Healthy Japanese subjects
Conditions
Interventions
Duration: Four weeks Test food: Capsule containing lipid-soluble polyphenol Administration: Take five capsules per day after breakfast with water. *If you forget to take the test food, take it
Sponsors
ORTHOMEDICO Inc.
Medical Corporation Seishinkai, Takara Clinic Nerima Medical Association, Minami-machi Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy Japanese adult subjects 2. Subjects who are judged as eligible to participate in the study by the physician
Exclusion criteria
Exclusion criteria: 1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction 2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Currently undergoing treatment for any of the following chronic disease: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. Subjects who use or take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage in daily 5. Subjects currently regularly taking medications (including herbal medicines) and supplements 6. Subjects who are allergic to medicines and/or the test food related products 7. Subjects who are pregnant, breast-feeding, and planning to become pregnant 8. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial or plan to participate another trial during this trial 9. Subjects who are judged as ineligible to participate in the study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Incidence of side effects 2. Incidence of adverse events | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Physical examination 2. Urinalysis 3. Blood test 4. Original questionnaires 5. The measured values of the total score of self-administered dementia checklist (SDC), and the score of cognitive function and life function at two and four weeks after the start of test-food consumption 6. The change of the total score of SDC, and the score of cognitive function and life function at two and four weeks after the start of test-food consumption 7. The measured value of BDNF at four weeks after the start of test-food consumption 8. The change of BDNF at four weeks after the start of test-food consumption 9. The measured values of all of the total score of SDC at two and four weeks after the start of test-food consumption | — |
Countries
Japan
Contacts
Public ContactNaoko SUZUKI
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed