Efficacy and Safety of Fermented Velvet Antler Extract on Fatigue Recovery After Exercise

Study Overview
=================
Brief Summary
-----------------
The investigators performed a 12-week, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of Fermented Velvet Antler extract on fatigue recovery after exercise. The investigators measured fatigue recovery parameters , including lactate, ammonia, inorganic phosphorus, creatine kinase and LDH, and monitored their blood pressure.

Conditions
-----------------
Chronic Fatigue Syndrome

Intervention / Treatment
-----------------
* Dietary Supplement: Fermented Velvet Antler extract
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males and females 19-60 years old Hemoglobin concentration between 13 and 14 g/dL(men), 12 and 13 g/dL(women) Able to give informed consent Exclusion Criteria: Allergic or hypersensitive to any of the ingredients in the test products History of reaction to any of the test products or of gastrointestinal diseases such as Crohn's disease or gastrointestinal surgery Participation in any other clinical trials within past 2 months Laboratory test, medical or psychological conditions deemed by the investigators to interfere with successful participation in the study Pregnant or lactating women etc.

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 60 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fermented Velvet Antler extract<br> | Dietary Supplement: Fermented Velvet Antler extract<br>* Fermented Velvet Antler extract (1g/day)<br>|
| Placebo Comparator: Placebo<br> | Dietary Supplement: Placebo<br>* Placebo (1g/day)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in lactate | Lactate was measured in study visit 1(0 week) and visit 3(12 week). | 12 weeks | 
| Changes in ammonia | Ammonia was measured in study visit 1(0 week) and visit 3(12 week). | 12 weeks | 
| Changes in inorganic phosphorus | Inorganic phosphorus was measured in study visit 1(0 week) and visit 3(12 week). | 12 weeks | 
| Changes in creatine kinase | Creatine kinase was measured in study visit 1(0 week) and visit 3(12 week). | 12 weeks | 
| Changes in Lactage dehydrogenase(LDH) | Lactage dehydrogenase(LDH) was measured in study visit 1(0 week) and visit 3(12 week). | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Multidimensional Fatigue Scale(MFS) | Multidimensional Fatigue Scale(MFS) was measured in study visit 1(0 week) and visit 3(12 week). | 12 weeks | 
| Changes in 36-Item Short-Form Health Survey(SF-36) | 36-Item Short-Form Health Survey(SF-36) was measured in study visit 1(0 week) and visit 3(12 week). | 12 weeks |