診療と新薬 2026；63（6）：369-385

Shinryo to Shinyaku （Med Cons New-Remed）2026；63（6）：369-385

Effects of a Capsule Containing Clostridium butyricum, 3-(4-Hydroxy-3-methoxyphenyl) propionic Acid, and Salmon Milt-Derived DNA on Cognitive Function in Middle-Aged and Older Adults: A 12-Week Randomized, Double-Blind, Placebo-Controlled Trial

Yuji TANAKA 1)，Misato IKI 1)，Ayane UNO 2)，Shukuko EBIHARA 3)

1) Research and Development Department, NICORIO Co., Ltd., Tokyo, Japan，2) Research and Development Department, Ortho Corporation, Tokyo, Japan，3) Chiyoda Paramedical Care Clinic, Tokyo, Japan

Objective: To investigate whether a capsule containing Clostridium butyricum , 3-(4-hydroxy-3-methoxyphenyl) propionic acid (HMPA), and salmon milt-derived DNA improves cognitive function in middleaged and older adults with subjective memory complaints.
Method: This 12-week randomized, double-blind, placebo-controlled trial enrolled 80 adults aged 55-79 years with subjective memory complaints and MMSE-J ≥ 24. Participants received Test food or Placebo once daily. The primary outcome was cognitive function assessed by Cognitrax. Secondary/exploratory outcomes included bowel habits, biochemical parameters, and safety. Efficacy was evaluated in the per-protocol set (n=74), and safety was evaluated in the full analysis set (n=80). An exploratory subgroup comprised participants aged ≥ 65 years with baseline MMSE-J scores of 24-27.
Results: Overall, no consistent between-group differences were observed in memory-related Cognitrax outcomes, but Symbol Digit Coding correct responses improved significantly in the Test food group. In the exploratory subgroup, Verbal Memory and Verbal Memory delayed correct hits improved significantly, whereas Symbol Digit Coding errors decreased significantly, versus Placebo. Bowel habit indices did not improve. Exploratory analyses suggested favorable changes in fasting glucose, HbA1c, gamma-glutamyl transferase (γ-GT), and uric acid. No serious adverse events or product-related side effects occurred.
Conclusion: The Test food did not show consistent overall memory-related benefit, but improved an attentionrelated index and, in a cognitively high-risk subgroup, improved verbal memory-related outcomes while an attention-related subtest score decreased. Together with unchanged bowel indices and favorable exploratory changes in selected metabolic markers, these findings suggest that metabolic changes may be involved, at least in part, in the observed cognitive effects.

Keywords: C lostridium butyricum; HMPA; salmon milt-derived DNA; cognitive function; gut-brain axis; randomized controlled trial

Shinryo to Shinyaku （Med Cons New-Remed）2026；63（6）：369-385

Effects of a Capsule Containing Clostridium butyricum, 3-(4-Hydroxy-3-methoxyphenyl) propionic Acid, and Salmon Milt-Derived DNA on Cognitive Function in Middle-Aged and Older Adults: A 12-Week Randomized, Double-Blind, Placebo-Controlled Trial

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