Effects of consumption of the test food on blood vessels
- Conditions
- Healthy Japanese subjects
- Registration Number
- JPRN-UMIN000046054
- Lead Sponsor
- ORTHOMEDICO Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 66
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 who currently under the treatment for either cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, hypotension, hemorrhagic disease, or other chronic diseases 4. Subjects who take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage in daily use 5. Subjects whose BMI is 30 kg/m2 or more 6. Subjects currently taking medicines (include herbal medicines) and supplements 7. Subjects who are allergic to medications and/or the test-food-related products (particularly citrus fruit) 8. Subjects who plan to have surgery 9. Subjects who are pregnant, breast-feeding, and planning to become pregnant 10. Subjects who suffer from COVID-19 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 the study by the physician
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Flow mediated dilation (FMD) at eight weeks after the consumption (8w)
- Secondary Outcome Measures
Name Time Method 1. FMD at four weeks after the consumption (4w) 2. Maximum expansion width of the blood vessel*, the resting vessel diameter, baPWV (brachial-ankle pulse wave velocity), blood flow volume, vascular age, high sensitivity C-reactive protein, sVCAM-1 (vascular cell adhesion molecule 1, soluble), and E-selectin at 4w and 8w *Value obtained by subtracting the resting vessel diameter from the maximum dilated vessel diameter