Clinical trial NCT06870136: Study Evaluating the Quality and Effects of Lion's Mane Product on Cognitive Health
Official title: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cognitive Decline
Lead sponsor: M2 Ingredients
Sponsor class: INDUSTRY
First posted: 2025-03-11
Enrollment: 150
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

Detailed description: Mushrooms from the genera Hericium are among the many mushrooms known for their long history of traditional use. Hericium erinaceus (commonly known as Lion's Mane) is a wood-decaying basidiomycete that can grow on many tree species including birch, oak, maple, and beech trees. The fruiting body is white when fresh and yellowish with age. It consists of a rounded solid mass of spines that are 1-4cm long which hang down in a beardlike fashion. The mushroom is attached to the tree by a tough, thick, root-like structure.

H. erinaceus has been reported to have immunomodulatory, neurotrophic, neuroprotective, antioxidant, anti-tumor, anti-inflammatory, prebiotic, and gut-health promoting effects. The principal components of medical interest include polysaccharides, glycoproteins, hericenones, erinacines, and hericerin.

Previous work has shown mood-enhancing effects following chronic administration of H.

erinaceus with both studies showing improvements in depression and anxiety scores. More recently, a study on the acute and chronic effect of H. erinaceus suggested that it may improve speed of performance and reduce subjective stress in healthy, young adults. Similarly, another recent study observed improvements in cognitive function and changes in circulating brain-derived neurotrophic factor (BDNF) levels supporting the proposed neurotrophic and neuroprotective effects of the bioactive metabolites present in H. erinaceus. When looking specifically at the impact of H. erinaceus on memory, another study showed that oral intake of H. erinaceus significantly improved cognitive functions and prevented the deterioration of memory over time. Given the previous work in the literature on older adults and adults with comorbidities, there is a need to understand the benefits of H. erinaceus on cognitive health in a healthy adult population. In addition, given the variety of products on the market and the unique fingerprint of bioactive molecules in the mycelium and the fruit body of H. erinaceus, a study where the treatment consisted on both the mycelium and the fruit body would be beneficial to understanding this popular nutraceutical ingredient.

H. erinaceus is a popular culinary mushroom species that is wild-harvested and cultivated in many countries. Thus, preparations made from liquid fermentation or solid-state fermentation processes provides a means to highly efficient, consistent, year-round production and allow for better quality control of the final product. The preparation used in this study is a certified organic powdered H. erinaceus (Strain M2-102-10) mycelial biomass and fruiting body cultured on organic whole oats (Avena sativa) in a controlled solid fermentation facility. The powder was encapsulated in vegetable cellulose capsules and each dose consisted of 2g of powder (3 capsules).

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.

Primary outcomes:
measure: Impact on Attention, Short Term & Working Memory
timeFrame: 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:
measure: Fluid intelligence and spatial memory
timeFrame: 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.
measure: Multiple object tracking, Visual and Numerical tasks
timeFrame: 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.
measure: Subjective awareness of cognitive failures
timeFrame: 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.
measure: Mood perception
timeFrame: 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.
measure: Perception of focus
timeFrame: 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.
measure: Subjective Motivation
timeFrame: 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.
measure: Sleep quality
timeFrame: 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.
measure: Daytime alertness
timeFrame: 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.
measure: Stress
timeFrame: 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.
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: People Science
state: California
Study officials:
affiliation: People Science, Inc.
name: Amy Kazaryan, MPhil
role: STUDY_DIRECTOR
References: