Subchronic Toxicity and Genotoxicity Studies of Hericium erinaceus β-Glucan Extract Preparation

Summary

This research evaluated the safety of Lion’s mane mushroom extract through comprehensive toxicology testing. The studies found no harmful effects even at high doses, supporting its safe use in food and supplements. Impact on everyday life: • Confirms the safety of Lion’s mane mushroom supplements for consumer use • Supports the development of new mushroom-based food products • Provides scientific backing for traditional uses of medicinal mushrooms • Helps establish safe dosage guidelines for supplement manufacturers • Gives consumers confidence in using Lion’s mane products

Background

Mushrooms have been consumed as food for millennia for their nutritional value and evaluated in Traditional Asian Medicine. Hericium erinaceus (Lion’s mane mushroom) is rich in β-glucans which have shown immunomodulating and antitumor effects. While toxicological studies on new sources of β-glucans have been conducted, a comprehensive safety profile of β-glucan extract from H. erinaceus has not yet been established.

Objective

To investigate potential adverse effects of a standardized H. erinaceus β-glucan extract preparation through mutagenicity studies (Ames test, in vitro chromosome aberration assay, in vivo micronucleus test) and a 90-day subchronic toxicity study in rats.

Results

Treatment with H. erinaceus β-glucan extract did not result in any toxicologically significant treatment-related changes in clinical observations, ophthalmic examinations, body weights, feed consumption, or organ weights. Clinical pathology including hematology, serum chemistry, urinalysis and terminal necropsy did not reveal any treatment-related adverse effects. The genotoxicity studies did not show any mutagenic potential.

Conclusion

Based on the subchronic study, the no observed-adverse-effect level (NOAEL) for H. erinaceus β-glucan extract preparation was determined as 2000 mg/kg bw/day, the highest dose tested. The extract showed no genotoxicity and appears safe for consumption at the tested doses.
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