Omegia Softgel Clinical Research Program

Study Overview
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Brief Summary
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Evaluate the improvement of regulation of skin and blood index composition after consumption of Omegia® Softgel

Detailed Description
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The blood biochemical analysis at Weeks 0 and 12, including Catalase, Tumor necrosis factor-α, Cholesterol, Triglyceride, High-density lipoprotein-Cholesterol and Low-density lipoprotein- Cholesterol. The Skin assessment at Weeks 0, 4 and 12, including Skin brightness, Skin redness sensitivity index, Skin moisture, Skin elasticity, Facial skin pores, Facial skin texture and Skin collagen content.

Official Title
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Chia Nan University of Pharmacy & Science

Conditions
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Skin Manifestations, Antioxidative Stress, Eye Strain, Vaginal Disease

Intervention / Treatment
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* Dietary Supplement: Omegia® Softgel -B
* Dietary Supplement: Omegia® Softgel -A


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ● Female subjects older than 45 years Exclusion Criteria: Involuntary subjects Skin disease, liver cirrhosis or chronic renal failure Those with known cosmetic, drug or food allergies Pregnant women and nursing mothers. Those taking chronic disease medication The subject has received laser facial treatment, fruit acid facial peeling, long-term sunlight, etc. within four weeks of the test

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Omegia® Softgel -A<br>Take Omegia® Softgel -A once a day for 12 weeks | Dietary Supplement: Omegia® Softgel -A<br>* How to use: Take once a day for 12 weeks Subject precautions: If the health products and cosmetic care products used contain sea buckthorn ingredients, stop using them.<br>|
| Experimental: Omegia® Softgel -B<br>Take Omegia® Softgel-B once a day for 12 weeks | Dietary Supplement: Omegia® Softgel -B<br>* How to use: Take once a day for 12 weeks Subject precautions: If the health products and cosmetic care products used contain sea buckthorn ingredients, stop using them.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skin brightness | Skin color difference analyzer (Chroma Meter MM500) was utilized to measure skin brightness. Units: arbitrary units | Subjects will be tested in the 4th week | 
| Skin redness | Skin color difference analyzer (Chroma Meter MM500) was utilized to measure skin redness. Units: arbitrary units | Subjects will be tested in the 4th week | 
| Skin moisture | Skin moisture meter (Corneometer CM825) was utilized to measure skin moisture. Units: arbitrary units | Subjects will be tested in the 4th week | 
| Skin elasticity | Skin elastometer (Soft Plus) was utilized to measure skin elasticity. Units: arbitrary units | Subjects will be tested in the 4th week | 
| Facial skin pores | VISIA Micro-Analysis Skin Image Analyzer was utilized to measure skin pores. Units: arbitrary units | Subjects will be tested in the 4th week | 
| Facial skin texture | VISIA Micro-Analysis Skin Image Analyzer was utilized to measure skin texture. Units: arbitrary units | Subjects will be tested in the 4th week | 
| Skin collagen content | Subcutaneous collagen scanner (DermaLab® Series SkinLab Combo) was utilized to measure skin collagen. Units: arbitrary units | Subjects will be tested in the 4th week |