Cognitive DeclineNCT06870136
Study Evaluating the Quality and Effects of Lion's Mane Product on Cognitive Health
An observational study of Cognitive Decline, run by M2 Ingredients at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Cognitive Decline
- What is being tested?
- Lion's Mane Study Product
- Type of treatment
- Pill or oral medicine
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Feb 2025to 17 Sep 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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).
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Crisel Erfe, MD contact
United States1 site, 1 recruiting
- Recruiting
People Science
Los Angeles, California, 90034
Amy Kazaryan, MPhil, 818-452-8996, amy@peoplescience.health
About this study
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
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.
Read the 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.
- 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.
- 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).
- Conditions
- Cognitive Decline
- Being tested
- Lion's Mane Study Product
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lion's Mane Study ProductDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
The secondary outcome will be to evaluate the impact of the Lion's mane study product on fluid intelligence and spatial memory. This will be measured using the change in overall fluid intelligence and spatial memory between placebo and study product group between placebo as measured by Sandia's progressive matrices, spatial memory and visual search task, grid memory task and shape rotation score. Baseline period will be compared as well.
Measured: 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
The secondary outcome will be to evaluate the impact of the Lion's mane study product on multiple object tracking, visual and numerical tasks. This will be done using the change in cognitive function as measured by Cognitive Failures Questionnaire score between placebo and study product group. Baseline period will be compared as well.
Measured: 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
The secondary outcome will be to evaluate the impact of the Lion's mane study product on subjective awareness of cognitive failures. This will be done using the change in average mood score as measured by a daily 10-point visual analogue rating scale (VAS) between the study product and placebo group Baseline period will be compared as well.
Measured: 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
The secondary outcome will be to evaluate the impact of the Lion's mane study product on mood perception. This will be done using the change in average subjective focus as measured by a daily 10-point visual analogue rating scale (VAS) between the study product and placebo group Baseline period will be compared as well.
Measured: 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
The secondary outcome will be to evaluate the impact of the Lion's mane study product on perception of focus. This will be done using the change in average subjective motivation as measured by a daily 10-point visual analogue rating scale (VAS) between the study product and placebo group Baseline period will be compared as well.
Measured: 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 Motivation
The secondary objective will be to evaluate the impact of the Lion's mane study product on subjective motivation. This will be done using the change in average subjective motivation as measured by a daily 10-point visual analogue rating scale (VAS) between the study product and placebo group Baseline period will be compared as well.
Measured: 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.
Sleep quality
The secondary objective will be to evaluate the impact of the Lion's mane study product on sleep quality. This will be done using the change in average sleep quality score as measured by a daily 10-point visual analogue rating scale (VAS) between the study product and placebo group Baseline period will be compared as well.
Measured: 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.
Daytime alertness
The secondary objective will be to evaluate the impact of the Lion's mane study product on daytime alertness. This will be done using the change in average daytime alertness score as measured by a daily 10-point visual analogue rating scale (VAS) between the study product and placebo group Baseline period will be compared as well.
Measured: 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.
Stress
The secondary objective will be to evaluate the impact of the Lion's mane study product on stress. This will be done using the change in average stress score as measured by a daily 10-point visual analogue rating scale (VAS) between the study product and placebo group Baseline period will be compared as well.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2025
- Study start21 Feb 2025
- Primary completion25 Jul 2025 (estimated)
- Study completion17 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive DeclineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M2 Ingredients
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Amy Kazaryan, MPhil, Study director, People Science, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06870136
- Sponsor's protocol ID
- PS14
- Status last verified
- Mar 2025
- First submitted
- 5 Mar 2025
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06870136
- Acronym / sponsor ID
- PS14
- Conditions
- Cognitive Decline
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- M2 IngredientsIndustry (pharma, biotech, devices)
- Study start
- 21 Feb 2025 (actual)
- Primary completion
- 25 Jul 2025 (estimated)
- Study completion
- 17 Sep 2025 (estimated)
- First posted
- 11 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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.
- 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).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lion's Mane Study Product | – | Dietary Supplement: Lion's Mane Study ProductParticipants 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. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (20 listed)
- Do not have a smartphone and/or internet access.
- Concomitant Therapies:
- Other Illnesses or Conditions: Participants who have the following conditions or comorbidities are excluded:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lion's Mane Study ProductThe 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. | Dietary supplement | Lion's Mane Study Product |
Primary outcome
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.
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.
9 secondary outcomes
Fluid intelligence and spatial 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.
Multiple object tracking, Visual and Numerical tasks
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.
Subjective awareness of cognitive failures
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.
Mood perception
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.
Perception of focus
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.
Subjective Motivation
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.
Sleep quality
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.
Daytime alertness
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.
Stress
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Crisel Erfe, MD contact
Amy Kazaryan, MPhil study director
People Science, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cognitive Decline, run by M2 Ingredients at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amy Kazaryan, MPhil (8184528996, amy@peoplescience.health), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2025.