NCT07405957

Effects of Two Different Lion's Mane Extracts (Lions Mane Fruiting Body & Lions Mane Fruiting Body With Mycellium) on Cognitive Performance, Subjective Affect, Serum Biomarkers, and Gut Microbiota in Healthy Adults

Effects of Naturally Occurring Lions Mane Extract on Cognitive Performance, Serum Biomarkers and Indices of Affect (Pro00083830)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 87 (actual)
• Sponsor: Applied Food Sciences Inc. · Industry
• Sex: All
• Age: 40 Years – 65 Years
• Healthy volunteers: Accepted

Summary

A randomized, double-blind, placebo-controlled, parallel-arm study design, of healthy men and women assigned to one of three groups: 1 gram/day of MycothriveTM Nordic origin fruiting body lion's mane (M-LM), 1 gram/day of a commercially available mycelium and fruiting body lion's mane (MFB-LM), or placebo (PL) to evaluate Lions mane potential cognitive and gut health benefits in a controlled daily dose for 45 days.

Detailed description

Lion's Mane (LM) contains β-glucan polysaccharides, proteins, polyketides, hericenones and erinacine terpenoids, cyathane diterpenoids, lectins, phenols, isoindolinones, sterols, and myconutrients, which have been found to provide cognitive and neuroprotective properties. Erinacines within the mycelium of lions mane have demonstrated nootropic effects through the stimulation of nerve growth factor (NGF) synthesis, which plays a critical role in the growth, maintenance, and survival of neurons within the central nervous system, particularly the basal forebrain cholinergic system. Acute affects were shown to improve working memory, complex attention, and reaction time and perceptions of happiness in Lions Mane Fruiting body. This study aims to determine key differences (if any) in cognitive tasks, subjective affect (e.g., VAS scales for mental clarity, memory, mood, focus, concentration), serum biomarkers (BDNF, TNF-alpha,IL-6, HS-CRP), microbiome (alpha \& beta diversity, keystone species, etc.) with daily consumption.

Conditions

• Healthy Adult Females
• Healthy Adult Male

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Lion Mane (Hericium erinaceus) fruiting body extract - Nordic Origin	This extract contains the fruiting body of the Hericium erinaceus, providing only active levels of triterpenoids and beta glucans found in the fruiting body alone.
DIETARY_SUPPLEMENT	Lions Mane (Hericium erinaceus) Fruiting body and mycelium	This extract contains both the fruiting body and the mycelium of the Hericium erinaceus, providing different levels of active triterpenoids and beta glucans than fruiting body alone.
OTHER	Maltodextrin (Placebo)	Maltodextrin (Placebo)

Timeline

• Start date: 2025-02-11
• Primary completion: 2025-06-27
• Completion: 2025-09-10
• First posted: 2026-02-12
• Last updated: 2026-02-13

Locations

1 site across 1 country: United States