Healthy Japanese subjects
Conditions
Interventions
Duration: 12 weeks Test food: Capsules containing concentrated black vinegar powder Administration: Take one capsule per day with water *Take the test food immediately after the first blood pres
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. Subjects aged 20 or more 4. Healthy subjects 5. Subjects who are judged as eligible to participate in the study by the physician 6. Subjects who are negative or pseudopositive urine occult blood (menstruating women can be included even if they are positive.) 7. Subjects who are between 130 mmHg or more and 139 mmHg or less in systolic blood pressure at screening (before test-food consumption) 8. Subjects who are no more than 89 mmHg in diastolic blood pressure at screening (before test-food consumption)
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 take "Foods for Specified Health Uses," "Foods with Functional Claims," or other functional food/beverage in daily use 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 suffer from coronavirus disease 2019 (COVID-19) 8. Subjects who are smokers 9. Subjects who are pregnant, lactation, or planning to become pregnant 10. 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 11. Subjects who are judged as ineligible to participate in the study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The measured value of sitting systolic blood pressure (SSBP) at 12 weeks after the start of test-food consumption (12w) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The measured values of SSBP at four and eight weeks after consumption (4w, 8w) 2. The measured values of sitting diastolic blood pressure (SDBP) at 4w, 8w and 12w 3. The ratio of number of subjects who are SSBP 129 mmHg or less and SDBP 89 mmHg or less at 12w 4. The measured values of SSBP, SDBP and Total Area Under the Curve (tAUC) at before consumption and each subsequent measurement points (30, 60, 90, 120, 150 180 minutes after taking the test food) | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed