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

Part of paid clinical trials in Los Angeles, California.

Sponsor
M2 Ingredients
Study ID
NCT06870136
Status
Recruiting
Apply to this trial

Conditions

  • Cognitive Decline

Eligibility Criteria

Sex
ALL
Age
40 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Lion's Mane Study Product — DIETARY_SUPPLEMENT
    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.

Study Details

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.

Key Dates

Start date
Feb 21, 2025
Status verified
Mar 2025
Primary completion
Jul 25, 2025
Completion
Sep 17, 2025

Study Design

Enrollment
150 participants (estimated)

Arms

  • Arm: Lion's Mane Study Product
    Participants will be randomized to one of two groups A or B: (1) Lion's Mane Study Product, and (2) Placebo. The Investigators and study team and participants will be blinded to the group assignment.
  • Arm: Placebo
    Participants will be randomized to one of two groups A or B: (1) Lion's Mane Study Product, and (2) Placebo. The Investigators and study team and participants will be blinded to the group assignment.

Primary Outcome Measure

Impact on Attention, Short Term & Working Memory [ Time Frame: Participants will complete up to a 14-week study consisting of screening period, randomization and shipping period, a baseline period, and an 8-week product/placebo use period. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
People ScienceLos AngelesCalifornia90034
Amy Kazaryan, MPhil
[email protected]
818-452-8996

Find similar trials in Los Angeles, CA

By research site
People Science· Los Angeles, CA

Related Studies