Berberis Vulgaris Consumption and Blood Pressure

Study Overview
=================
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.

Official Title
-----------------
Effect of Berberis Vulgaris Consumption on Blood Pressure and Plasma Lipids in Subjects With Cardiovascular Risk Factors

Conditions
-----------------
Blood Pressure, Cardiovascular Risk Factor, Lipid Profile

Intervention / Treatment
-----------------
* Dietary Supplement: berberis vulgaris=barberry
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Barberry<br>Daily consumption of barberry in powder form. | Dietary Supplement: berberis vulgaris=barberry<br>* 10 grams of barberry powder will be consumed daily for 8 weeks.<br>|
| Placebo Comparator: placebo<br>Daily consumption of placebo powder. | Dietary Supplement: Placebo<br>* Placebo powder<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood pressure | mean of systolic and diastolic blood pressure of participants measured by ambulatory 24 hour blood pressure monitoring | at 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| lipid profile | plasma TC, LDL-C, HDL-C, TG | at 8 weeks | 
| plasma NOx | concentration of nitrite and nitrate in plasma | at 8 weeks | 
| Inflammatory cytokine | Plasma Interleukin-6 | at 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Barberry, Berberis vulgaris, Blood pressure, Lipids, Inflammation