Berberis Vulgaris Consumption and Blood Pressure

NCT04084847 | Completed

• 1 other identifier: 895
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Blood Pressure; Cardiovascular Risk Factor; Lipid Profile

Keywords

Barberry; Berberis vulgaris; Blood pressure; Lipids; Inflammation

Outcome Measures

Primary Outcomes (1)

• blood pressure

  mean of systolic and diastolic blood pressure of participants measured by ambulatory 24 hour blood pressure monitoring

  at 8 weeks

Secondary Outcomes (3)

• lipid profile

  at 8 weeks

• plasma NOx

  at 8 weeks

• Inflammatory cytokine

  at 8 weeks

Study Arms (2)

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

berberis vulgaris=barberry DIETARY_SUPPLEMENT

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

Barberry

Placebo DIETARY_SUPPLEMENT

Placebo powder

placebo

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shahid Beheshti University: lead

Study Sites (1)

Rajaei Cardiovascular, Medical & Research Center

Tehran, Iran

Location

Related Publications (2)

• 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.

  PMID: 35255880 DERIVED

• 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.

  PMID: 33246500 DERIVED

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: September 3, 2019
• First Posted: September 10, 2019
• Study Start: September 18, 2019
• Primary Completion: August 19, 2020
• Study Completion: October 21, 2020
• Last Updated: October 26, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)