine on the face.
6) Persons who have inflammation or skin disease on the face.
7) Persons receiving hormone replacement therapy.
8) Persons with eyelash extensions.
9) Persons with permanent makeup on the corners of the eyes.
10) Persons whose measurement date may overlap with their menstrual period.
11) Persons who may develop seasonal allergic symptoms such as hay fever and may use medications during the study period.
12) Persons who have participated in other studies within one month before the start of the study, or who plan to participate in another study after consenting to this study.
13) Persons who were judged as inappropriate for study participants by the principal investigator or the research director.
14) Persons who are pregnant, planning or hoping to be pregnant during the study period, or breastfeeding.
Target Size - 15
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 04 Month 24 Day
Date of IRB - 2026 Year 04 Month 24 Day
Anticipated trial start date - 2026 Year 05 Month 16 Day
Last follow-up date - 2026 Year 08 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070342
Disclaimer: Curated by HT Syndication.
