Healthy Japanese subjects
Conditions
Interventions
Duration: Test food: Tanjinhokoujun Administration: Take four tablets with water at any time during the day *Daily dose should be taken within the day. If you forget to take the test food, take
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 subjects 5. Subjects whose FMD values are more than 6% at screening (before consumption: Scr) 6. Subjects whose FMD values are relatively low at 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 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. Subjects who use or take "Foods for Specified Health Uses," or "Foods with Functional Claims" in daily 5. Subjects who currently taking medications (including herbal medicines) and supplements 6. Subjects who are allergic to medicines and/or the test food related products 7. Subjects who are pregnant, lactation, or planning to become pregnant 8. Subjects who suffer from COVID-19 9. 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 10. Subjects who are judged as ineligible to participate in the study by the physician 11. Subjects who take food/beverage containing functional ingredients which may influence blood vessel function (such as procyanidins, lactotripeptide, black soybean polyphenols, and elastin peptides) in daily 12. Subjects who have bleeding disorder 13. Subjects who are currently undergoing treatment for hypotension 14. Subjects who plan to have surgery within two weeks after this trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Flow mediated dilation (FMD) at 12 weeks after the consumption (12w) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. FMD at four and eight weeks after the consumption (4w, 8w) 2. Maximum expansion width of the blood vessel*, the resting vessel diameter, systolic blood pressure, diastolic blood pressure, total cholesterol, high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, and triglyceride (TG) at 4w, 8w, and 12w *Maximum expansion width of the blood vessel = the maximum dilated vessel diameter - the resting vessel diameter | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed