Tokyo, Dec. 12 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060051) titled 'Verification Study on the Effects of Test Food Intake on Skin
- Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Comparative Trial -' on Dec. 11.
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 - Oral intake of the test food (1 bottle in a day; 8 weeks)
Interventions/Control_2 - Oral intake of the placebo food (1 bottle in a day; 8 weeks)
Eligibility:
Age-lower limit - 35
years-old
Gender - Male and Female
Key inclusion criteria - 1) Men and women aged 35 years or older but under 65 years at the time of obtaining consent to participate in the trial.
2) Healthy individuals without chronic physical diseases, including skin diseases.
3) Individuals who perceive their skin as dry.
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 treatment.
2) undergoing hormone replacement therapy.
3) with skin disease symptoms such as atopic dermatitis.
4) who have taken or applied medication for disease treatment within the past month.
5) with a history or current condition of serious 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) at risk of allergic reactions to components in the test food, or individuals at risk of severe allergic reactions to other foods or pharmaceuticals.
8) with a habit of excessive consumption of soy products such as tofu, natto, or soy milk.
9) with a current or recent (within 3 months) habit of regularly consuming FOSHU, functional foods, or health foods claiming benefits for skin, sleep, stress, or intestinal health.
10) whose average weekly alcohol consumption exceeds 40 g/day for men and 20 g/day for women, calculated as pure alcohol.
11) with smoking habits.
12) who may change their night work schedule or lifestyle habits during the trial period.
13) at risk of itching or other symptoms on evaluation sites during the trial due to seasonal allergies, and those who may use anti-allergy medications or nasal sprays.
14) unable to avoid intentional exposure to direct sunlight, such as sunbathing, during the trial period.
15) with a daily habit of using beauty devices such as facial beauty devices.
16) who have undergone cosmetic procedures or treatments on the evaluation site within the past 6 months, such as esthetic treatments or hyaluronic acid injections.
17) who are pregnant, breastfeeding, or who may become pregnant during the trial period.
18) currently participating in another human clinical trial, or individuals who have not completed 3 months since participating in another human clinical trial.
19) Other individuals deemed unsuitable for this trial by the principal investigator.
Target Size - 70
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 11 Month 18 Day
Date of IRB - 2025 Year 11 Month 19 Day
Anticipated trial start date - 2026 Year 01 Month 10 Day
Last follow-up date - 2026 Year 04 Month 02 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068427
Disclaimer: Curated by HT Syndication.
