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Berberis Vulgaris Consumption and Blood Pressure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04084847
Recruitment Status : Completed
First Posted : September 10, 2019
Last Update Posted : October 26, 2020
Sponsor:
Information provided by (Responsible Party):
Javad Nasrollahzadeh, Shahid Beheshti University of Medical Sciences

Study Description
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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.


Condition or disease Intervention/treatment Phase
Blood Pressure Cardiovascular Risk Factor Lipid Profile Dietary Supplement: berberis vulgaris=barberry Dietary Supplement: Placebo Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Effect of Berberis Vulgaris Consumption on Blood Pressure and Plasma Lipids in Subjects With Cardiovascular Risk Factors
Actual Study Start Date : September 18, 2019
Actual Primary Completion Date : August 19, 2020
Actual Study Completion Date : October 21, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Barberry
Daily consumption of barberry in powder form.
 Dietary Supplement: berberis vulgaris=barberry
10 grams of barberry powder will be consumed daily for 8 weeks.
Placebo Comparator: placebo
Daily consumption of placebo powder.
 Dietary Supplement: Placebo
Placebo powder


Outcome Measures
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Primary Outcome Measures :
  1. blood pressure [ Time Frame: at 8 weeks ]
    mean of systolic and diastolic blood pressure of participants measured by ambulatory 24 hour blood pressure monitoring


Secondary Outcome Measures :
  1. lipid profile [ Time Frame: at 8 weeks ]
    plasma TC, LDL-C, HDL-C, TG

  2. plasma NOx [ Time Frame: at 8 weeks ]
    concentration of nitrite and nitrate in plasma

  3. Inflammatory cytokine [ Time Frame: at 8 weeks ]
    Plasma Interleukin-6


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04084847


Locations
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Iran, Islamic Republic of
Rajaei Cardiovascular, Medical & Research Center
Tehran, Iran, Islamic Republic of
Sponsors and Collaborators
Shahid Beheshti University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Javad Nasrollahzadeh, Director, Shahid Beheshti University of Medical Sciences
ClinicalTrials.gov Identifier: NCT04084847    
Other Study ID Numbers: 895
First Posted: September 10, 2019    Key Record Dates
Last Update Posted: October 26, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Javad Nasrollahzadeh, Shahid Beheshti University of Medical Sciences:
Barberry
Berberis vulgaris
Blood pressure
Lipids
Inflammation