Healthy elderly adults with poor cognitive performance, MCI
Conditions
Interventions
Ingestion of functional food for 12 weeks
Ingestion of placebo for 12 weeks
Sponsors
KSO Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Japanese men and women aged greater than or equal to 40 years, less than 80 years at the time of obtaining informed consent. 2. Subjects with MMSE score of 24 to 29 at screening. 3. Subjects who have subjective forgetfulness or have been pointed out forgetfulness by others. 4. Subjects who got adequate explanation about the purpose and details of the examination, have the capacity to consent, voluntarily participate in understanding, and agree to participate in the examination in writing.
Exclusion criteria
Exclusion criteria: 1. Subjects who judged by a doctor as dementia. 2. Subjects who have taken or had taken drugs of dementia. 3. Subjects who regularly take drugs that may affect cognitive functions. 4. Subjects who have current medical history or past medical history of mental disorders (including depressive symptoms) or cerebrovascular diseases. 5. Subjects who regularly use supplements or health foods that may affect cognitive functions. 6. Subjects who judged inappropriate as subjects as a result of clinical examination of screening. 7. Subjects with gerontological depression scale (GDS-S-J) scores of 6 or more. 8. Subjects who have history of alcohol dependence or current medical history. 9. Subjects who consume a large amount of alcohol routinely. 10. Subjects who have serious illness or medical history such as diabetes, liver disease, kidney disease, heart disease. 11. Subjects who have medical history or history of food allergies or current medical history. 12. Subjects who have color vision disorder and can not easily hear people's talk at short distance. 13. Subjects who have problems with the functions of both hands due to injury, surgery, etc. 14. Subjects who are planning to participate and/or had participated in other clinical studies within the last one month prior to the current study. 15. Subjects who are judged as unsuitable for the current study by the investigator for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cognitrax | — |
Secondary
| Measure | Time frame |
|---|---|
| Various cognitive function tests and questionnaires, blood and urine tests | — |
Countries
Japan
Contacts
Public ContactYoshika Komori
KSO Corporation Sales department
Outcome results
None listed