Healthy Japanese subjects
Conditions
Interventions
Duration: Eight weeks Test food: Supplements containing ginkgo leaf extract Administration: Take two capsules per day at breakfast with water *If you forget to take the test food, take it as soon a
Sponsors
ORTHOMEDICO Inc.
Medical Corporation Seishinkai, Takara Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy Japanese adult subjects 2. Subjects who feel memory loss 3. Subjects who are judged as eligible to participate in the study by the physician 4. Subjects who have 24 points or more of MMSE 5. Subjects who has relatively low standardized score in composite memory by Cognitrax
Exclusion criteria
Exclusion criteria: 1. At least one previous medical history of malignant tumor, heart failure or myocardial infarction 2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Currently under the treatment for either cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension or other chronic diseases 4. Subjects who have dementia 5. Subjects who have mental health issues such as depression disorder, attention deficit/hyperactivity disorder (ADHD), or other issues 6. Subjects who use or take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage in daily 7. Subjects who take supplements related to improving cognitive functions, such as docosahexaenoic acid (DHA), eicosapentaenoic acid (EPA), ginkgo leaf extract, tocotrienol, astaxanthin, gamma-aminobutyric acid (GABA), phosphatidylserine, and plasmalogen in daily 8. Subjects who take blue-backed fish such as sardines, mackerel, and saury in daily 9. Currently taking medicines (include herbal medicines) and supplements 10. Subjects who are allergic to medicines and/or the test food related products 11. Subjects who are pregnant, breast-feeding, and plan to become a pregnant during the study period or in the future, or wish for their own child 12. 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 enroll in anther clinical trial during trial period 13. Subjects who are judged as ineligible to participate in the study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The measured values of composite memory of Cognitrax at eight weeks after consumption | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The amount of change for composite memory of Cognitrax between screening (before consumption) and eight weeks after consumption 2. The measured values of each item excluding composite memory of Cognitrax at eight weeks after consumption 3. The amount of change for each item excluding composite memory of Cognitrax between screening (before consumption) and eight weeks after consumption 4. The measured values of each score and question items of POMS2 at eight weeks after consumption 5. The amount of change for each score and question items of POMS2 between screening (before consumption) and eight weeks after consumption 6. The measured values of each factor and items of OSA-MA at eight weeks after consumption 7. The amount of change for each factor and items of OSA-MA between screening (before consumption) and eight weeks after consumption 8. The measured values of original questionnaires (The Likert scale method) at eight weeks after consumption | — |
Countries
Japan
Contacts
Public ContactNaoko SUZUKI
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed