Recruiting

Lion's Mane

Sponsor:

M2 Ingredients

Code:

NCT06870136

Conditions

Cognitive Decline

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Interventions

Lion's Mane Study Product

Study Details

Brief summary:

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.

Conditions

Cognitive Decline

Study ID

NCT06870136

Start date

Feb 21, 2025

Status verified date

Mar, 2025

Completion date

Sep 17, 2025

Anticipated

Primary completion date

Jul 25, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

150 participants

Anticipated

Interventions and Outcome Measures

Arms

Lion's Mane Study Product

Participants will be randomized to one of two groups A or B: (1) Lion's Mane Study Product, and (2) Placebo. The Investigators and study team and participants will be blinded to the group assignment.

Placebo

Participants will be randomized to one of two groups A or B: (1) Lion's Mane Study Product, and (2) Placebo. The Investigators and study team and participants will be blinded to the group assignment.

Interventions

Lion's Mane Study Product

The Lion's Mane Study product contains vegetable cellulose (capsules), Certified organic Lion's Mane (Hericium erinaceus) fruiting body and mycelial biomass cultured on certified whole oats (Avena sativa). Screening assessments, scales and surveys during baseline and during the use of the study product/placebo and end of study experience survey data will be collected.

Primary outcome measure

  • Impact on Attention, Short Term & Working Memory [ Time Frame: Participants will complete up to a 14-week study consisting of screening period, randomization and shipping period, a baseline period, and an 8-week product/placebo use period. ]

Central Contacts and Locations

Central contacts

Amy Kazaryan, MPhil

8184528996amy@peoplescience.health

Crisel Erfe, MD

crisel@peoplescience.health

Locations

People Science

Recruiting

Los Angeles, California, United States, 90034

Contacts

Amy Kazaryan, MPhil

818-452-8996amy@peoplescience.health

More Information

Sponsor

M2 Ingredients

Last update posted

Mar 11, 2025

Last verified

Mar, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by M2 Ingredients on 2025-03-11.