Immune activation of Bio-Germanium in a randomized, double-blind, placebo-controlled clinical trial with 130 human subjects: Therapeutic opportunities from new insights

Germanium has long been considered a therapeutic agent with anticancer, antitumor, antiaging, antiviral and anti-inflammatory effects. Numerous clinical studies have explored the promising therapeutic effects of organic germanium on cancer, arthritis and senile osteoporosis. The immune activation property of organic germanium is considered the foundation of its various therapeutic effects. However, previous human clinical studies investigating immune activation with organic germanium compounds have certain limitations, as some studies did not strictly follow a randomized, double-blind, placebo-controlled design. To build a more clinically substantiated foundation for the mechanism underlying its immunostimulation, we structured by far the most rigorous clinical study to-date with a group of 130 human subjects to examine changes in immune profiles following germanium supplementation. We used Bio-Germanium, an organic germanium compound naturally synthesized via a yeast fermentation process. An 8-week randomized, double-blind, placebo-controlled study was conducted with 130 subjects with leukocyte counts of 4–8 (×10(3)/μL) divided into the Bio-Germanium group and the placebo group. Anthropometric measurements; blood collection; biochemical analysis; urinalysis; and natural killer cell activity, cytokine and immunoglobulin assays were conducted. Results showed the Bio-Germanium group exhibited NK cell activity increases at effector cell:target cell (E:T) ratios of 50:1, 10:1, 5:1 and 2.5:1 (12.60±32.91%, 10.19±23.88%, 9.28±16.49% and 7.27±15.28%, respectively), but the placebo group showed decreases (P<0.01). The difference in the IgG1 change from baseline to follow-up between the Bio-Germanium and placebo groups was significant (P = 0.044). Our results and earlier clinical study of Bio-Germanium confirm that Bio-Germanium acts as an effective immunostimulant by increasing the cytotoxicity of NK cells and activating immunoglobulin, B cells and tumor necrosis factor (TNF)-α (P<0.05). As we have added newly discovered clinical findings for germanium’s immunostimulation mechanism, we believe Bio-Germanium is a highly promising therapeutic agent and should certainly be further explored for potential development opportunities in immunotherapy. REGISTERED CLINICAL TRIAL: [NCT03677921]; www.clinicaltrials.gov [KCT0002726]; https://cris.nih.go.kr