Healthy subjects
Conditions
Sponsors
HUMA R&D CORP
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Japanese men and women aged between 40 and 65 at the time of obtaining written informed consent. 2.Subject who is aware of the decline in cognitive function. 3.Subject who has a MMSE-J score of 24 points or more. 4.Non-smoker. 5.Subject who has received sufficient explanation of the purpose and content of the research, have the ability to consent, voluntarily volunteered to participate in the study after understanding it well, and agreed to participate in the study in writing.
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 may develop allergies due to the test foods. 4.Subject with current or history of drug dependence or alcohol dependence. 5.Subject who is out of the hospital due to mental disorders (depression, etc.) or sleep disorders, or who have a history of mental illness in the past. 6.Subject with irregular life rhythms due to night shifts or shift work. 7.Subject with extremely irregular lifestyle habits such as eating and sleeping. 8.Subject who has an extremely unbalanced diet. 9.Serious diseases such as brain disease, malignant tumor, immune disease, diabetes, liver disease (hepatitis), renal disease, heart disease, thyroid disease, adrenal disease, and other serious current or past diseases such as metabolic disease those who have. 10.Subject who uses health foods, supplements(Ginkgo biloba extract, DHA, EPA, plasmaprogen, phosphatidylserine, etc.), and medicines that have an affect cognitive function. 11.Subject who has participated in other clinical trials (research) within 3 months from the date of consent acquisition or who plans to participate in other clinical trials (research) during the trial period. 12.Subject who has collected 200 mL of blood or donated more than 400 mL of blood within 3 months from the date of 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 has difficulty observing records on various survey forms. 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| (Secondary outcomes) Subjective symptoms questionnaire (Safety evaluation) Vital signs,Body Measurement Values,Biochemistry,Hematology,Urinalysis,Adverse events | — |
Countries
Japan
Contacts
Public ContactDaisuke Ochitani
HUMA R&D CORP Clinical Development Division
Outcome results
None listed