Safety Assessment of HEA-Enriched Cordyceps cicadae Mycelium: A Randomized Clinical Trial. Journal of the American College of Nutrition. 2021;40(2):127–132.
Rationale
Cordyceps cicadae is an entomopathogenic fungus parasitizing cicada nymphs; tradition attributes antitumor, antifatigue and nephro-/hepatoprotective action to it. Industrial liquid-fermentation mycelium production gives stable raw material with a marker content of N6-(2-hydroxyethyl)adenosine (HEA) — but preclinical toxicology alone does not answer whether the product is safe in humans. Clinical safety reports for fermented mycelium were scarce at the time.
Methods
A randomized clinical safety study. 49 participants took granules of lyophilized HEA-enriched C. cicadae mycelium — 1.05 g once daily for 3 months. Blood was drawn before and after the course. Panel: kidney and liver function markers, blood electrolytes, lipid profile. Subjective complaints and adverse events were recorded under clinical observation.
Results
- Biochemistry: no significant differences between baseline and final kidney and liver function measurements.
- Electrolytes and lipids: no effect on blood electrolytes or lipid profile recorded.
- Tolerance: under clinical observation, participants reported no adverse effects or complaints.
Conclusions
The authors conclude that HEA-enriched liquid-fermented C. cicadae mycelium at 1.05 g/day for 3 months is safe and can be considered raw material for functional products.
Worth noting
Strengths: a study devoted entirely to safety — a rare design for mushroom raw material; objective laboratory endpoints (kidney, liver, electrolytes, lipids) instead of subjective questionnaires.
Limitations:
- 3 months at 1.05 g/day — one dose and a short horizon; chronic intake safety (a year or more) and dose dependence were not studied.
- One intake arm in the abstract; how randomization and control were arranged is not disclosed in the abstract — methodological detail requires the full text.
- Healthy sample: n=49 without serious disease — does not answer safety in liver/kidney patients, pregnant women or children.
- Product specificity: HEA-enriched fermented mycelium ≠ dried wild cordyceps and ≠ extracts from other manufacturers with different adenosine-compound profiles.