None listed
Conditions
Sponsors
KSO Corporation
TOYO SHINYAKU Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Males and females aged 60 to 79 years-old. 2)Subjects whose score of Mini Mental State Examination-Japanese (MMSE-J) is 24 or more at screening tests. 3)Subjects who are aware of forgetfulness or aware of memory decline and/or judgment decline. 4)Subjects who can make self-judgment and are voluntarily giving written informed consent.
Exclusion criteria
Exclusion criteria: Subjects (who) 1)have been determined by a physician to have dementia. 2)are taking or have taken drugs related to dementia. 3)have a history of and/or contract serious diabetes and/or cerebrovascular disease. 4)have contract serious diseases (e.g., liver disease, kidney disease, heart disease). 5)taking supplements that may improve cognitive function. 6)have a history and/or a surgical history of digestive disease affecting digestion and absorption. 7)are under treatment for or have a history of alcoholism. 8)have declared with food allergies. 9)can't stop drinking from a day before each measurement 10)have alcohol intake more than approximately 20 g/day of pure alcohol equivalent and a habit of drinking not less than 4 days a week. 11)with extremely irregular eating habits and rhythm of life. 12)suffering from depression or other psychiatric disorders. 13) have donated over 200 mL of blood and/or blood components within the last one month prior to the current study or over 400 mL of blood and/or blood components within the last three months prior to the current study. 14) are planning to participate and/or had participated in other clinical studies within the last one month prior to the current study. 15) are judged as unsuitable for the current study by the investigator for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cognitive function test score after 12 weeks consumption | — |
Secondary
| Measure | Time frame |
|---|---|
| QOL questionnaire after 12 weeks consumption | — |
Countries
Japan
Contacts
Public ContactYoshika Komori
KSO Corporation Clinical Trial Management department
Outcome results
None listed