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To assess TCI153 prebiotics product on skin condition improvement
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo sachet | Placebo Comparator | consume 1 sachet per day |
|
| TCI153 sachet | Experimental | consume 1 sachet per day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo sachet | Dietary Supplement | Consume 1 sachet daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The change of skin wrinkles | VISIA Complexion Analysis System was utilized to measure skin wrinkles. Units: arbitrary units | Change from Baseline skin wrinkles at 8 weeks |
| The change of skin texture | VISIA Complexion Analysis System was utilized to measure skin texture. Units: arbitrary units | Change from Baseline skin texture at 8 weeks |
| The change of skin melanin index | Mexameter® MX18 was utilized to measure skin melanin index. Units: arbitrary units | Change from Baseline skin melanin index at 8 weeks |
| The change of skin L* value | Chroma Meter MM500 was utilized to measure skin L* value. Units: arbitrary units, 0-100 | Change from Baseline L* value at 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The change of skin elasticity | Cutometer® MPA580 was utilized to measure skin elasticity. Units: arbitrary units | Change from Baseline skin elasticity at 8 weeks |
| The change of skin erythema index |
| Measure | Description | Time Frame |
|---|---|---|
| The change of liver function biomarkers (AST, ALT) of blood | Fasting venous blood was sampled to measure liver function biomarkers | Change from Baseline liver function biomarkers at 8 weeks |
| The change of renal function biomarkers (creatinine, BUN) of blood |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chia-Hua Liang | Chia Nan University of Pharmacy ＆ Science | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chia Nan University of Pharmacy & Science | Tainan | 71710 | Taiwan |
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| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| ID | Term |
|---|---|
| D017437 | Skin and Connective Tissue Diseases |
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| TCI153 probiotic sachet |
| Dietary Supplement |
Consume 1 sachet daily |
|
|
Mexameter® MX18 was utilized to measure skin erythema index. Units: arbitrary units
| Change from Baseline skin erythema index at 8 weeks |
| The change of skin moisture | Corneometer® CM825 was utilized to measure skin moisture. Units: arbitrary Corneometer® units 0-120 | Change from Baseline skin moisture at 8 weeks |
| The change of transepidermal water loss (TEWL) | Tewameter® TM 210 was utilized to measure TEWL. Units: g/hm² | Change from Baseline TEWL at 8 weeks |
| The change of skin pores | VISIA Complexion Analysis System was utilized to measure skin pores. Units: arbitrary units | Change from Baseline AGEs at 8 weeks |
| The change of gut microbiome composition | Gut microbiome sequencing | Change from Baseline AGEs at 8 weeks |
Fasting venous blood was sampled to measure renal function biomarkers
| Change from Baseline renal function biomarkers at 8 weeks |
| The change of fasting blood glucose | Fasting venous blood was sampled to measure blood glucose | Change from Baseline blood glucose at 8 weeks |
| The change of sialic acid | Fasting venous blood was sampled to measure sialic acid | Change from Baseline sialic acid at 8 weeks |
| The change of Epidermal Growth Factor (EGF) | Fasting venous blood was sampled to measure EGF | Change from Baseline EGF at 8 weeks |