- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04084847
Berberis Vulgaris Consumption and Blood Pressure
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
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Tehran, Iran, Islamic Republic of
- Rajaei Cardiovascular, Medical & Research Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Sponsor
Publications and helpful links
General Publications
- Emamat H, Zahedmehr A, Asadian S, Nasrollahzadeh J. The effect of barberry (Berberis integerrima) on lipid profile and systemic inflammation in subjects with cardiovascular risk factors: a randomized controlled trial. BMC Complement Med Ther. 2022 Mar 7;22(1):59. doi: 10.1186/s12906-022-03539-8.
- Emamat H, Zahedmehr A, Asadian S, Tangestani H, Nasrollahzadeh J. Effect of barberry (Berberis vulgaris) consumption on blood pressure, plasma lipids, and inflammation in patients with hypertension and other cardiovascular risk factors: study protocol for a randomized clinical trial. Trials. 2020 Nov 27;21(1):986. doi: 10.1186/s13063-020-04918-7.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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