No(Healthy adults)
Conditions
Interventions
Oral intake of the test product A (10 capsules in a day
8 weeks).
Oral intake of the test product B (10 capsules in a day
8 weeks).
Oral intake of the placebo product (10 capsules in a day
8 weeks).
Sponsors
TES Holdings Co., Ltd.
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: [1] Healthy Japanese females aged 40-64 years. [2] Individuals who are healthy and have no chronic physical disease including skin disease. [3] Individuals who are aware of skin dryness. [4] Individuals whose written informed consent has been obtained after explanation of this study. [5] Individuals who can have an examination on a designated check day [6] Individuals judged appropriate for the study by the principal.
Exclusion criteria
Exclusion criteria: [1] Individuals using medical products. [2] Individuals with strange skin conditions at measurement points. [3] Individuals with strange skin conditions at measurement points. [4] Individuals who used a drug to treat a disease in the past 1 month. [5] Individuals who have a history of serious hepatopathy, kidney damage, heart disease, hematological and blood disease. [6] Individuals who contract or have a history of serious gastrointestinal disease. [7] Individuals with serious anemia. [8] Individuals whose BMI is over 30 kg/m2. [9] Individuals who are sensitive to test product or other foods, and medical products. [10]Individuals who have a habit to ingest or use health-promoting foods, or supplements containing similar composition with a test food in the past 3 months or will ingest those foods during the test period. [11] Individuals who are or are possibly pregnant, or are lactating. [12] Individuals who excessively take alcohol. [13] Individuals who are patient or have a history of psychiatric disease. [14] Individuals who are a smoker. [15] Individuals who work in sales or delivery, and who engage in outdoor activities and are exposed UV radiation in their daily lives. [16] Individuals with possible changes of life style during the test period. [17] Individuals who will develop seasonal allergy symptoms like hay fever and use a drug. [18] Individuals who neglect skin care. [19] Individuals who will get sunburned during the test period. [20] Individuals who had been conducted an operation or beauty treatment on the test spot in the past 6 months. [21] Individuals who participated in other clinical studies in the past 3 months. [22] Individuals judged inappropriate for the study by the principal.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Indexes for skin function. [1]Transepidermal water loss (Week 0, Week 8). [2]Skin moisture content (Week 0, Week 8). | — |
Secondary
| Measure | Time frame |
|---|---|
| *Secondary indexes [1] Skin viscoelasticity (Week 0, Week 8). [2] Observation for skin condition by dermatologists (Week 0, Week 8). [3] Skin Age measurement (Week 0, Week 8). [4] Plasma pentosidine (Week 0, Week 8). [5] Visual Analogue Scale (Week 0, Week 4, Week 8). *Safety [1] Blood pressure, pulsation (Week 0, Week 8). [2] Weight, body fat percentage, BMI (Week 0, Week 8). [3] Blood test (Week 0, Week 8). [4] Blood biochemical test (Week 0, Week 8). [5] Urine analysis (Week 0, Week 8). [6] Doctor's questions (Week 0, Week 8). [7] Adverse events: number of cases and expression rate of adverse events (Week 8). [8] Subject's diary (From the first day of ingestion of a test material to the last day of the test). | — |
Countries
Japan
Contacts
Public ContactRyoma Shimizu
TES Holdings Co., Ltd. Administrative Department of Clinical Trials
Outcome results
None listed