Safety Assessment of HEA-Enriched Mycelium: A Randomized Clinical Trial.

, a medicinal fungus, is assessed as having many functions: anti-cancer, anti-fatigue, anti-aging, immune-boosting, renal and liver protection. Since the industrial production of mycelium consistently manufactures bioactive compounds superior to wild fruiting bodies, there is a need to confirm the toxicity of liquid fermented mycelium. Studies showed the toxicity evaluation of mycelium in animal models, but safety reports in clinical studies are scarce. As such, a safety assessment of oral N6-(2-hydroxyethyl) adenosine (HEA-enriched) mycelium in humans is provided here. After 49 participants ingested granules of 1.05 g of freeze-dried mycelium once a day for 3 months, their blood samples were collected at the beginning and end of the experiment for analysis. There were no significant differences between the initial and final measurements in renal and liver function. Also, there was no influence on blood electrolytes as well as blood lipid levels. In clinical observation, there were also no side effects or adverse feelings mentioned by participants. These results suggested that HEA-enriched mycelium produced by liquid fermentation is safe and can be developed as a functional health food.