Verification of the effects of test food on cognitive function

UMIN ID: UMIN000054058

Registered date:07/04/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Healthy adults
• Date of first enrollment: 2024/05/27
• Target sample size: 60
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

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

Outcome(s)

• Primary Outcome: Cognitive test Memory test
• Secondary Outcome: 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

Key inclusion & exclusion criteria

• Age minimum: 50years-old
• Age maximum: 79years-old
• Gender: Male and Female
• Exclude 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

Related Information

• Primary Sponsor: Miura Clinic, Medical Corporation Kanonkai
• Source(s) of Monetary Support: TOWA PHARMACEUTICAL CO.,LTD