Healthy Adult FemalesNCT07405957
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
A study testing Lion Mane (Hericium erinaceus) fruiting body extract - Nordic Origin and Lions Mane (Hericium erinaceus) Fruiting body and mycelium in people with Healthy Adult Females and Healthy Adult Male, run by Applied Food Sciences Inc. at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Females, Healthy Adult Male
- What is being tested?
- Lion Mane (Hericium erinaceus) fruiting body extract - Nordic Origin and Lions Mane (Hericium erinaceus) Fruiting body and mycelium
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 87 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Feb 2025to 10 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Applied Health Sciences
Canfield, Ohio, 44406
About this study
Official title: 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.
Read the 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
- Being tested
- Lion Mane (Hericium erinaceus) fruiting body extract - Nordic Origin, Lions Mane (Hericium erinaceus) Fruiting body and mycelium, Maltodextrin (Placebo)
- Keywords
- Randomized, double blind, placebo controlled, Lions Mane, Hericium erinaceus, Fruiting Body, Mycelium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lion Mane (Hericium erinaceus) fruiting body extract - Nordic OriginDietary 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 myceliumDietary 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 group | Role | What they receive |
|---|---|---|
| Nordic Lions Mane (Hericium erinaceus) fruiting body extract | Experimental | 1 gram / day of active lions mane or placebo Receives: 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 Receives: Dietary Supplement: Lions Mane (Hericium erinaceus) Fruiting body and mycelium |
| Maltodextrin | Placebo comparator | Maltodextrin Receives: Other: Maltodextrin (Placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 45 days
Secondary outcomes (1)
Microbiome Diversity namely Faecalibacterium prausnitzii (expressed as copies per gram stool).
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).
Measured: 45 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2026
- Study start11 Feb 2025
- Primary completion27 Jun 2025
- Study completion10 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult FemalesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Applied Food Sciences Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The Center for Applied Health Sciences, LLC
- Responsible party
- Sponsor
- Investigators
- Michael B. La Monica, Ph.D., CSCS, Principal investigator, The Center for Applied Health Sciences, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07405957
- Sponsor's protocol ID
- AFS-01-2024
- Status last verified
- Feb 2026
- First submitted
- 6 Jan 2026
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Naturally Occurring Lions Mane Extract on Cognitive Performance, Serum Biomarkers and Indices of Affect (Pro00083830)
- ClinicalTrials.gov ID
- NCT07405957
- Acronym / sponsor ID
- AFS-01-2024
- Conditions
- Healthy Adult Females, Healthy Adult Male
- Keywords
- Randomized, double blind, placebo controlled, Lions Mane, Hericium erinaceus, Fruiting Body, Mycelium
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Applied Food Sciences Inc.Industry (pharma, biotech, devices)
- Collaborators
- The Center for Applied Health Sciences, LLC
- Study start
- 11 Feb 2025 (actual)
- Primary completion
- 27 Jun 2025 (actual)
- Study completion
- 10 Sep 2025 (actual)
- First posted
- 12 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Nordic Lions Mane (Hericium erinaceus) fruiting body extract | Experimental | Dietary Supplement: Lion Mane (Hericium erinaceus) fruiting body extract - Nordic Origin1 gram / day of active lions mane or placebo |
| Lions Mane (Hericium erinaceus) fruiting body and mycelium extract | Active comparator | Dietary Supplement: Lions Mane (Hericium erinaceus) Fruiting body and myceliumLions Mane (Hericium erinaceus) fruiting body and mycelium extract combined in equal portions |
| Maltodextrin | Placebo comparator | Other: Maltodextrin (Placebo)Maltodextrin |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lion Mane (Hericium erinaceus) fruiting body extract - Nordic OriginThis 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 | Nordic Lions Mane (Hericium erinaceus) fruiting body extract |
| Lions Mane (Hericium erinaceus) Fruiting body and myceliumThis 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. | Dietary supplement | Lions Mane (Hericium erinaceus) fruiting body and mycelium extract |
| Maltodextrin (Placebo)Maltodextrin (Placebo) | Other | Maltodextrin |
Primary outcome
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)
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
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)
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)
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)
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)
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)
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)
1 secondary outcome
Microbiome Diversity namely Faecalibacterium prausnitzii (expressed as copies per gram stool).
Time frame: 45 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael B. La Monica, Ph.D., CSCS principal investigator
The Center for Applied Health Sciences, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lion Mane (Hericium erinaceus) fruiting body extract - Nordic Origin and Lions Mane (Hericium erinaceus) Fruiting body and mycelium in people with Healthy Adult Females and Healthy Adult Male, run by Applied Food Sciences Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive function measured by Composite memory (Unit of Measure = milliseconds) (time frame: 45 days). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2026.