Healthy Japanese subjects
Conditions
Interventions
Duration: 12 weeks Follow-up duration: 4 weeks Test beverage: Lemon juice containing beverage Administration: Drink 30 mL of the test beverage per day at any time of the day
Duration: 12 weeks Fol
Sponsors
ORTHOMEDICO Inc.
Medical Corporation Seishinkai, Takara Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy Japanese adult subjects 2. Subjects who are judged as eligible to participate in the study by the physician 3. Subjects whose diastolic pressure is less than 90 mmHg at screening (before consumption) 4. Subjects whose systolic blood pressure is 130 mmHg or more and 139 mmHg or less at screening (before 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 diseases: cardiac arrhythmia, liver disease, kidney disease, gastrointestinal 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 to have 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 Function Claims", or other functional food/beverage in daily 10. Subjects who are currently taking medications (including herbal medicines) and supplements 11. Subjects who are allergic to citrus fruits 12. Subjects who are allergic to medicines and/or the test food related products 13. Subjects who are pregnant, lactation, or planning to become pregnant 14. 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 enroll in anther clinical trial during trial period 15. Subjects who are ineligibility to participate in the study based on the evaluation of the principal physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Systolic blood pressure * Assess the measured value at screening (before consumption), at 4, 8, and 12 weeks after consumption, and follow-up period for 4 weeks or calculate the amount of change. | — |
Secondary
| Measure | Time frame |
|---|---|
| Diastolic blood pressure * Assess the measured value at screening (before consumption), at 4, 8, and 12 weeks after consumption, and follow-up period for 4 weeks or calculate the amount of change. | — |
Countries
Japan
Contacts
Public ContactNaoko SUZUKI
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed