Berberis Vulgaris Consumption and Blood Pressure

NCT ID: NCT04084847

Last Updated: 2020-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-18

Study Completion Date

2020-10-21

Brief Summary

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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

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Conditions

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Blood Pressure Cardiovascular Risk Factor Lipid Profile

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Barberry

Daily consumption of barberry in powder form.

Group Type ACTIVE_COMPARATOR

berberis vulgaris=barberry

Intervention Type DIETARY_SUPPLEMENT

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

placebo

Daily consumption of placebo powder.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo powder

Interventions

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berberis vulgaris=barberry

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

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo powder

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shahid Beheshti University

OTHER

Sponsor Role lead

Responsible Party

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Javad Nasrollahzadeh

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Rajaei Cardiovascular, Medical & Research Center

Tehran, , Iran

Site Status

Countries

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Iran

References

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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.

Reference Type DERIVED
PMID: 35255880 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33246500 (View on PubMed)

Other Identifiers

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895

Identifier Type: -

Identifier Source: org_study_id