Efficacy Evaluation of Pitaya Ovule Extract on Skin

Study Overview
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Brief Summary
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To assess the efficacy of Pitaya Ovule Extract on skin

Official Title
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Efficacy Evaluation of Pitaya Ovule Extract on Skin

Conditions
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Skin Condition

Intervention / Treatment
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* Dietary Supplement: Placebo drink
* Dietary Supplement: Pitaya Ovule Extract Drink


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 20 to 65-year-old males or females Exclusion Criteria: Received medical cosmetic treatment (including cosmetic skin care, laser, fruit acid peeling, injection or plastic surgery, etc.) currently or within one month before the trial Outdoor workers (exposed to the sun more than 5 hours a day) People who are breastfeeding, pregnant or planning to become pregnant during the test (self-report) People with heart, liver, kidney, endocrine and other major organic diseases (self-reported) People who have undergone major surgery (according to medical history) People who take drugs for a long time People with mental illness Students who are currently taking courses taught by the principal investigator of this trial

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo drink<br> | Dietary Supplement: Placebo drink<br>* consume 1 bottle per day<br>|
| Experimental: Pitaya Ovule Extract Drink<br> | Dietary Supplement: Pitaya Ovule Extract Drink<br>* consume 1 bottle per day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of L* (lightness) values | Spectrophotometer SCM-108 was utilized to measure skin L* value. Units: arbitrary units | Change from Baseline L* value at 8 weeks | 
| The change of skin elasticity | Cutometer® Dual MPA580 was utilized to measure skin elasticity. Units: arbitrary units | Change from Baseline skin elasticity at 8 weeks | 
| The change of skin collagen density | DermaLab® Combo Ultrasound module was utilized to measure skin collagen density. Units: arbitrary units | Change from Baseline skin collagen density at 8 weeks | 
| The change of skin wrinkles | IRV skin analyzer was utilized to measure skin wrinkles. Units: arbitrary units | Change from Baseline skin wrinkles at 8 weeks | 
| The change of skin texture | IRV skin analyzer was utilized to measure skin texture. Units: arbitrary units | Change from Baseline skin texture at 8 weeks | 
| The change of skin pores | IRV skin analyzer was utilized to measure skin pores. Units: arbitrary units | Change from Baseline skin pores at 8 weeks | 
| The change of skin tone | IRV skin analyzer was utilized to measure skin tone. Units: arbitrary units | Change from Baseline skin tone at 8 weeks | 
| The change of Advanced glycation end products of blood | Venous blood was sampled to measure AGEs | Change from Baseline AGEs at 8 weeks | 
| The change of RAGE (receptor for advanced glycation end products) of blood | Venous blood was sampled to measure RAGE | Change from Baseline RAGE at 8 weeks | 
| The change of Matrix metalloproteinases (MMP-2, MMP-9) of blood | Venous blood was sampled to measure MMPs | Change from Baseline MMPs at 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of liver function biomarkers (AST, ALT) of blood | 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 | Venous blood was sampled to measure renal function biomarkers | Change from Baseline renal function biomarkers at 8 weeks | 
| The change of fasting blood glucose level | Venous blood was sampled to measure fasting blood glucose level | Change from Baseline fasting blood glucose level at 8 weeks | 
| Change from Baseline insulin level at 8 weeks | Venous blood was sampled to measure insulin level | Change from Baseline insulin level at 8 weeks | 
| The change of blood lipid profile | Venous blood was sampled to measure blood lipid profile (total cholesterol, HDL-C, LDL-C, triglyceride) | Change from Baseline blood lipid profile at 8 weeks |