Healthy male/female adults
Conditions
Interventions
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).
Sponsors
CPCC Company Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Japanese male/female subjects having an age of not less than 50 years old at informed consent. (2) Subjects fully realized that the subjects themselves must be in the failure of their cognitive function. (3) Subjects having a MMSE-J score of not less than twenty-four, at the pre-test. (4) Subjects having a positive efficacy index about continuous attention on Cognitrax, at the pre-test. (5) Subjects who can receive the test food once a week and put it in freezing storage. (6) Subjects who can take the test food for a meal once a day. (7) Subjects who can give informed consent to partake in this research, after being provided with an explanation of the protocol detail.
Exclusion criteria
Exclusion 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 - - .
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cognitive function test ( Cognitrax: a cognition item) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Questionnaire concerning Quality of Life (World Health Organization: QOL26) 2. Cognitive function test (Cognitrax: the other items) | — |
Countries
Japan
Contacts
Public ContactMakoto Ichinohe
CPCC Company Limited Clinical Planning Department
Outcome results
None listed