NCT06870136

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

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 150 (estimated)
• Sponsor: M2 Ingredients · Industry
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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, neuroprotective, antioxidant, anti-tumor, anti-inflammatory, prebiotic, and gut-health promoting effects. The principal components of medical interest include polysaccharides, glycoproteins, hericenones, erinacines, and hericerin. Previous work has shown mood-enhancing effects following chronic administration of H. erinaceus with both studies showing improvements in depression and anxiety scores. More recently, a study on the acute and chronic effect of H. erinaceus suggested that it may improve speed of performance and reduce subjective stress in healthy, young adults. Similarly, another recent study observed improvements in cognitive function and changes in circulating brain-derived neurotrophic factor (BDNF) levels supporting the proposed neurotrophic and neuroprotective effects of the bioactive metabolites present in H. erinaceus. When looking specifically at the impact of H. erinaceus on memory, another study showed that oral intake of H. erinaceus significantly improved cognitive functions and prevented the deterioration of memory over time. Given the previous work in the literature on older adults and adults with comorbidities, there is a need to understand the benefits of H. erinaceus on cognitive health in a healthy adult population. In addition, given the variety of products on the market and the unique fingerprint of bioactive molecules in the mycelium and the fruit body of H. erinaceus, a study where the treatment consisted on both the mycelium and the fruit body would be beneficial to understanding this popular nutraceutical ingredient. H. erinaceus is a popular culinary mushroom species that is wild-harvested and cultivated in many countries. Thus, preparations made from liquid fermentation or solid-state fermentation processes provides a means to highly efficient, consistent, year-round production and allow for better quality control of the final product. The preparation used in this study is a certified organic powdered H. erinaceus (Strain M2-102-10) mycelial biomass and fruiting body cultured on organic whole oats (Avena sativa) in a controlled solid fermentation facility. The powder was encapsulated in vegetable cellulose capsules and each dose consisted of 2g of powder (3 capsules).

Conditions

• Cognitive Decline

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Lion'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.

Timeline

• Start date: 2025-02-21
• Primary completion: 2025-07-25
• Completion: 2025-09-17
• First posted: 2025-03-11
• Last updated: 2025-03-11

Locations

1 site across 1 country: United States