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

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.

NCT Number	NCT06870136
Lead Sponsor	M2 Ingredients
Conditions	Cognitive Decline
Enrollment	150 participants
Start Date	2025-02-21
Primary Completion	2025-07-25 (estimated)
Study Completion	2025-09-17 (estimated)
Updated on ClinicalTrials.gov	2025-03-11