N/A(healthy adults)
Conditions
Interventions
12 weeks).
Oral intake of the placebo (1 capsule / day
12 weeks).
Sponsors
TES Holdings Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: [1]Healthy Japanese males and females aged 30-59 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 skin disease, such as atopic dermatitis. [3]Individuals with strange skin conditions at measurement points. [4]Individuals who used a drug to treat a disease in the past 1 month (except temporal usage for pollenosis). [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 had a habit to ingest 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 have a habit to ingest 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. [12]Individuals who have a habit to use drug claiming to improve skin condition in the past 3 months. [13]Individuals who are or are possibly pregnant, or are lactating. [14]Individuals who excessively take alcohol (expressed in an amount of alcohol: over 60mg/day). [15]Individuals who are patient or have a history of psychiatric disease. [16]Individuals who are a smoker. [17]Individuals with possible changes of life style during the test period. [18]Individuals who will develop seasonal allergy symptoms like hay fever and use a drug. [19]individuals who neglect skin care. [20]Individuals who will get sunburned during the test period. [21]Individuals who had been conducted an operation or beauty treatment on the test spot. [22]Individuals who participated in other clinical studies in the past 3 months. [23]Individuals judged inappropriate for the study by the principal.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| [1]Transepidermal water loss (Screening, Week 0, Week 4, Week 8, Week 12). | — |
Secondary
| Measure | Time frame |
|---|---|
| *Secondary indexes [1]Skin moisture content (Screening, Week 0, Week 4, Week 8, Week 12). [2]Skin viscoelasticity (Screening, Week 0, Week 4, Week 8, Week 12). [3]Observation for skin condition by dermatologists (Screening, Week 0, Week 4, Week 8, Week 12). [4]Visual Analogue Scale (Screening, Week 0, Week 4, Week 8, Week 12) *Safety [1]Blood pressure, pulsation (Screening, Week 0, Week 4, Week 8, Week 12). [2]Weight, body fat percentage, BMI (Week 0, Week 4, Week 8, Week 12). [3]Blood test (Week 0, Week 4, Week 8, Week 12). [4]Blood biochemical test (Week 0, Week 4, Week 8, Week 12). [5]Urine analysis (Week 0, Week 4, Week 8, Week 12). [6]Doctor's questions (Screening, Week 0, Week 4, Week 8, Week 12). [7]Adverse events: number of cases and expression rate of adverse events (Week 4, Week 8, Week 12). [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