The verification study for long-term intake safety and the effect on skin barrier function (moisturizing power) of test food intake; A randomized, placebo-controlled, double-blind, parallel study
- Conditions
- Healthy subjects
- Registration Number
- JPRN-UMIN000050422
- Lead Sponsor
- Pharma Foods International Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 30
Not provided
1. Subjects who have serious current or past diseases such as brain disease, malignant tumor, immune disease, diabetes, renal disease, heart disease, thyroid disease, adrenal disease, and other metabolic diseases 2. Currently undergoing treatment for any of the following chronic diseases: arrhythmia, dyslipidemia, hypertension, and other chronic diseases 3. Subjects with severe skin disease symptoms such as atopy or dermatitis 4. Subjects who cannot intentionally refrain from exposure to direct sunlight, such as sunburn 5. Subjects who are allergic to medications and/or the test food related products 6. Subjects who are pregnant, breast-feeding, or planning to become pregnant 7. Currently, or within the past 2 weeks, subjects who have a habit of continuously taking drugs (pharmaceuticals and quasi-drugs with moisturizing effects, anti-wrinkle effects, etc.) or health foods that claim to have skin-improving effects, or subjects who have a habit of applying the above drugs on their arms 8. Subjects who are judged to be unsuitable as subjects based on clinical test values and skin test values at the time of screening 9. Subjects who are judged as ineligible to participate in the study by the physician
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method (Effectiveness evaluation) 1. Transepidermal Water Loss (TEWL) * Assess these tests at screening (before consumption) and at 4, 8 and 12 weeks after consumption.
- Secondary Outcome Measures
Name Time Method (Safety evaluation) 1.Physical measurement 2.Vital signs(Blood pressure/pulse) 3.Blood biochemistry 4.Blood hematology 5.Urinalysis 6.Adverse events * Assess these tests at screening (before consumption) and at 4, 8 and 12 weeks after consumption and 4 weeks after consumption completed. (Effectiveness evaluation) 1.Moisture of the skin surface 2.Visual Analogue Scale (VAS) of itching sensation 3.The Japanese version of Skindex-29 * Assess these tests at screening (before consumption) and at 4, 8 and 12 weeks after consumption.