Safety assessment of a proprietary fermented soybean solution, Symbiota?, as an ingredient for use in foods and dietary supplements: Non-clinical studies and a randomized trial

A safety evaluation was performed of Symbiota (R), which is made by a proprietary anaerobic fermentation process of soybean with multistrains of probiotics and a yeast. The battery of genotoxicity studies showed that Symbiota (R) has no genotoxic effects. Safety and tolerability were further assessed by acute or repeated dose 28- and 90-day rodent studies, and no alterations in clinical observations, ophthalmological examination, blood chemistry, urinalysis, or hematology were observed between the control group and the different dosing groups (1.5, 5, and 15 mL/kg/day). There were no adverse effects on specific tissues or organs in terms of weight and histopathology. Importantly, the Symbiota (R) treatment did not perturb hormones and other endocrine-related endpoints. Of note, the No-Observed-Adverse-Effect-Level was determined to be 15 mL/kg/day in rats. Moreover, a randomized, double-blind, placebo-controlled clinical trial was recently conducted with healthy volunteers who consumed 8 mL/day of placebo or Symbiota (R) for 8 weeks. Only mild adverse events were reported in both groups, and the blood chemistry and blood cell profiles were also similar between the two groups. In summary, this study concluded that the oral consumption of Symbiota (R) at 8 mL/day by the general population does not pose any human health concerns. This study provided a comprehensive safety assessment through the battery of guideline-compliant pre-clinical studies and a placebo-controlled clinical trial to support the safety of Symbiota (R) (MS-20) consumption as a nutritional and functional ingredient in selected foods for the general population within the proposed use levels. Image created with .image