Study Evaluating the Quality and Effects of Lion's Mane Product on Cognitive Health
Recruiting
Observational Study
Cognitive Decline
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
40 – 75
Sex
Any
Study type
Observational
Participants needed
150 (estimated)
Sponsor
M2 Ingredients · Industry
Who this trial is looking for
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The rationale for this study is to observe differences in cognitive health outcomes such as short term memory and simple reaction time between a consumer-grade and commercially available Lion's mane mushroom product and a placebo control group. Additionally, the study aims to evaluate the impact of the product on cognitive function, mood, focus, motivation, sleep quality, and stress. A consumer-dr…
The rationale for this study is to observe differences in cognitive health outcomes such as short term memory and simple reaction time between a consumer-grade and commercially available Lion's mane mushroom product and a placebo control group. Additionally, the study aims to evaluate the impact of the product on cognitive function, mood, focus, motivation, sleep quality, and stress. A consumer-driven, decentralized observational clinical research study is therefore well-suited for evaluating the impact of this product in this population.
The study will evaluate cognitive health outcomes in a broad age-range of adults who have chosen to try this product. The study will incorporate memory and cognitive function tests, participant reported outcome questionnaires and surveys. There is no "doctor-patient" relationship as part of this research since the participant as a consumer is making the informed choice to take the product and participate in the observational process with self-reported measures that can be done at home. Findings from this study will contribute knowledge toward the functional mushrooms and cognitive health and the design of future studies.
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Eligibility Criteria
Inclusion Criteria:
* Individuals 40-75 years old, inclusive
* Has self-reported concerns with reduced memory, focus and cognitive decline
* Cognitive Failures Questionnaire score of mild to moderate at screening
* Interested in understanding more about their cognitive health and have chosen have c…
Inclusion Criteria:
* Individuals 40-75 years old, inclusive
* Has self-reported concerns with reduced memory, focus and cognitive decline
* Cognitive Failures Questionnaire score of mild to moderate at screening
* Interested in understanding more about their cognitive health and have chosen have chosen to use the study product
* Willing to do a 4-week washout from any supplements for memory or cognitive function prior to randomization
* Willing to do a 4-week washout prior to randomization from supplements with mushroom compounds or consuming mushrooms known to impact NGF. This includes but may not be limited to: Reishi (ganoderma lucidum), cordyceps (cordyceps militaris or cordyceps sinensis), Lion's mane or Coral Tooth Fungus (hericium coralloides), turkey tail (trametes versicolor), Chage (inonotus obliquus), Maitake (grifola frondosa).
* If taking prescription medications for sleep (e.g. Benzodiazepines, zolpidem, zaleplon), or other class of medication for sleep, must be on a "stable dose" for at least 4 weeks prior to enrollment. "Stable dose" is defined as no changes in dosage or frequency of the specified medications for at least 4 weeks prior to enrollment and throughout the study period.
* If regularly consuming alcohol, must be willing to stay on a stable amount throughout the study period and to log alcohol consumption.
* In good general health at the time of screening (Investigator discretion).
* Able to read and understand English.
* Able to read, understand, and provide informed consent.
* Able to use a personal smartphone device and laptop, download Chloe by People Science and use the BrainHQ web-based assessment platform.
* Able to receive shipment of the product at an address within the United States.
* Able to complete study assessments over the course of up to 9 weeks.
Exclusion Criteria:
Any potential participants who:
* Do not have a smartphone and/or internet access.
* Concomitant Therapies:
* Participants taking prescription medication for sleep (e.g. Benzodiazepines, zolpidem, zaleplon) not on a stable dose for at least 4 weeks
* Participants receiving Cognitive Behavioral Therapy for Insomnia (CBTi)
* Participants receiving any investigational therapies or treatments within 30 days prior to randomization.
* Other Illnesses or Conditions: Participants who have the following conditions or comorbidities are excluded:
* Diagnosis of Alzheimer's disease or dementia
* Diagnosed neurological condition or assessed as having a learning/behavioural or neurodevelopmental difference such as dyslexia or ADHD
* Have a visual impairment that cannot be corrected with glasses or contact lenses, including red green color blindness
* Deafness or untreated age-related hearing loss
* Confirmed diagnoses of the following sleep disorders: Narcolepsy, Restless Leg Syndrome, Circadian Rhythm Disorders
* Current or prior history of psychotic disorder
* Diagnosed with Alcohol or Substance Abuse Disorder
* Currently pregnant, planning to become pregnant at any time during the study, or breastfeeding
* Have a significant illness, disease or condition which, in the opinion of the principal investigator, may impact their ability to participate in the trial or impact the trial outcomes
* Long Covid including persistent feelings of brain fog
* Participants using any nicotine and cannabis-containing products
* Known hypersensitivity or previous allergic reaction to Lion's mane or functional mushrooms.
* Are unlikely for any reason to be able to comply with the trial or considered unsuited for participation in the study by the Principal Investigator.
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