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Effects of consumption of the test food on the cognitive function in middle-aged and older Japanese subjects

Effects of consumption of the test food on the cognitive function in middle-aged and older Japanese subjects: a randomized, placebo-controlled, double-blind, parallel-group comparison study - Effects of consumption of the test food on the cognitive function in middle-aged and older Japanese subjects

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000057063
Enrollment
84
Registered
2025-02-19
Start date
2025-02-20
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy middle-aged and older Japanese subjects

Interventions

Duration: 24 weeks Test food: Nucleotide containing capsule Administration: Take one capsule per day * Daily dose should be taken within the day. If you forget to take the test food, take it as

Sponsors

Tashikani Plus Co., Ltd
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Subjects with an MMSE score of 24 to 27 at screening and a Cognitrax standardized score of 60 to 90 for composite memory 2) Age: 50 years or older 3) Gender: Any 4) Non-smokers 5) Subjects who do not regularly consume foods designated for specified health uses, foods with functional claims, or other foods/drinks that may have functional properties 6) Subjects who do not consume foods or supplements that may affect cognitive function, such as DHA/EPA, ginkgo leaf extract, tocotrienol, astaxanthin, GABA, phosphatidylserine, plasmalogen, etc. 7) Subjects who do not consume blue fish such as sardines, mackerel, or pacific saury for more than 4 days a week 8) Subjects who do not use tools, equipment, apps, etc. that may affect cognitive function (e.g. brain training puzzles, brain training games, etc.) 9) Subjects who do not regularly use medicines (including herbal medicines) 10) Subjects who do not suffer from lifestyle-related diseases (diabetes, etc.), rheumatism, liver disorders, kidney disorders, or other chronic diseases. 11) Subjects who do not suffer from dementia. 12) Subjects who do not have irregular sleep hours or sleep habits due to night shifts, etc. 13) Subjects who do not have a history of mental illness such as depression or attention deficit hyperactivity disorder (ADHD). 14) Subjects who are currently undergoing treatment for or have a history of malignant tumors, heart failure, or myocardial infarction. 15) Subjects who do not have a pacemaker or implanted cardioverter defibrillator. 16) Subjects who have no history of allergies to medicines. 17) Subjects who are not visiting a hospital or taking medication for the purpose of treatment. 18) Subjects who fully understand the contents of the clinical trial and have given written consent.

Exclusion criteria

Exclusion criteria: 1) Pregnant or breastfeeding women or those who intend to become pregnant during the study period 2) Subjects who are participating in other clinical trials or studies, or those who have participated in other clinical trials or studies within the past 3 months 3) Subjects who are unable to follow the instructions of the doctor in charge or the medical institution staff 4) Subjects who are judged by the study administrator to have some kind of problem

Design outcomes

Primary

MeasureTime frame
Cognitrax

Secondary

MeasureTime frame
1.Quality of life(POMS2, OSA-MA) 2.Safety assessment (blood tests, adverse events)

Countries

Japan

Contacts

Public ContactTaisuke Fukaya

Tashikani Plus Co., Ltd CEO

fukaya@tashikani.jp06-6352-6622

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026