Healthy subjects
Conditions
Sponsors
HUMA R&D CORP
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Japanese male and female aged over 40 at the time of the informed consent. 2)Subject who is aware of cognitive decline. 3)Subject who is able to take the test food daily for 12 weeks. 4)Subject with an MMSE score of 24 or more. 5)Subject who has understood the purpose of the study, and agreed to participate it by signing the written informed consent.
Exclusion criteria
Exclusion criteria: 1)Subject who is taking medication or under medical treatment. 2)Subject who is under exercise therapy or dietetic therapy. 3)Subject who has an allergy for test food. 4)Subject who has or had a history of either medicine or alcohol dependence syndrome. 5)Subject who has or had a history of mental illness (depression) or sleep disturbance. 6)Subject who is on a night-shift or is a shift worker. 7)Subject whose lifestyle is extremely irregular. 8)Subject who has an unbalanced diet. 9)Subject who is current disease or history of diabetes, liver disease (hepatitis), kidney disease, serious disease such as heart disease, thyroid disease, adrenal disease, other metabolic diseases. 10)Subject who is use health foods, supplements, and medicines(Icho-ha extract,DHA,EPA,Phosphatidylserine,lecithin etc) that may affect cognitive function. 11)Subject who has participated in other clinical studies within the past 3 months from the day of the consent acquisition or who is planning to participate in other clinical studies during the current study. 12)Subject who has blood drawn 200mL within the past 1 months or 400mL within the past 3 months from the day of the consent acquisition. 13)Subject who is planning to get pregnant after the day of informed consent or is currently pregnant and lactating. 14)Subject who can't keep the daily records. 15)Subject who is judged as an inappropriate candidate according to the screening data. 16)Subject who is considered as an inappropriate candidate by the doctor in charge.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cognitrax Repeatable Battery for the Assessment of Neuropsychological Status | — |
Secondary
| Measure | Time frame |
|---|---|
| SF-36 Physical examination hematologic test blood biochemical test Urine analysis Adverse event | — |
Countries
Japan
Contacts
Public ContactDaisuke Ochitani
HUMA R&D CORP Clinical Development Division
Outcome results
None listed