Efficacy Testing of Collagen and Zhuyin Drinks

Study Overview
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Brief Summary
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To assess collagen and zhuyin drink on skin & body condition improvement

Official Title
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Efficacy Testing of Collagen and Zhuyin Drinks

Conditions
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Skin Condition

Intervention / Treatment
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* Dietary Supplement: Placebo drink
* Dietary Supplement: Collagen Cubilose Drink


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy adults aged above 20 years old Exclusion Criteria: Subject who is not willing to participate in this study. Patients with diseases of the skin, heart, liver, kidney, endocrine and other organs and patients with mental illness (according to medical history). 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 in the past 4 weeks. Vegetarian Subjects who have large spots (area >3 square centimeter) or abnormal acne.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo drink<br> | Dietary Supplement: Placebo drink<br>* consume 1 bottle (50 mL) per day for 28 days<br>|
| Experimental: Collagen and Zhuyin Drinks<br> | Dietary Supplement: Collagen Cubilose Drink<br>* consume 1 bottle (50 mL) per day for 28 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 4 weeks | 
| The change of skin wrinkles | VISIA Complexion Analysis System was utilized to measure wrinkles. Units: arbitrary units | Change from Baseline skin wrinkles at 4 weeks | 
| The change of skin collagen density | DermaLab® USB - 20 MHz High Freq. Ultrasound probe was utilized to scan and analyze skin collagen density. Units:Intensity score | Change from Baseline skin collagen density at 4 weeks | 
| The change of TEWL | Tewameter® TM 300 was utilized to measure TEWL. Units: g/h/m2 | Change from Baseline TEWL at 4 weeks | 
| The change of skin brightness | Glossymeter GL 200 was utilized to measure skin brightness. Units: arbitrary units | Change from Baseline skin brightness at 4 weeks | 
| The change of interleukin-6 | Venous blood was sampled to measure concentrations of interleukin-6. | Change from Baseline skin brightness at 4 weeks | 
| The change of interleukin-8 | Venous blood was sampled to measure concentrations of interleukin-8. | Change from Baseline skin brightness at 4 weeks | 
| The change of Tumor necrosis factor | Venous blood was sampled to measure concentrations of Tumor necrosis factor. | Change from Baseline skin brightness at 4 weeks | 
| The change of Matrix metalloproteinase-1 | Venous blood was sampled to measure concentrations of Matrix metalloproteinase-1 . | Change from Baseline skin brightness at 4 weeks | 
| The change of metallopeptidase inhibitor 1 | Venous blood was sampled to measure concentrations of metallopeptidase inhibitor 1. | Change from Baseline skin brightness at 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of skin texture | VISIA Complexion Analysis System was utilized to measure skin texture. Units: arbitrary units | Change from Baseline skin texture at 4 weeks | 
| The change of skin pores | VISIA Complexion Analysis System was utilized to measure skin pores. Units: arbitrary units | Change from Baseline skin pores at 4 weeks | 
| The change of skin spots | VISIA Complexion Analysis System was utilized to measure skin spots. Units: arbitrary units | Change from Baseline skin spots at 4 weeks | 
| The change of red areas | VISIA Complexion Analysis System was utilized to measure red areas. Units: arbitrary units | Change from Baseline red areas at 4 weeks |