Effects of consumption of the test food on blood pressure
- Conditions
- Healthy Japanese subjects
- Registration Number
- JPRN-UMIN000050671
- Lead Sponsor
- ORTHOMEDICO Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 32
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 use or take "Foods for Specified Health Uses," or "Foods with Functional Claims" in daily 5. Subjects who usually take health foods containing ingredients which may influence blood pressure 6. Subjects who are currently taking medications (including herbal medicines) and supplements 7. Subjects who are allergic to medicines and/or the test food related products 8. Subjects who are a smoker 9. Subjects whose daily alcohol intake exceeds 20 g 10. Subjects who are pregnant, lactating, or planning to become pregnant during this trial 11. Subjects who suffer from COVID-19 12. 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 13. 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 measured value of systolic blood pressure at 12 weeks after consumption (12w)
- Secondary Outcome Measures
Name Time Method 1. The amount of changes in systolic blood pressure between screening (before consumption; Scr) and 12w 2. The measured values of diastolic blood pressure, flow-mediated dilation (FMD), maximum expansion width of the blood vessel, and the resting vessel diameter at 12w, and the amount of changes from Scr