Healthy volunteers Hypertension
Conditions
Interventions
Subjects receive 18 g of prune concentrate 3 times per day for 12 weeks.
Subjects receive 18 g of placebo 3 times per day for 12 weeks.
Sponsors
Hiroshima University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: High-normal blood pressure or grade I hypertension
Exclusion criteria
Exclusion criteria: 1) Taking medicines or receiving health guidance for hypertension, diabetes, and/or hyperlipidemia 2) Taking drugs or functional food that may affect the trial 3) Participation in any clinical trial within 90 days of the commencement of the trial 4) Fruit allergy 5) In pregnancy or nursing a child 6) Cardiac, renal, and/or hepatic dysfunction 7) History of severe disease and/or major surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Systolic blood pressure and diastolic blood pressure at baseline, 6 and 12 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| FMD (flow mediated dilation), NOx, ADMA (asymmetric dimethylarginine), platelet aggregation test, thromboxane B2, urinary 8-isoprostane, MDA (malondialdehyde), urinary 8-OHdG (8-hydroxydeoxyguanosine), BAP (biological antioxident potential) test, high-sensitivity CRP, and intestinal flora (T-RFLP), at baseline and 12 weeks. | — |
Countries
Japan
Contacts
Public ContactFumiko Higashikawa
Hiroshima University, Institute of Biomedical & Health Sciences Project Research Center for Clinical Trial and Preventive Medicine
Outcome results
None listed