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Recruiting NCT06870136

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

Trial Parameters

Condition Cognitive Decline
Sponsor M2 Ingredients
Study Type OBSERVATIONAL
Phase N/A
Enrollment 150
Sex ALL
Min Age 40 Years
Max Age 75 Years
Start Date 2025-02-21
Completion 2025-07-25
Interventions
Lion's Mane Study Product

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.

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 "st

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