Berberis Vulgaris Consumption and Blood Pressure

Blood Pressure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04084847
• Other study ID #: 895
• Status: Completed
• Phase: N/A
• Start date: September 18, 2019
• Est. completion date: October 21, 2020

Study information

• Verified date: October 2020
• Source: Shahid Beheshti University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: October 21, 2020
• Est. primary completion date: August 19, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Blood Pressure
• Cardiovascular Risk Factor
• Lipid Profile

Intervention

Dietary Supplement:
• berberis vulgaris=barberry
10 grams of barberry powder will be consumed daily for 8 weeks.
• Placebo
Placebo powder

Locations

Country	Name	City	State
Iran, Islamic Republic of	Rajaei Cardiovascular, Medical & Research Center	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Shahid Beheshti University

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	blood pressure	mean of systolic and diastolic blood pressure of participants measured by ambulatory 24 hour blood pressure monitoring	at 8 weeks
Secondary	lipid profile	plasma TC, LDL-C, HDL-C, TG	at 8 weeks
Secondary	plasma NOx	concentration of nitrite and nitrate in plasma	at 8 weeks
Secondary	Inflammatory cytokine	Plasma Interleukin-6	at 8 weeks