Anti-aging and Anti-oxidant Efficacy Evaluation of the MelaGene

Study Overview
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Brief Summary
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The primary purpose of the present study is to evaluate the effects of MelaGene on anti-aging and anti-oxidant.

Official Title
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Anti-aging and Anti-oxidant Efficacy Evaluation of the MelaGene

Conditions
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Aging, Antioxidative Stress

Intervention / Treatment
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* Dietary Supplement: Placebo drink
* Dietary Supplement: MelaGene drink


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 30 to 65-year-old; Must read and sign the informed consent form before the experiment; People who are willing to cooperate with contraception during the trial period; Do not change lifestyle and eating habits arbitrarily during the trial period; Do not take supplementary foods and health supplements with the same efficacy two weeks before and during the test; If any adverse reaction occurs during the experiment, subjects should be notified the researcher immediately. Exclusion Criteria: Subject who is not willing to participate in this study; Vegetarians; People with a history of organ transplantation, epilepsy or convulsions, liver and kidney disease, malignant tumors, endocrine diseases, mental illness, alcohol or drug abuse, and other major organic diseases (according to medical history); Participate in other clinical trials related to antioxidants and anti-aging four weeks before and during the test; People with a history of dyspepsia would affect the absorption of the test product; Allergic to the components of the test product; Pregnant or breast-feeding women; Take anti-oxidant supplements; Undergoing hormone replacement therapy.

Ages Eligible for Study
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Minimum Age: 30 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: Treatment
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 for 8 weeks<br>|
| Experimental: MelaGene drink<br> | Dietary Supplement: MelaGene drink<br>* consume 1 bottle per day for 8 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of blood lipid (Triglyceride, total cholestrol, HDL-C, LDL-C) | Venous blood is sampled to measure concentrations of blood lipid (Triglyceride, total cholestrol, HDL-C, LDL-C) | Days 1, 28, and 56 | 
| The change of ALT and AST | Venous blood is sampled to measure concentrations of ALT and AST | Days 1, 28, and 56 | 
| The change of MDA | Venous blood is sampled to measure concentrations of MDA | Days 1, 28, and 56 | 
| The change of blood antioxidants(f-Thiols, t-GSH, GST-RBC, SOD, Total Anit-oxidative Capicity) | Venous blood is sampled to measure concentrations of blood antioxidants(f-Thiols, t-GSH, GST-RBC, SOD, Total Anit-oxidative Capicity) | Days 1, 28, and 56 | 
| The change of anti-aging gene expression | Venous blood is sampled to measure expression of anti-aging gene | Days 1, 28, and 56 | 
| The change of cardiovascular endurance | Step test is designed to assess cardiovascular endurance | Days 1, 28, and 56 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of continuous attention test | Continuous attention test is designed to assess cognitive performance | Days 1, 28, and 56 | 
| The change of fatigue condition | BFI-Taiwan Form is collected to assess fatigue condition | Days 1, 28, and 56 |