Blood Pressure, Cardiovascular Risk Factor, Lipid Profile
Conditions
Keywords
Barberry, Berberis vulgaris, Blood pressure, Lipids, Inflammation
Brief summary
The aim of this study is to investigate the effect of barberry consumption on systolic and diastolic blood pressure, serum lipids, and inflammatory status. The study will involve cases having elevated BP (129/ \< 85) and known hypertensive patients on medical treatment. Seventy people will be randomized into two groups, including intervention (barberry) or placebo groups. Before and after of 8 week intervention, 24-hour ambulatory blood pressure monitoring will be done and fasting venous blood sample will be taken to measure plasma lipids. In addition, 24-hour urine will be collected to measure its sodium content and estimate sodium intake.
Interventions
DIETARY_SUPPLEMENTberberis vulgaris=barberry
10 grams of barberry powder will be consumed daily for 8 weeks.
DIETARY_SUPPLEMENTPlacebo
Placebo powder
Sponsors
Shahid Beheshti University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* willingness to participate in the study * age between 20-65 years * having elevated BP (129/ \< 85) and known hypertensive patients on medical treatment * at least one other classical cardiovascular disease risk factors, including hyperlipidemia or diabetes mellitus
Exclusion criteria
* Unwillingness to continue participation * BMI\> 30 * patients on nitrates * high doses of statins consumption (Atorvastatin\>40 mg/day or Rosuvastatin\>20 mg/day) * consumption of vitamins or minerals supplements during past month * Chronic kidney disease stage 4 or 5
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| blood pressure | at 8 weeks | mean of systolic and diastolic blood pressure of participants measured by ambulatory 24 hour blood pressure monitoring |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| lipid profile | at 8 weeks | plasma TC, LDL-C, HDL-C, TG |
| plasma NOx | at 8 weeks | concentration of nitrite and nitrate in plasma |
| Inflammatory cytokine | at 8 weeks | Plasma Interleukin-6 |
Countries
Iran
Outcome results
None listed