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

NCT07405957 | Completed

• 1 other identifier: AFS-01-2024
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Adult Females; Healthy Adult Male

Keywords

Randomized, double blind, placebo controlled, Lions Mane; Hericium erinaceus; Fruiting Body; Mycelium

Outcome Measures

Primary Outcomes (8)

• Cognitive function measured by Composite memory (Unit of Measure = milliseconds)

  Cognitive performance will be assessed using CNS Vital Signs, a computerized neurocognitive testing platform that provides a validated assessment of cognitive function. Outcome composite memory (Unit of Measure = milliseconds)

  45 days

• Cognitive Performance in visual memory, Unit of Measure = milliseconds

  Cognitive performance will be assessed using CNS Vital Signs, a computerized neurocognitive testing platform that provides a validated assessment of cognitive function. Outcome visual memory, Unit of Measure = milliseconds

  45 days

• Cognitive Function in verbal memory (the ability to recognize, remember, and retrieve words and geometric figures). (Unit of Measure = milliseconds)

  Cognitive performance will be assessed using CNS Vital Signs, a computerized neurocognitive testing platform that provides a validated assessment of cognitive function. Outcome Measure verbal memory (the ability to recognize, remember, and retrieve words and geometric figures). (Unit of Measure = milliseconds)

  45 days

• Cognitive Function in reaction time (the ability to react to a simple and increasingly complex direction set) (Unit of Measure = milliseconds)

  Cognitive performance will be assessed using CNS Vital Signs, a computerized neurocognitive testing platform that provides a validated assessment of cognitive function. Outcome measure: reaction time (the ability to react to a simple and increasingly complex direction set) (Unit of Measure = milliseconds)

  45 days

• Cognitive flexibility (the ability to adapt to rapidly changing and increasingly complex set of directions) (Unit of Measure = milliseconds)

  Cognitive performance will be assessed using CNS Vital Signs, a computerized neurocognitive testing platform that provides a validated assessment of cognitive function. Outcome measure: cognitive flexibility (the ability to adapt to rapidly changing and increasingly complex set of directions) (Unit of Measure = milliseconds)

  45 days

• Cognitive Function measured by executive function (the ability to recognize rules and categories, and manage or navigate rapid decision making) (Unit of Measure = milliseconds)

  Cognitive performance will be assessed using CNS Vital Signs, a computerized neurocognitive testing platform that provides a validated assessment of cognitive function. Outcome Measure: executive function (the ability to recognize rules and categories, and manage or navigate rapid decision making) (Unit of Measure = milliseconds)

  45 days

• Cognitive Function measured by motor speed (the ability to perform movements to produce and satisfy an intention towards a manual action and goal) (Unit of Measure = milliseconds)

  Cognitive performance will be assessed using CNS Vital Signs, a computerized neurocognitive testing platform that provides a validated assessment of cognitive function. Outcome Measure: motor speed (the ability to perform movements to produce and satisfy an intention towards a manual action and goal) (Unit of Measure = milliseconds)

  45 days

• Cognitive Function measured by psychomotor speed (the ability to perceive and respond to visual-perceptual information and perform motor speed and fine motor coordination) (Unit of Measure = milliseconds)

  Cognitive performance will be assessed using CNS Vital Signs, a computerized neurocognitive testing platform that provides a validated assessment of cognitive function. Outcome Measure: psychomotor speed (the ability to perceive and respond to visual-perceptual information and perform motor speed and fine motor coordination) (Unit of Measure = milliseconds)

  45 days

Secondary Outcomes (1)

• Microbiome Diversity namely Faecalibacterium prausnitzii (expressed as copies per gram stool).

  45 days

Other Outcomes (2)

• Heart rate measured in BPM

  45 days

• Blood Pressure measured by Systolic BP (mm Hg) Diastolic BP (mm Hg)

  45 Days

Study Arms (3)

Nordic Lions Mane (Hericium erinaceus) fruiting body extract

EXPERIMENTAL

1 gram / day of active lions mane or placebo

Dietary Supplement: Lion Mane (Hericium erinaceus) fruiting body extract - Nordic Origin

Lions Mane (Hericium erinaceus) fruiting body and mycelium extract

ACTIVE COMPARATOR

Lions Mane (Hericium erinaceus) fruiting body and mycelium extract combined in equal portions

Dietary Supplement: Lions Mane (Hericium erinaceus) Fruiting body and mycelium

Maltodextrin

PLACEBO COMPARATOR

Maltodextrin

Other: Maltodextrin (Placebo)

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.

Nordic Lions Mane (Hericium erinaceus) fruiting body extract

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.

Lions Mane (Hericium erinaceus) fruiting body and mycelium extract

Maltodextrin (Placebo) OTHER

Maltodextrin (Placebo)

Maltodextrin

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be in good health and able to participate in cognitive performance testing as determined by assessment, medical history, and routine blood chemistries.
• Between the of 40 and 65 years of age (inclusive).
• Body Mass Index of 18.5-39.9 (inclusive).
• Body weight of at least 110 pounds.
• Normotensive (seated, resting systolic blood pressure \<140 mm Hg and diastolic blood pressure \< 90 mm Hg. If the first measurement is slightly elevated above these limits, the subject will be given a brief (5-minute) rest period, and two more measurements will be taken.
• The average of all three measurements will be used to determine eligibility.
• Normal supine, resting heart rate (\<90 per minute).
• Able to provide an adequate blood draw.
• If a dietary supplement was initiated within the past month, the participant is willing to discontinue supplement use followed by a 2-week washout prior to participation in the study.
• Willing to duplicate their previous 24-hour diet, refrain from caffeine for 12 hours, refrain from exercise for 24 hours prior to each trial, and fast for 8 hours prior to each visit.

You may not qualify if:

• History of malignancy in the previous 5 years except for non-melanoma skin cancer (basal cell cancer or squamous cell cancer of the skin).
• Prior gastrointestinal bypass surgery (Lapband, etc.).
• Other known gastrointestinal or metabolic diseases that might impact nutrient absorption or metabolism, e.g. electrolyte abnormalities, diabetes, thyroid disease, adrenal disease, hypogonadism, short bowel syndrome, diarrheal illnesses, history of colon resection, gastric ulcer, reflux disease, gastroparesis, Inborn-Errors-of-Metabolism (such as PKU). Chronic medically diagnosed inflammatory condition or disease (e.g. rheumatoid arthritis, Crohn's disease, ulcerative colitis, Lupus, HIV/AIDS, etc.).
• Medical history of hepatorenal, musculoskeletal, autoimmune, or neurologic disease.
• Medical history of a cognitive or psychiatric disorder.
• Currently using medications to treat anxiety or depression.
• Known sensitivity to any ingredient in the test formulations as listed in the Certificates- of-Analysis.
• Women currently pregnant, trying to become pregnant or breastfeeding a child.
• Any other diseases or conditions that, in the opinion of the medical staff, could confound the primary endpoint or place the subject at increased risk of harm if they were to participate.

Sponsors & Collaborators

• Applied Food Sciences Inc.: lead
• The Center for Applied Health Sciences, LLC: collaborator

Study Sites (1)

Center for Applied Health Sciences

Canfield, Ohio, 44406, United States

Location

MeSH Terms

Interventions

maltodextrin

Study Officials

• Michael B. La Monica, Ph.D., CSCS

  The Center for Applied Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2026
• First Posted: February 12, 2026
• Study Start: February 11, 2025
• Primary Completion: June 27, 2025
• Study Completion: September 10, 2025
• Last Updated: February 13, 2026

Record last verified: 2026-02

Locations

US (1)