Skin Condition
Conditions
Brief summary
To assess TCI153 prebiotics product on skin condition improvement
Interventions
DIETARY_SUPPLEMENTPlacebo sachet
Consume 1 sachet daily
DIETARY_SUPPLEMENTTCI153 probiotic sachet
Consume 1 sachet daily
Sponsors
TCI Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Healthy adults aged above 18 years old
Exclusion criteria
* Subject who is not willing to participate in this study. * Patients with diseases of the skin, liver, kidney. * Subjects who have known cosmetic, drug or food allergies, difficulty in digestive tract absorption or disorder. * Female who is pregnant or nursing or planning to become pregnant during the course of the study. * Received facial laser therapy, chemical peeling or UV overexposure (\> 3 hr/week) in the past 4 weeks. * Constant drug use * Students who are currently taking courses taught by the principal investigator of this trial. * Subject who is not willing to have their photos published in public.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The change of skin wrinkles | Change from Baseline skin wrinkles at 8 weeks | VISIA Complexion Analysis System was utilized to measure skin wrinkles. Units: arbitrary units |
| The change of skin texture | Change from Baseline skin texture at 8 weeks | VISIA Complexion Analysis System was utilized to measure skin texture. Units: arbitrary units |
| The change of skin melanin index | Change from Baseline skin melanin index at 8 weeks | Mexameter® MX18 was utilized to measure skin melanin index. Units: arbitrary units |
| The change of skin L* value | Change from Baseline L* value at 8 weeks | Chroma Meter MM500 was utilized to measure skin L\* value. Units: arbitrary units, 0-100 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The change of skin pores | Change from Baseline AGEs at 8 weeks | VISIA Complexion Analysis System was utilized to measure skin pores. Units: arbitrary units |
| The change of gut microbiome composition | Change from Baseline AGEs at 8 weeks | Gut microbiome sequencing |
| The change of skin elasticity | Change from Baseline skin elasticity at 8 weeks | Cutometer® MPA580 was utilized to measure skin elasticity. Units: arbitrary units |
| The change of skin erythema index | Change from Baseline skin erythema index at 8 weeks | Mexameter® MX18 was utilized to measure skin erythema index. Units: arbitrary units |
| The change of skin moisture | Change from Baseline skin moisture at 8 weeks | Corneometer® CM825 was utilized to measure skin moisture. Units: arbitrary Corneometer® units 0-120 |
| The change of transepidermal water loss (TEWL) | Change from Baseline TEWL at 8 weeks | Tewameter® TM 210 was utilized to measure TEWL. Units: g/hm² |
Other
| Measure | Time frame | Description |
|---|---|---|
| The change of liver function biomarkers (AST, ALT) of blood | Change from Baseline liver function biomarkers at 8 weeks | Fasting venous blood was sampled to measure liver function biomarkers |
| The change of renal function biomarkers (creatinine, BUN) of blood | Change from Baseline renal function biomarkers at 8 weeks | Fasting venous blood was sampled to measure renal function biomarkers |
| The change of fasting blood glucose | Change from Baseline blood glucose at 8 weeks | Fasting venous blood was sampled to measure blood glucose |
| The change of sialic acid | Change from Baseline sialic acid at 8 weeks | Fasting venous blood was sampled to measure sialic acid |
| The change of Epidermal Growth Factor (EGF) | Change from Baseline EGF at 8 weeks | Fasting venous blood was sampled to measure EGF |
Countries
Taiwan
Outcome results
None listed