None listed
Conditions
Interventions
Test food A: 2 packets once daily for 8 weeks
Test food B: 2 packets once daily for 8 weeks
Placebo food: 2 packets once daily for 8 weeks
Sponsors
TES Holdings Co., Ltd.
Eligibility
Sex/Gender
Female
Inclusion criteria
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.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Skin moisture-related indicators at the 8-week post-intervention examination | — |
Secondary
| Measure | Time frame |
|---|---|
| *Secondary Evaluation Items 1) Skin-related indicators at the 8-week post-intervention examination a. Skin viscoelasticity b. Collagen score c. VISIA facial image analysis d. Visual assessment by a specialist physician e. Perceived VAS questionnaire *Safety Evaluation Items 1) Physical Examination (Blood Pressure/Pulse Rate, Weight/Body Fat Percentage/BMI) 2) Daily Activity Log 3) Physician Consultation and Adverse Event Investigation *Other Items 1) The Fitzpatrick Skin-Type | — |
Countries
Japan
Contacts
Public ContactRyoma Shimizu
TES Holdings Co., Ltd. Administrative Department of Clinical Trials
Outcome results
None listed