Study Evaluating the Quality and Effects of Lion's Mane Product on Cognitive Health

Recruiting now · Has a placebo group

Conditions studied: Cognitive Decline

In brief

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.

Key facts

Study ID: NCT06870136
Run by: M2 Ingredients
People needed: 150
Starts: 2025-02-21
Expected to finish: 2025-09-17
Last updated by the study team: 2025-03-11

Who can join

Age: 40 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

People Science — Los Angeles, California, United States (enrolling)

Full record on ClinicalTrials.gov

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