Berberis Vulgaris Consumption and Blood Pressure

October 23, 2020 updated by: Javad Nasrollahzadeh, Shahid Beheshti University

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

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

78

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Barberry
Daily consumption of barberry in powder form.
10 grams of barberry powder will be consumed daily for 8 weeks.
Placebo Comparator: placebo
Daily consumption of placebo powder.
Placebo powder

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 18, 2019

Primary Completion (Actual)

August 19, 2020

Study Completion (Actual)

October 21, 2020

Study Registration Dates

First Submitted

September 3, 2019

First Submitted That Met QC Criteria

September 7, 2019

First Posted (Actual)

September 10, 2019

Study Record Updates

Last Update Posted (Actual)

October 26, 2020

Last Update Submitted That Met QC Criteria

October 23, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • 895 (Other Grant/Funding Number: Allergan Pharmaceutical)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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