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

February 11, 2026 updated by: Applied Food Sciences Inc.

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
87

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Canfield, Ohio, United States, 44406
        • Center for Applied Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria: Provide voluntary signed and dated informed consent.

  • 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.

Exclusion Criteria:Smokes more than 10 cigarettes per day or uses other nicotine products (i.e. vape, patch) that deliver a similar amount of nicotine.

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Maltodextrin
Other: Maltodextrin (Placebo)
Maltodextrin (Placebo)
Experimental: Nordic Lions Mane (Hericium erinaceus) fruiting body extract
1 gram / day of active lions mane or placebo
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.
Active Comparator: Lions Mane (Hericium erinaceus) fruiting body and mycelium extract
Lions Mane (Hericium erinaceus) fruiting body and mycelium extract combined in equal portions
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Cognitive function measured by Composite memory (Unit of Measure = milliseconds)
Time Frame: 45 days
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
Time Frame: 45 days
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)
Time Frame: 45 days
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)
Time Frame: 45 days
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)
Time Frame: 45 days
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)
Time Frame: 45 days
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)
Time Frame: 45 days
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)
Time Frame: 45 days
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Microbiome Diversity namely Faecalibacterium prausnitzii (expressed as copies per gram stool).
Time Frame: 45 days
Between and within-group changes in microbiome (alpha & beta diversity, keystone species, namely Faecalibacterium prausnitzii expressed as copies per gram stool). (Diagnostic Solutions Laboratory Alpharetta, GA).
45 days

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Heart rate measured in BPM
Time Frame: 45 days
Safety heart rate (BPM)
45 days
Blood Pressure measured by Systolic BP (mm Hg) Diastolic BP (mm Hg)
Time Frame: 45 Days
Description: Safety blood pressure: Systolic BP (mm Hg) Diastolic BP (mm Hg)
45 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Applied Food Sciences Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The Center for Applied Health Sciences, LLC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Michael B. La Monica, Ph.D., CSCS, The Center for Applied Health Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 11, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 27, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 10, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 6, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 10, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 12, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 11, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AFS-01-2024

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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