A verification study for improving cognitive function with consumption of the test food in healthy subjects aged 40 or more
- Conditions
- Healthy Japanese subjects
- Registration Number
- JPRN-UMIN000044919
- Lead Sponsor
- ORTHOMEDICO Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 24
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The measured value of the standardized score of visual memory at 12 weeks after consumption (12w)
- Secondary Outcome Measures
Name Time Method 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)