Testing the Cognitive Facilitation Effect by Dietary Supplementation of MelaGene+ Drink

Study Overview
=================
Brief Summary
-----------------
To assess the efficacy of MelaGene+ on cognitive performance

Official Title
-----------------
Testing the Cognitive Facilitation Effect by Dietary Supplementation of MelaGene+ Drink

Conditions
-----------------
Cognitive Change

Intervention / Treatment
-----------------
* Dietary Supplement: placebo
* Dietary Supplement: MelaGene+


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 20 to 65-year-old males or females Exclusion Criteria: Participants are breastfeeding, pregnant or planning to become pregnant during the test (self-report) Participants with heart, liver, kidney, endocrine and other major organic diseases (self-reported) Participants take drugs for a long time (self-report) Participants with mental illness or have undergone brain surgery Participants still can not clearly see words with 12pt on computer after corrected vision

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

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

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<br>* consume one bottle (30 mL) per day<br>|
| Experimental: MelaGene+<br> | Dietary Supplement: MelaGene+<br>* consume one bottle (30 mL) per day<br>* Other names: Melaleuca-MelaGene+;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of Match to sample test | The number of memorized cards was utilized to measure Match to sample test value. | Change from Baseline match to sample test value at 8 weeks | 
| The change of Trail making test | The time of finishing actions was utilized to measure Trail making test value. | Change from Baseline Trail making test value at 8 weeks | 
| The change of Processing speed test | The number of pressing buttons was utilized to measure Processing speed test value. | Change from Baseline Processing speed test value at 8 weeks | 
| The change of Mnemonic Similarity Task | The proportion of correction about ability on memorizing old things was utilized to measure Mnemonic Similarity Task value. | Change from Baseline Mnemonic Similarity Task value at 8 weeks | 
| The change of facial expression cuing task | The correction of evaluation on facial emotion was utilized to measure facial expression cuing task value. | Change from Baseline facial expression cuing task value at 8 weeks | 
| The change of State-trait anxiety inventory | The scores of anxiety state was utilized to measure State-trait anxiety inventory value. | Change from Baseline State-trait anxiety inventory value at 8 weeks | 
| The change of score of fatigue | The PSS (The Perceived Stress Scale)-14 questionnaire was utilized to measure fatigue condition. | Change from Baseline PSS (The Perceived Stress Scale)-14 value at 8 weeks | 
| The change of score of life quality | The WHOQOL-BREF (The World Health Organization Quality of Life Brief Version) questionnaire was utilized to measure life quality. | Change from Baseline WHOQOL-BREF (The World Health Organization Quality of Life Brief Version) value at 8 weeks |