Berberis Vulgaris Consumption and Blood Pressure | NCT04084847

Studies
Berberis Vulgaris Consumption and Blood Pressure

NCT04084847

Sponsor

Shahid Beheshti University

Status

Completed

Last Update Posted

Oct 26, 2020Actual

Enrollment

78Actual

Phase

Not Applicable

Conditions

Blood Pressure
Cardiovascular Risk Factor
Lipid Profile

Interventions

berberis vulgaris=barberry
Placebo

Countries

Iran

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 18, 2019Actual

Primary Completion Date

Aug 19, 2020Actual

Completion Date

Oct 21, 2020Actual

First Submitted Date

Sep 3, 2019

First Submission Date that Met QC Criteria

Sep 7, 2019

First Posted Date

Sep 10, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 23, 2020

Last Update Posted Date

Oct 26, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Javad Nasrollahzadeh, Director, Shahid Beheshti University of Medical SciencesPrincipal Investigator

Lead Sponsor

Shahid Beheshti UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

78Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Barberry	Active Comparator	Daily consumption of barberry in powder form.	Dietary Supplement: berberis vulgaris=barberry
placebo	Placebo Comparator	Daily consumption of placebo powder.	Dietary Supplement: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
berberis vulgaris=barberry	Dietary Supplement	10 grams of barberry powder will be consumed daily for 8 weeks.	Barberry

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
blood pressure	mean of systolic and diastolic blood pressure of participants measured by ambulatory 24 hour blood pressure monitoring	at 8 weeks

Secondary Outcomes

Measure	Description	Time Frame
lipid profile	plasma TC, LDL-C, HDL-C, TG	at 8 weeks
plasma NOx	concentration of nitrite and nitrate in plasma	at 8 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rajaei Cardiovascular, Medical & Research Center		Tehran			Iran

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
35255880	Derived	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.
33246500	Derived

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms