Berberis Vulgaris Consumption and Blood Pressure

Not Applicable

Completed

• Conditions: Blood Pressure; Lipid Profile; Cardiovascular Risk Factor
• Interventions: Dietary Supplement: berberis vulgaris=barberry; Dietary Supplement: Placebo

• Registration Number: NCT04084847
• Lead Sponsor: Shahid Beheshti University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-09-03
• Study First Submitted QC: 2019-09-07
• Study First Posted: 2019-09-10
• Study Start: 2019-09-18
• Primary Completion: 2020-08-19
• Status Verified: 2020-10
• Study Completion: 2020-10-21
• Last Update Submitted: 2020-10-23
• Last Update Posted: 2020-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Barberry	berberis vulgaris=barberry	Daily consumption of barberry in powder form.
placebo	Placebo	Daily consumption of placebo powder.

Primary Outcome Measures

Name	Time	Method
blood pressure	at 8 weeks	mean of systolic and diastolic blood pressure of participants measured by ambulatory 24 hour blood pressure monitoring

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Rajaei Cardiovascular, Medical & Research Center; 🇮🇷 Tehran, Iran, Islamic Republic of