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| Name | Class |
|---|---|
| The Center for Applied Health Sciences, LLC | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nordic Lions Mane (Hericium erinaceus) fruiting body extract | Experimental | 1 gram / day of active lions mane or placebo |
|
| Lions Mane (Hericium erinaceus) fruiting body and mycelium extract | Active Comparator | Lions Mane (Hericium erinaceus) fruiting body and mycelium extract combined in equal portions |
|
| Maltodextrin | Placebo Comparator | Maltodextrin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 45 days |
| Measure | Description | Time Frame |
|---|---|---|
| Heart rate measured in BPM | Safety heart rate (BPM) | 45 days |
| Blood Pressure measured by Systolic BP (mm Hg) Diastolic BP (mm Hg) | Description: Safety blood pressure: Systolic BP (mm Hg) Diastolic BP (mm Hg) |
Inclusion Criteria: Provide voluntary signed and dated informed consent.
The average of all three measurements will be used to determine eligibility.
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.
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| Name | Affiliation | Role |
|---|---|---|
| Michael B. La Monica, Ph.D., CSCS | The Center for Applied Health Sciences, LLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Applied Health Sciences | Canfield | Ohio | 44406 | United States |
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| 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) |
|
| 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 |
| 45 Days |
| ID | Term |
|---|---|
| C008315 | maltodextrin |
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