Tokyo, Feb. 6 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060590) titled 'Study on the Effects of Test Food Intake on Skin Function Improvement
- Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Comparative Trial -' on Feb. 5.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - TES Holdings Co., Ltd.
Condition:
Condition - No
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - The purpose of this study is to evaluate the effects of consuming the test food on skin function and to confirm its safety.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Test food A: 2 packets once daily for 8 weeks
Interventions/Control_2 - Test food B: 2 packets once daily for 8 weeks
Eligibility:
Age-lower limit - 35
years-old
Gender - Female
Key inclusion criteria - 1) Women aged 35 or older but under 55 at the time of obtaining consent to participate in the trial.
2) Healthy individuals without chronic physical diseases, including skin diseases.
3) Individuals who notice dryness or aging in their skin.
4) Individuals who have received sufficient explanation regarding the purpose and content of this trial, possess the capacity to consent, voluntarily volunteer to participate after fully understanding, and can provide written consent to participate in this trial.
5) Individuals who can attend the designated examination date and undergo the examination.
6) Individuals deemed suitable for participation in this trial by the principal investigator.
Key exclusion criteria - Individuals
1) currently suffering from any disease and undergoing drug therapy.
2) undergoing hormone replacement therapy.
3) with symptoms of skin diseases such as atopic dermatitis.
4) who have taken or applied drugs for disease treatment within the past month.
5) with a history or current condition of severe disorders affecting the digestive organs, liver, kidneys, heart, lungs, blood, or mental health.
6) with a BMI of 30.0 kg/m2 or higher.
7) who may have allergic reactions to test food components, or severe allergies to other foods or medications.
8) who currently, or within the past 3 months, have regularly consumed foods or supplements claiming skin improvement and containing ingredients that may affect the results.
9) with a habit of consuming natto or green juice.
10) whose average daily alcohol intake exceeds 20 g of pure alcohol per day.
11) with a smoking habit.
12) who may work night shifts or change their lifestyle habits during the trial period.
13) who may experience symptoms such as itching at the evaluation site during the trial period due to seasonal allergies like hay fever. Also, individuals who may take anti-allergy medications or use nasal sprays.
14) who cannot avoid intentional exposure to direct sunlight, such as sunbathing, during the trial period.
15) who have undergone cosmetic procedures or treatments on the evaluation site within the past 6 months, such as aesthetic treatments or hyaluronic acid injections.
16) with wounds or inflammation at the evaluation site, or those who expect test-affecting skin irritation at the site around menstruation.
17) who are pregnant, breastfeeding, or at risk of becoming pregnant during the trial period.
18) currently participating in another human clinical trial, or those who completed another trial within the past 3 months.
19) Other individuals deemed unsuitable for this trial by the principal investigator.
Target Size - 84
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 01 Month 21 Day
Date of IRB - 2026 Year 01 Month 22 Day
Anticipated trial start date - 2026 Year 02 Month 24 Day
Last follow-up date - 2026 Year 04 Month 27 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069157
Disclaimer: Curated by HT Syndication.
