Evaluating Lion's Mane Mushroom Effects on Cognitive Health

A Direct-to-Consumer, Randomized, Double-blind, Placebo-controlled Study Evaluating the Quality and Effects of Lion's Mane Product on Cognitive Health Outcomes Through Self-Reported Measures

This study is testing whether taking Lion's Mane mushroom can help adults aged 40-75 who are worried about their memory and thinking skills feel better in areas like focus, mood, and sleep compared to a placebo.

Quick facts

• Study type: Observational
• Enrollment: 150 (estimated)
• Ages: 40 Years to 75 Years
• Sex: All
• Sponsor: M2 Ingredients (Industry-sponsored)
• Locations: 1 site (Los Angeles, California)
• Trial ID: NCT06870136 on ClinicalTrials.gov

What this trial studies

This observational study aims to assess the cognitive health outcomes of adults aged 40-75 who self-report concerns about memory and cognitive decline. Participants will be evaluated on their cognitive function, mood, focus, motivation, sleep quality, and stress levels after using a consumer-grade Lion's Mane mushroom product compared to a placebo. The study will utilize memory and cognitive function tests along with participant-reported questionnaires to gather data on the product's effects over a specified period. There is no direct doctor-patient relationship, as participants are consumers making informed choices about their involvement.

Who should consider this trial

Good fit: Ideal candidates are adults aged 40-75 who have self-reported concerns about their memory and cognitive function.

Not a fit: Patients who are not experiencing cognitive decline or those outside the age range of 40-75 may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into the cognitive health benefits of Lion's Mane mushroom products for individuals experiencing cognitive decline.

How similar studies have performed: Previous studies have shown promising results regarding the cognitive and mood-enhancing effects of Lion's Mane, suggesting that this approach may have a basis in existing research.

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 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.

Where this trial is running

Los Angeles, California

• People Science — Los Angeles, California, United States (Recruiting)

Study contacts

• Study coordinator: Amy Kazaryan, MPhil

Conditions Cognitive Decline