Validation research of improvement effects on cognition by test-food intakes

UMIN ID: UMIN000050693

Registered date:03/04/2024

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Healthy male/female adults
• Date of first enrollment: 2023/04/03
• Target sample size: 76
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Ingestion of the test food to the subjects, one a day (at breakfast, lunch or dinner).
Ingestion of the placebo food to the subjects, one a day (at breakfast, lunch or dinner).

Outcome(s)

• Primary Outcome: Cognitive function test ( Cognitrax: a cognition item)
• Secondary Outcome: 1. Questionnaire concerning Quality of Life (World Health Organization: QOL26) 2. Cognitive function test (Cognitrax: the other items)

Key inclusion & exclusion criteria

• Age minimum: 50years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: Subjects - - (1) who take steadily (not less than four times a week) in medicines (e.g., herbal), foods (e.g., bluefish) and supplements (e.g., DHA, EPA), which might affect human cognitive functions, (2) who have used (not less than four times a week) an affecting apparatus/application, (3) suffering from dementia, (4) with previous and/or current medical history of mental diseases (e.g., depression), (5) diagnosed as attention deficit hyperactivity disorder, (6) with color deficiency, (7) being under the restriction of carbohydrate with dieting, (8) with extremely irregular eating habits, (9) restricting their mealtimes to no more than once a day (not less than once a week), within the last month, (10) with excessive alcohol intake, (11) having a habit of smoking, (12) planning to vaccinate after the pre-test to the hospital visiting (12 W), (13) who will be under a variable condition, such as dietary habits, house-moving, transfer, (14) whose roomer will partake in this research, (15) being severe anemic, (16) with significant changes of their menopausal physical condition, (17) being under another clinical test with medicine or health food, or partook in that within the past 4 weeks, or will partake in that after giving informed consent, (18) having previous/current medical history of severe cardiac, hepatic, renal or digestive diseases, (19) with pregnancy, possibly one, or lactating, (20) having drug and food allergy (especially to wheat, egg, milk and soybean), (21) who donated their blood components or blood (0.2 L) within the last month, (22) who donated his blood (0.4 L) within the past 3 months, (23) who donated her blood (0.4 L) within the past 4 months, (24) being collected in total of his blood (1.2 L) within the past 12 months and in this research, (25) being collected in total of her blood (0.8 L) within the past 12 months and in this research, (26) determined as ineligible for participation, judging from the principal/sub investigator - - .

Related Information

• Primary Sponsor: CPCC Company Limited
• Source(s) of Monetary Support: Nisshin Seifun Group Inc.