Černelič Bizjak M., Jenko Pražnikar Z., Kenig S., Hladnik M., Bandelj D., Gregori A., Kranjc K. Effect of erinacine A-enriched Hericium erinaceus supplementation on cognition: A randomized, double-blind, placebo-controlled pilot study. Journal of Functional Foods. 2024;115:106120.
Rationale
The erinacine A-enriched mycelium line is the most standardized lion's mane preparation in clinical research — the same product family used in the 49-week Alzheimer's pilot. This pilot added a mechanistic layer: gut-microbiota sequencing and neuropeptide measures alongside cognition.
Methods
A double-blind 8-week pilot RCT: 33 participants randomized to erinacine A-enriched mycelium or placebo, with cognitive testing, serum BDNF/NPY/CHI3L1 measures and 16S-based gut-microbiota profiling.
Results
The active group improved significantly on nonverbal speed-based cognitive tests (after adjusting for baseline cognitive score, CHI3L1, age and sex). Gut microbiota diversity rose significantly in the active arm and correlated positively with NPY levels; serum BDNF changes were not reported as significant in the abstract. Tolerability: excellent, no serious adverse events.
Conclusions
A coherent, if preliminary, picture: cognitive gain + microbiota diversification + an NPY correlation — pointing at a gut–brain-axis mechanism worth testing at scale.
Worth noting
n=33 and a pilot design: the microbiota correlation is hypothesis-generating, not mechanistic proof. The adjusted-covariates analysis is methodologically honest. Notable that BDNF did not clearly move — the neurotrophin story in humans remains more hypothesis than measurement.