Healthy Japanese subjects
Conditions
Interventions
Duration: 12 weeks Test food: Tablet containing proanthocianidins derived from Acacia Bark Administration: 1. During test-food consumption: Take six tablets with water without chewing before meals
Sponsors
ORTHOMEDICO Inc.
Medical Corporation Seishinkai, Takara Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy Japanese adult subjects 2. Subjects who have relatively high levels of blood pressure, or being anxious about or suffering their blood pressure 3. Subjects who are judged as eligible to participate in the study by the physician 4. Subjects who are no more than 89 mmHg in diastolic blood pressure at screening (before test-food consumption) 5. Subjects who are between 130 mmHg or more and 139 mmHg or less in systolic 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. 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 have severe anemia 5. Subjects who have or are suspected of secondary hypertension 6. Subjects who drink alcoholic beverages or smoke cigars immoderately 7. Subjects who work late-night shift or are irregular of their life-styles 8. Subjects who have vigorous exercise habits 9. Subjects who use or take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage in daily 10. Currently taking medicines (include herbal medicines) and supplements 11. Subjects who are allergic to medicines and/or the test food related products 12. Subjects who are pregnant, breast-feeding, and planning to become pregnant 13. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial or plan to participate another trial during this trial 14. 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 ratio of the number of subjects who are less than 130 mmHg in SSBP and no more than 89 mmHg in sitting diastolic blood pressure (SDBP) at 12w 2. The measured values of SSBP at eight weeks after the start of test-food consumption (8w) 3. The measured values of SSBP at four weeks after the start of test-food consumption (4w) 4. The measured values of SSBP at the examination before test-food consumption (0w) 5. The change values of SSBP between at 0w and at 4w, 8w and 12w 6. The measured values of SDBP at 0w, 4w, 8w and 12w 7. The change values of SDBP between at 0w and at 4w, 8w and 12w 8. The measured value of superoxide dismutase (SOD) before cold water load and 30 min after cold water load at 0w, and the measured difference value* of SOD between before and 30 min after cold water load at 0w 9. The measured values of SOD before and 30 min after cold water load at 12w, and the measured difference value* of SOD between before and 30 min after cold water load at 12w 10. The change values of SOD before and 30 min after cold water load between at 0w and 12w, and the change difference value* of SOD between before and 30 min after cold water load between at 0w and 12w 11. The measured values of blood flow before and 30 min after cold water load at 0w and the measured difference value* of blood flow between before and 30 min after cold water load at 0w 12. The measured and change values of blood flow before and 30 min after cold water load at 12w and the measured difference value* of blood flow between before and 30 min after cold water load at 12w 13. The change values of blood flow before and 30 min after cold water load between at 0w and 12w and the measured difference value* of blood flow between before and 30 min after cold water load between at 0w and 12w *8-13 difference value = the value of blood flow at 30 min after cold water load - the value of blood flow before cold water load | — |
Countries
Japan
Contacts
Public ContactNaoko SUZUKI
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed