Healthy Japanese subjects
Conditions
Interventions
Duration: 12 weeks Test food: Food 1 (Low dose) Administration: Take two pieces per day
Duration: 12 weeks Test food: Food 2 (High dose) Administration: Take two pieces per day
Duration: 12 week
Sponsors
ORTHOMEDICO Inc.
Medical Corporation Seishinkai, Takara Clinic Nerima Medical Association, Minami-machi Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Japanese 2. Men or women 3. Subjects aged 40 or more 4. Healthy subjects 5. Subjects who are aware of the decline in their memory function 6. Subjects who are judged as eligible to participate in the study by the physician 7. Subjects whose scoring of Mini Mental State Examinination (MMSE)-J is 24 or more at Scr 8. Subjects who have a "yes" in the validity indicator of Cognitrax on both verbal memory and visual memory 9. Subjects who have a relatively low standardized score in visual memory by Cognitrax at Scr
Exclusion criteria
Exclusion criteria: Subjects (who) 1.have a history or current history of serious diseases of the heart, liver, kidneys, or digestive organs, or a history of major digestive system surgery such as gastrectomy, gastrointestinal suture, or intestinal resection 2.have a pacemaker or an implantable cardioverter defibrillator 3.are a treatment for chronic diseases 4.have significant abnormalities in blood pressure, physical and/or hematological data 5.have severe anemia 6.are pre- or post-menopausal women with severe physical changes 7.have dementia 8.have mental health issues 9.take medications and supplements 10.take supplements and/or foods related to improving cognitive functions, and/or take blue-backed fish at least 4 times a week 11.use devices, equipment, and applications that may affect cognitive functions at least 4 times a week 12.are allergies (particularly to wheat, eggs, milk, and soy) 13.are smoker 14.are heavy alcohol intake 15.with extremely irregular life rhythms 16.are on a carbohydrate restriction or diet, or who plan diet during the test period 17.have eaten less than one meal per day at least once a week for the past a month 18.may change their lifestyles during the test period 19.can't do the following actions: replace the main meal with test food at any 2 meals, receive the test food twice per week, and/or store test foods in frozen storage 20.are pregnant, breast-feeding, or planning to become pregnant 21.have been enrolled in other clinical trials within the last 4 weeks (wks) before the agreement to participate in this trial or plan to enroll in another clinical trial during trial period or within 4 wks after test period 22.donated blood before consuming the food (whole blood either 400 mL within 16 wks [women] or 12 wks [men], 200 mL within 4 wks [both], or blood components within 2 wks [both]) 23.are judged as ineligible to participate in the study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The measured value of the standardized score of visual memory at 12 weeks after consumption (12w) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The amount of change of the standardized score of composite memory between screening (before consumption; Scr) or start intake (0w) and 12w 2. The measured values and amounts of changes from Scr or 0w of the standardized score of other cognitive domains at 12w 3. The measured values and amounts of changes from 0w in each of the following items at 12w: physical component summary (PCS), mental component summary (MCS), role component summary (RCS), physical functioning, role physical, bodily pain, general health, activity, social functioning, role emotional, and mental health, brain derived neurotrophic factor (BDNF), Tumor Necrosis Factor-alpha (TNF-alpha), Interleukin-6 (IL-6), Biological Antioxidant Potential (BAP), d-Reactive Oxygen Metabolites (d-ROM) | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed