Actively Recruiting
Study Evaluating the Quality and Effects of Lion's Mane Product on Cognitive Health
Led by M2 Ingredients · Updated on 2025-03-11
150
Participants Needed
1
Research Sites
29 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Study Evaluating the Quality and Effects of Lion's Mane Product on Cognitive Health
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Individuals 40-75 years old, inclusive
- Self-reported concerns with reduced memory, focus, or cognitive decline
- Mild to moderate score on Cognitive Failures Questionnaire at screening
- Interested in learning about their cognitive health and have chosen to use the study product
- Willing to stop memory or cognitive supplements for 4 weeks before randomization
- Willing to stop certain mushroom supplements or consuming mushrooms affecting nerve growth factor for 4 weeks before randomization
- Stable dose of sleep prescription medications for at least 4 weeks before enrollment if applicable
- Willing to maintain stable alcohol consumption and log intake during the study if consuming alcohol
- In good general health at screening
- Able to read and understand English and provide informed consent
- Able to use a smartphone and laptop and access required study platforms
- Able to receive product shipment within the United States
- Able to complete study assessments over up to 9 weeks
You will not qualify if you...
- No smartphone or internet access
- Taking sleep prescription medications not on a stable dose for at least 4 weeks
- Receiving Cognitive Behavioral Therapy for Insomnia
- Participating in any investigational therapies within 30 days before randomization
- Diagnosis of Alzheimer's disease or dementia
- Diagnosed neurological conditions or learning/behavioral differences such as dyslexia or ADHD
- Uncorrected visual impairment including red-green color blindness
- Deafness or untreated age-related hearing loss
- Diagnosed sleep disorders including narcolepsy, restless leg syndrome, circadian rhythm disorders
- Current or prior psychotic disorder
- Diagnosis of alcohol or substance abuse disorder
- Pregnant, planning pregnancy, or breastfeeding
- Significant illness or condition impacting participation or study outcomes
- Long Covid with persistent brain fog
- Use of nicotine or cannabis products
- Known allergy or reaction to Lion's Mane or functional mushrooms
- Unlikely to comply with study requirements or unsuited as judged by the principal investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
People Science
Los Angeles, California, United States, 90034
Actively Recruiting
Research Team
A
Amy Kazaryan, MPhil
CONTACT
C
Crisel Erfe, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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