Healthy Japanese subjects
Conditions
Interventions
Duration: Eight weeks Test food: Test food A Administration: Dissolve one packet (4 g) with approximately 100 ml of water and drink it at a meal once daily *If you forget to take the test food, t
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 who have high systolic blood pressure 6. Subjects who are judged as eligible to participate in the study by the physician
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 currently undergoing treatment for any of the following chronic diseases: 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 are 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, lactating, or planning to become pregnant during this trial 8. Subjects who suffer from COVID-19 9. Subjects who are a smoker 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 this study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The measured values of systolic blood pressure at eight weeks after consumption (8w) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The measured values of diastolic blood pressure at 8w 2. The amount of changes from screening (before consumption; Scr) in systolic blood pressure at 8w 3. The amount of changes from Scr in diastolic blood pressure at 8w | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed