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Verification of the effects of test food on cognitive function

Verification of the effects of test food on cognitive function : Placebo-controlled, double-blind, randomized, two-phase, cross-over comparison study - Verification of the effects of test food on cognitive function : Placebo-controlled, double-blind, randomized, two-phase, cross-over comparison study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000054058
Enrollment
60
Registered
2024-04-07
Start date
2024-05-27
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 adults

Interventions

Ingestion the test food for 24 weeks Ingestion the placebo food for 24 weeks

Sponsors

Miura Clinic, Medical Corporation Kanonkai
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Subjects of men and women aged 50 to 79 (2) Subjects who are aware of memory loss (3) Subjects with a MoCA-J score of 26 or higher (4) Subjects who received sufficient explanation about the purpose and content of the test, had the ability to consent, voluntarily volunteered to participate after understanding it well, and agreed to participate in the test in writing.

Exclusion criteria

Exclusion criteria: (1) Subjects with Alzheimer's disease (2) Subjects with a history of stroke, subarachnoid hemorrhage, cerebral infarction, cerebral hemorrhage, cerebral contusion, or head injury (3) Subjects with a history of diabetes, liver diseases, renal disease, gastrointestinal disease, cardiac disease, respiratory disease, peripheral vascular disease, or other serious disease. (4) Subjects who have undergone gastrointestinal surgery (5) Subjects with abnormal liver and renal function test value (6) Subjects with diseases currently being treated (7) Subjects who are allergic to food and drugs (8) Subjects with anemia symptoms (9) Subjects with color discrimination difficulties (10) Subjects who have difficulty performing cognitive function tests due to low visual acuity, or who have been diagnosed with low vision or blindness (11) Subjects who have depression or have been diagnosed with depression (12) Subjects with motor, visual or hearing impairments (13) Subjects who play intense sports and subjects who are on a diet (14) Subjects who work at night or have other irregularities in their daily life during the examination period (15) Subjects who cannot stop taking health foods (including foods for specified health use and foods with functional claims) and quasi-drugs during the test period (16) Subjects who are continuously treated with pharmaceuticals (including OTC and prescription drugs) (17) Subjects who drink more than 20 g of average daily pure alcohol (18) Subjects who are participating in or will participate in other clinical trials at the start of this study. (19) Other subjects judged by the investigator or the investigator to be inappropriate for the examination

Design outcomes

Primary

MeasureTime frame
Cognitive test Memory test

Secondary

MeasureTime frame
Plasma amyloid beta 1-40 Plasma amyloid beta 1-42 Plasma amyloid beta 1-42/1-40 ratio glycoalbumin 1, 5-anhydro-D-glucitol Urinary 8-OHdG Subjective Indicator Survey

Countries

Japan

Contacts

Public ContactMakoto Terashima

Oneness Support Co., Ltd. Clinical Trial Division

mterashima@oneness-sup.co.jp06-4801-8917

Outcome results

None listed

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