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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Investigational Group- Bio-Germanium | Experimental |
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| Control Group - Placebo Product | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Investigational Product (Bio-Germanium) | Dietary Supplement |
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| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse reactions | Number of Participants with Adverse reactions | at 8 week |
| Body temperature | Body temperature | at 8 week |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| JONGHO LEE, Ph.D. | Yonsei University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Laboratory of Clinical Nutrigenetics/Nutrigenomics, Yonsei University. | Seoul | 03722 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33075061 | Derived | Cho JM, Chae J, Jeong SR, Moon MJ, Shin DY, Lee JH. Immune activation of Bio-Germanium in a randomized, double-blind, placebo-controlled clinical trial with 130 human subjects: Therapeutic opportunities from new insights. PLoS One. 2020 Oct 19;15(10):e0240358. doi: 10.1371/journal.pone.0240358. eCollection 2020. |
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| Control Group - Placebo Product | Dietary Supplement |
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