Community-dwelling elderly people
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: [1]Males and females aged more than 65 years. [2]Individuals whose written informed consent has been obtained.
Exclusion criteria
Exclusion criteria: [1]Individuals who have a history of mental or cerebrovascular diseases. [2]Individuals who use medicines which may affect central nerve. [3]Individuals who regularly visit otorhinolaryngology. [4]Individuals who regularly intake supplements or healthy foods which may affect cognitive function. [5]Individuals who regularly intake medicines for pollen allergy. [6]Individuals whose score of MMSE test at screening are below 26. [7]Individuals who have allergy of milk, wheat or dried bonito flakes. [8]Individuals judged inappropriate by blood test at screening. [9]Individuals who have a history of drug or alcohol dependence. [10]Individuals who participate or will participate clinical studies. [11]Individuals judged inappropriate for the trial by the principal.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cognitive function [1]Word fluency test, [2]TMT-A,B ([1]~[2] Before and after 12-week ingestion) | — |
Secondary
| Measure | Time frame |
|---|---|
| *Secondary outcomes [1]WHO-5, [2]Olfactory identification test, [3]Questionnaire about diet and mood ([1]~[3] Before and 12-week ingestion) *Safety [1]Doctor's questions [2]Body weight (BMI) [3]Blood pressure and pulse rate [4]Blood test, blood biochemical test, and urine analysis ([1]~[3] Before and after 12-week ingestion, [4]Screening and after 12-week ingestion) *Other indexes [1]Doctor's questions [2]Body height and weight (BMI) [3]Blood pressure and pulse rate [4]Blood test, blood biochemical test, and urine analysis [5]MMSE test [6]Subject's diary ([1]~[5]Screening, [6]During 12-week ingestion) | — |
Countries
Japan
Contacts
KSO Corporation Chairman & CEO