Study for the Effects of a Test Food on Skin Function.
- Conditions
- /A(healthy adults)
- Registration Number
- JPRN-UMIN000046489
- Lead Sponsor
- TES Holdings Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 100
Not provided
[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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method [1]Transepidermal water loss (Screening, Week 0, Week 6, Week 12).
- Secondary Outcome Measures
Name Time Method *Secondary indexes [1]Skin moisture content (Screening, Week 0, Week 6, Week 12). [2]Skin viscoelasticity (Screening, Week 0, Week 6, Week 12). [3]Collagen Score (Screening, Week 0, Week 6, Week 12). [4]Observation for skin condition by dermatologists (Screening, Week 0, Week 6, Week 12). [5]Visual Analogue Scale (Week 0, Week 6, Week 12). *Safety [1]Doctor's questions (Screening, Week 0, Week 6, Week 12). [2]Subject's diary (From the first day of ingestion of a test material to the last day of the test).