Healthy Japanese subjects
Conditions
Interventions
Duration: Eight weeks Test food: Active tablet 1 Administration: Take two tablets with water once a day before breakfast or when you are hungry *On the day of visiting the clinic (4w and 8w), tak
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. Male or female 3. Subjects aged 20 or more 4. Healthy subjects 5. Subjects whose BMI (body mass index) is relatively high 6. Subjects who are judged as eligible to participate in the study by the physician 7. Subjects whose FMD values are relatively low at screening (before consumption: Scr)
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Flow mediated dilation (FMD) at eight weeks after the consumption (8w) | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed