<i>In vitro </i>and <i>in vivo</i> toxicological assessments of <i>Antrodia cinnamomea</i> health food product (Leader <i>Antrodia cinnamomea</i> Capsule)

Abstract

A unique medicinal mushroom Antrodia cinnamomea has been used for centuries to treat various human diseases. Recent studies revealed its potent pharmacological effects including anticancer, anti-inflammation, anti-oxidant, anti-diabetic, neuroprotection and hepatoprotection. The present study was aimed to investigate the toxicological effects of A. cinnamomea health food product "Leader Antrodia cinnamomea Capsule (LACC)" by measuring its genotoxic, oral toxic and teratotoxic effects in vitro and in vivo. Result of Ames test with 5 strains of Salmonella typhimurium shows no sign of increase in the numbers of revertant colonies upon exposure to LACC. Treatment of Chinese Hamster Ovary cells (CHO-K1) with LACC did not affect increase in the frequency of chromosomal aberration in vitro. In addition, treatment with LACC did not affect the proportions of immature to total erythrocytes and the number of micronuclei in the immature erythrocytes of ICR mice. Moreover, acute oral toxicity (14-days single-dose) or prolonged oral toxicity (28-and 90-days repeated oral dose) tests with rats showed that there were no observable adverse effects were found. Furthermore, teratological studies with LACC (500-2500 mg/kg/day) for 20 days, shows no observable segment II reproductive and developmental toxic evidences in pregnant SD rats and their fetus. These toxicological assessments strongly support the safety efficacy of LACC for human consumption.

A Pilot Study to Assess Food Safety and Potential Cholesterol‐Lowering Efficacy of Antrodia cinnamomea Solid‐State Cultivated Mycelium in Healthy Adults

“…Antrodia cinnamomea may contain different bioactive compounds due to differences in culture (liquid, solid, or wood culture) and extraction methods and locations. e solid-state culture Antrodia cinnamomea mycelium powder (LAC) consumed as a health food in Taiwan contains two main bioactive compounds, triterpenoids (≥20.00 mg/g) and adenosine (≥0.20 mg/g), and its safety and specific and nonspecific immune regulatory functions have been confirmed by animal studies [18,19]. is is the first study to evaluate the safety and efficacy of the solid-state culture mycelium of Antrodia cinnamomea on healthy humans.…”

“…We also confirmed that LAC had no adverse effects on the kidney function of healthy subjects, and the change in albumin was also within the normal range, which is consistent with our toxicity test results in an animal model. [18,19] e data shows that oral LAC has no adverse effects on liver and kidney function in adults.…”

“…Recent studies have revealed that Antrodia cinnamomea mycelium extract has a variety of biological activities, such as hypolipidemic, antidiabetic [3,6,7], anticancer [8][9][10], antinflammatory [11,12], liver protection [13][14][15], and immunomodulatory effects [16,17]. e toxicology and effects of solid-state cultivated mycelium powder of Antrodia cinnamomea on liver function and immune regulation have been investigated in cell and animal models in the health food industry; [18][19][20] however, clinical data is still limited. To verify the food safety and potential efficacy of Antrodia cinnamomea solid-state cultivated mycelium, we conducted a nonrandomized, open-label, single-arm study in healthy adults to examine changes in blood biochemical parameters before and after Antrodia cinnamomea consumption.…”

Preclinical Safety Pharmacology Studies of Taiwanofungus camphoratus Extract

“…Huang et al [14], demonstrated that under the dosage of 6 g/kg of T. camphoratus showed no sub-chronic toxicity and teratogenicity in SD rats. Our previous studies also found the health food product "Leader Deluxe Antrodia cinnamomea" and "Leader Antrodia cinnamomea capsule" have no obvious toxic evidences in rats at dose of 2800 and 2500 mg/kg, respectively [15,16]. The maximum tolerated dose (MTD) of the solid-state cultivated mycelial powder of Antrodia cinnamomea (LE-SC) was greater than 13.3 g/kg bw and 90 days repeated dose oral toxicity studies also showed no significant toxicity signs in both male and female rats up to the dose of 7.6 g/kg bw [17].…”

Safety of freeze‐dried mycelia of Antrodia camphorata as a novel food pursuant to regulation (EU) 2015/2283

“…Thus, the Panel considers that these studies do not provide support to the assessment of the NF. The publications by Lin et al (2015Lin et al ( , 2016 relate to powders of mycelia of Antrodia camphorata that were produced with solid-state cultivation processes (even though not explicitly detailed). Although the test materials may not be fully representative of the NF, they may have similarities to the NF, and therefore, the Panel considers that the studies by Lin et al (2015Lin et al ( , 2016 provide support to the assessment of the NF.…”