Volunteer
Conditions
Interventions
Sponsors
ORTHOMEDICO Inc.
Medical Corporation Seishinkai, Takara Clinic Nerima Medical Association, Minami-machi Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Japanese 2. Men or women 3. Adults 4. Healthy individuals 5. Individuals whose FMD is 4% or more and less than 7% at Scr 6. Individuals whose baPWV is less than 1.8 m/s at Scr
Exclusion criteria
Exclusion criteria: Individuals who/whose 1. are undergoing medical treatment or have a medical history of malignant tumor, heart failure, or myocardial infarction 2. have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. are currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, hemorrhagic disease, hypotension, or any other chronic diseases 4. are taking "Foods for Specified Health Uses" or "Foods with Functional Claims" 5. usually take foods or beverages that may affect the vascular endothelial function (such as procyanidins, lactotripeptide, black soybean polyphenols, elastin peptides) 6. are taking or using medications (including herbal medicines) or supplements 7. are allergic to medicines and foods related to the test product, particularly who show allergic reactions to citrus fruit 8. working form is irregular 9. engage in intense exercise 10. usually 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)} 11. are pregnant, lactating, or planning to become pregnant during this study 12. may undergo surgery during within the last two weeks before the agreement to participate in this study or within two weeks after the end of consumption 13. have been enrolled in other clinical studies within the last 28 days before the agreement to participate in this study or plan to participate in another study during this study 14. are judged as ineligible to participate in this study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The measured value of flow-mediated dilatation (FMD) at 8 weeks after intervention (8w) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The measured value of FMD at 4 weeks after intervention (4w) 2. The amount and percentage of change of FMD from screening (before consumption; Scr) to 4w and 8w 3. The measured values of maximum expansion width of the blood vessel, the resting vessel diameter, brachial ankle pulse wave velocity (baPWV), systolic blood pressure, diastolic blood pressure, interleukin-11 (IL-11), E-selectin and high sensitivity C-reactive protein (CRP) at 4w and 8w, and the amount and percentage of changes of them from Scr | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed