Effects of a Test Food for Improvement of Skin Functio
- Conditions
- o
- Registration Number
- JPRN-UMIN000050245
- 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
- 15
Not provided
[1] Individuals using medical products. [2] Individuals with skin disease symptoms such as atopic dermatitis. [3] Individuals who have wounds or inflammation in the evaluation site and have experience of aesthetic medicine. [4] Individuals who received aesthetic medicine other than the measurement site or hormone replacement therapy within one year before the preliminary examination. [5] Individuals who used a drug to treat a disease in the past 1 month. [6] Individuals who have a history of serious hepatopathy, kidney damage, heart disease, hematological and blood disease. [7] Individuals who contract or have a history of serious gastrointestinal disease. [8] Individuals with anemia. [9] Individuals whose BMI is over 30 kg/m2. [10] Individuals with irregular bowel habits (constipation, loose stools, and diarrhea). [11] Individuals who currently or within the past 3 months have a habit of taking foods for specified health uses, foods with function claims, health foods, and supplements, or plan to take them during the test period. [12] Individuals who use cosmetics that have strong moisturizing effects, wrinkles, and whitening effects (such as serum sealer patches). [13] Individuals who are or are possibly pregnant, or are lactating. [14] Individuals who excessively take alcohol (expressed in an amount of alcohol: over 30g/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 are likely to develop seasonal or perennial allergic symptoms during the study period and who may use pharmaceuticals (eye drops and nasal drops are acceptable). [19] Individuals who neglect skin care. [20] Individuals who participated in other clinical studies in the past 3 months. [21]Individuals judged inappropriate for the study by the principal.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method *Skin measurements [1] Skin moisture content (Week 0, Week 2, Week 4) [2] Transepidermal water loss (Week 0, Week 4) [3] Colour difference (Week 0, Week 4) [4] Image analysis by VISIA (Week 0, Week 2, Week 4) [5] Collagen Score (Week 0, Week 4) [6] Observation for skin condition by dermatologists (Week 0, Week 2, Week 4)
- Secondary Outcome Measures
Name Time Method [1] Capillary evaluation by capillary scope (Week 0, Week 4) [2] Visual Analogue Scale(Week 0, Week 2, Week 4) [3] Questionnaires at the end of the study (Week 4) *Safety [1] Blood pressure, pulsation (Week 0, Week 2, Week 4) [2] Doctor's questions (Week 0, Week 2, Week 4) [3] Adverse events: number of cases and expression rate of adverse events (Week 2, Week 4) [4] Subject's diary (From the first day of ingestion of a test material to the last day of the test)