Randomized trial Early signal 48 healthy Japanese adults aged 60 to 85 were randomized; 47 completed (placebo 14, Y10M 16, C5304 17)
Two Maitake strains produced different cognitive results in a small randomized trial
Forty-eight healthy older adults were randomized and 47 completed an 18-week trial. Y10M differed from placebo on adjusted post-intervention MoCA-J score (p=0.045) and MoCA-J change (p=0.040); C5304 did not. Neither strain differed from placebo on MMSE or HDS-R. No participant discontinued because of an adverse effect. This small, manufacturer-funded study does not establish dementia prevention or a general Maitake effect.
- What was studied
- Bread containing 50 g per day of fresh Maitake strain Y10M or C5304, compared with Maitake-free placebo bread, for 18 weeks
- Setting
- Studied alone
- Why it ranks here
- Randomization and active strain comparison strengthen the design, while the small groups, multiple cognitive outcomes, and a result seen for only one strain make replication essential.
Limits and cautions
- The three completion groups were small (14, 16, and 17), efficacy used a per-protocol analysis, and multiple cognitive, immune, and laboratory outcomes leave a meaningful risk of chance findings.
- The favorable cognitive result was strain-specific: C5304 did not differ from placebo on MoCA-J.
- Reported mean MoCA-J scores fell in the placebo group (26.9 to 25.9) while rising in the Y10M group (26.2 to 27.3), so the between-group difference reflects both changes, not improvement in the Y10M group alone. The paper's p-values come from baseline-adjusted ANCOVA models.
- Participants were healthy older Japanese adults; the trial did not enroll people with dementia or show prevention of cognitive decline.
- YUKIGUNI FACTORY funded the study, manufactured the Maitake test foods, and employed two authors; the paper states that the sponsor did not influence data collection or analysis.
- The study population was geographically restricted, diets were not controlled, genetic and other lifestyle factors were not analyzed, immune assessment was limited to natural-killer cells, and the authors could not explain the strain difference.
Maitake products are not FDA-approved to prevent or treat cognitive impairment, dementia, or another medical condition.