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

NCT06870136 | Recruiting

• 1 other identifier: PS14
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Impact on Attention, Short Term & Working Memory

  The primary outcome measure is to evaluate the impact of the Lion's Mane study product on a composite measure of Attention, Short Term \& Working Memory. This will be measured using the change from baseline in BrainHQ Cognitive Test Suite composite score at Week 8 between placebo and study product group.

  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.

Secondary Outcomes (9)

• Fluid intelligence and spatial memory

  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.

• Multiple object tracking, Visual and Numerical tasks

  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.

• Subjective awareness of cognitive failures

  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.

• Mood perception

  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.

• Perception of focus

  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.

Study Arms (2)

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.

Dietary Supplement: Lion's Mane Study Product

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 DIETARY_SUPPLEMENT

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.

Lion's Mane Study Product

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Participants between 40-75 years old experiencing reduced memory, focus, and cognitive decline. Participants will be recruited through People Science community, email outreach, physician network, advocacy groups and social media channels. Advertisements will be in digital format and will link to a study landing page to enable participant sign-up where they will complete a pre-screening qualification survey.

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

Sponsors & Collaborators

• M2 Ingredients: lead

Study Sites (1)

People Science

Los Angeles, California, 90034, United States

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Amy Kazaryan, MPhil

  People Science, Inc.

  STUDY DIRECTOR

Central Study Contacts

Amy Kazaryan, MPhil

CONTACT

8184528996; amy@peoplescience.health

Crisel Erfe, MD

CONTACT

crisel@peoplescience.health

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2025
• First Posted: March 11, 2025
• Study Start: February 21, 2025
• Primary Completion: July 25, 2025
• Study Completion: September 17, 2025
• Last Updated: March 11, 2025

Record last verified: 2025-03

Locations

US (1)