A verification study of the improving effects of the test food consumption on cognitive functio
- Conditions
- Healthy Japanese subjects
- Registration Number
- JPRN-UMIN000051045
- Lead Sponsor
- ORTHOMEDICO Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 56
Not provided
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. Subjects currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any 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," or "Foods with Functional Claims" in daily 7. Subjects who are currently taking medications (including herbal medicines) and supplements 8. Subjects who usually use devices, equipment, and applications that may affect cognitive functions (e.g., brain training puzzles, brain training games) 9. Subjects who are allergic to medicines and/or the test food related products 10. Subjects who are pregnant, lactating, or planning to become pregnant during this trial 11. Subjects who have been enrolled in other clinical trials within the last 28 days before the agreement to participate in this trial or plan to participate another trial during this trial 12. Subjects who are judged as ineligible to participate in this study by the physician
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. The standardized score of composite memory at 12 weeks after consumption (12w)
- Secondary Outcome Measures
Name Time Method 1. The standardized scores of each cognitive domain {neurocognition index (NCI), verbal memory, visual memory, psychomotor speed, reaction time, complex attention, cognitive flexibility, processing speed, executive function, social acuity, reasoning, working memory, sustained attention, simple attention and motor speed} at 12w