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Completed

NCT Number: NCT04084847

Berberis Vulgaris Consumption and Blood Pressure

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.

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Key information

Conditions

Blood Pressure Cardiovascular Risk Factor Inflammation Lipid Profile Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rajaei Cardiovascular, Medical & Research Center

Tehran, Iran

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

berberis vulgaris=barberry

Dietary Supplement

10 grams of barberry powder will be consumed daily for 8 weeks.

Placebo

Dietary Supplement

Placebo powder

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Shahid Beheshti University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Sep 10, 2019
Registry last updated
Oct 26, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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