Effects of consumption of the test food on the cognitive function in healthy Japanese subjects: an open-label trial
- Conditions
- Healthy Japanese subjects
- Registration Number
- JPRN-UMIN000048134
- Lead Sponsor
- ORTHOMEDICO Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 18
Not provided
Subjects (who) 1.are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction 2.have a pacemaker or an implantable cardioverter defibrillator 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.use or take "Foods for Specified Health Uses," or "Foods with Functional Claims" in daily 5.currently taking medications (including herbal medicines) and supplements 6.are allergic to medicines and/or the test food related products 7.are pregnant, lactation, or planning to become pregnant 8.suffer from COVID-19 9.have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial or plan to participate in another trial during this trial 10.are judged as ineligible to participate in the study by the physician 11.have irregular working hours 12.have irregular ifestyles (such as diet, exercise, and sleep) 13.live with requiring long-term care persons 14.drink to excess (average of more than about 20 g/day as absolute alcohol intake) {500 mL: a medium bottle of beer or about 1.5 cans of canned chu-hi, 180 mL: 1 go of sake or about 1.5 glasses of wine, 90 mL: half-go with shochu, 60 mL: a glass of whiskey brandy (double)} 15.take food/beverage containing functional ingredients which may influence cognitive function or vessel function 16.have dementia 17.have mental health issues such as depression disorder, attention deficit/hyperactivity disorder, or other issues 18.are smokers 19.currently undergoing treatment for hemorrhagic disease, hypotension, thrombocytopenia, convulsive disorder, bradycardia, pulmonary disease, gastrointestinal tract obstruction, peptic ulcer, hyperthyroidism, or urogenital obstruction 20.plan to have surgery within two weeks after this trial
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method