Evaluation of cognitive function by continuous intake of food containing fermented soybean extract
- Conditions
- Healthy subjects
- Registration Number
- JPRN-UMIN000043602
- Lead Sponsor
- HUMA R&D CORP
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 60
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cognitrax
- Secondary Outcome Measures
Name Time Method (Secondary outcomes) Subjective symptoms questionnaire (Safety evaluation) Vital signs,Body Measurement Values,Biochemistry,Hematology,Urinalysis,Adverse events