A Clinical Trial of Bio-Germanium for the Evaluation of Efficacy on Immune Function

Study Overview
=================
Brief Summary
-----------------
This study is a 8-week, randomized, double-blind, placebo-controlled clinical trial of Bio-Germanium for the evaluation of efficacy on immune function and immune cell activation.

Detailed Description
-----------------
This study will evaluate Bio-Germanium's efficacy on immune function and immune cell activation in healthy volunteers by assessing improvements in certain immune indices (i.e. NK cell activity, WBC, IFN-γ, TNF-α, IgG1, IgG2, IgM, IL-2, 6, 12).

Official Title
-----------------
A Clinical Trial of Bio-Germanium for the Evaluation of Efficacy on Immune Function Enhancement and Immune Cell Activation

Conditions
-----------------
Normal Healthy Subjects

Intervention / Treatment
-----------------
* Dietary Supplement: Investigational Product (Bio-Germanium)
* Dietary Supplement: Control Group - Placebo Product


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male and female volunteers between the ages of 25 to 75 years Screening result for WBC counts in between 4,000 cells/ul and 8,000 cells/ul Volunteers who have agreed to participate in the study and provided a written content by him/herself or through its legal representative Exclusion Criteria: Those under the treatment for clinically significant acute or chronic diseases in cardiovascular, immune, respiratory, liver, biliary, renal, urinary, nervous, musculoskeletal system as well as psychiatric, infectious, hematologic and neoplastic diseases (exceptions can be made under the discretion of the researcher) Those with uncontrolled hypertension (140/90mmHg or higher, measured after 10 minutes of resting) Those with uncontrolled diabetes (fasting blood glucose levels greater than 126mg/dl or those starting diabetes medication within 3 months) Those received vaccination within 3 months before screening Those with blood AST(GOT) or ALT(GPT) levels greater than 120IU/L Those with blood creatinine level greater than 2.4mg/dL for male and 1.8mg/dL for female Those who have consumed within 2 weeks before screening or are currently consuming health supplements that can affect immune function Those under the severe gastrointestinal symptoms such as heartburn, indigestion, and such Those who are pregnant, breastfeeding or planning to become pregnant during this study Those who are oversensitive or allergic to the investigational product Those who plan to participate in other researches during this study Those who participated in other researches within 4 weeks of the start of this study Those who are deemed inappropriate by the researcher

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 75 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Investigational Group- Bio-Germanium<br>Ingredient: Bio-Germanium Type: HPMC capsule Weight: 300mg/capsule Directions: 2 capsules, twice a day (1.2g/day of Bio-Germanium) Duration of use: 8 weeks | Dietary Supplement: Investigational Product (Bio-Germanium)<br>* Ingredient: Bio-Germanium Type: HPMC capsule Weight: 300mg/capsule Directions: 2 capsules, twice a day (1.2g/day of Bio-Germanium) Storage: Room temperature (below 25℃) Duration of use: 8 weeks<br>|
| Placebo Comparator: Control Group - Placebo Product<br>Ingredient: Corn starch Type: HPMC capsule Weight: 300mg/capsule Directions: 2 capsules, twice a day Duration of use: 8 weeks | Dietary Supplement: Control Group - Placebo Product<br>* Ingredient: Corn starch Type: HPMC capsule Weight: 300mg/capsule Directions: 2 capsules, twice a day Storage: Room temperature (below 25℃) Duration of use: 8 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| WBC(White blood cell) Count | WBC(White blood cell) Count | at 8 week | 
| NK(Natural killer) cell activity | NK(Natural killer) cell activity | at 8 week | 
| Immune related indicator (IFN-γ, IL-2, 6, 12, TNF-α, IgG1, IgG2, IgM) | Immune related indicator (IFN-γ, IL-2, 6, 12, TNF-α, IgG1, IgG2, IgM) | at 8 week | 
| Evaluation of improvement by the subjects themselves | Evaluation of improvement by the subjects themselves (Excellent, Good, Unchanged, Worsening, Very aggravated / 5 Step) | at 8 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse reactions | Number of Participants with Adverse reactions | at 8 week | 
| Body temperature | Body temperature | at 8 week |