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
M2 Ingredients
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.
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. H. erinaceus has been reported to have immunomodulatory, neurotrophic, neuro…
Eligibility
- Age range
- 40–75 years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- Dietary SupplementLion's Mane Study Product
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.
Location
- People ScienceLos Angeles, California