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_SUPPLEMENTThis 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_SUPPLEMENTThis 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) — OTHERMaltodextrin (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 extract1 gram / day of active lions mane or placebo
- Active Comparator: Lions Mane (Hericium erinaceus) fruiting body and mycelium extractLions Mane (Hericium erinaceus) fruiting body and mycelium extract combined in equal portions
- Placebo Comparator: MaltodextrinMaltodextrin
Primary Outcome Measure
Cognitive function measured by Composite memory (Unit of Measure = milliseconds) [ Time Frame: 45 days ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Center for Applied Health Sciences | Canfield | Ohio | 44406 | - |
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