RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2025-02-21

Study Completion:2025-09-17

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06870136

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:40 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Contact

Amy Kazaryan, MPhil

CONTACT

8184528996

amy@peoplescience.health

Crisel Erfe, MD

CONTACT

crisel@peoplescience.health

Principal Investigator

Amy Kazaryan, MPhil

STUDY_DIRECTOR

People Science, Inc.

Study Locations (Sites)

People Science

Los Angeles, California, 90034

United States

Collaborators and Investigators

Sponsor: M2 Ingredients

Amy Kazaryan, MPhil, STUDY_DIRECTOR, People Science, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-21

Study Completion Date2025-09-17

Study Record Updates

Study Start Date2025-02-21

Study Completion Date2025-09-17

Terms related to this study

Additional Relevant MeSH Terms

Cognitive Decline