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

Part of paid clinical trials in Canfield, Ohio.

Sponsor
Applied Food Sciences Inc.
Study ID
NCT07405957
Status
Completed

Conditions

  • Healthy Adult Females
  • Healthy Adult Male

Eligibility Criteria

Sex
ALL
Age
40 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Lion Mane (Hericium erinaceus) fruiting body extract - Nordic Origin — DIETARY_SUPPLEMENT
    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.
  • Lions Mane (Hericium erinaceus) Fruiting body and mycelium — DIETARY_SUPPLEMENT
    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.
  • Maltodextrin (Placebo) — OTHER
    Maltodextrin (Placebo)

Study Details

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.

Key Dates

Start date
Feb 11, 2025
Status verified
Feb 2026
Primary completion
Jun 27, 2025
Completion
Sep 10, 2025

Study Design

Enrollment
87 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Nordic Lions Mane (Hericium erinaceus) fruiting body extract
    1 gram / day of active lions mane or placebo
  • Active Comparator: Lions Mane (Hericium erinaceus) fruiting body and mycelium extract
    Lions Mane (Hericium erinaceus) fruiting body and mycelium extract combined in equal portions
  • Placebo Comparator: Maltodextrin
    Maltodextrin

Primary Outcome Measure

Cognitive function measured by Composite memory (Unit of Measure = milliseconds) [ Time Frame: 45 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
Center for Applied Health SciencesCanfieldOhio44406-

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