Blood PressureNCT04084847
Berberis Vulgaris Consumption and Blood Pressure
A study testing berberis vulgaris=barberry in people with Blood Pressure and Cardiovascular Risk Factor, run by Shahid Beheshti University at 1 site in Iran.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Blood Pressure, Cardiovascular Risk Factor, Lipid Profile
- What is being tested?
- berberis vulgaris=barberry
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 1 siteIran
- Study dates
- 18 Sep 2019to 21 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Blood Pressure, Cardiovascular Risk Factor, Lipid Profile
- Being tested
- berberis vulgaris=barberry, Placebo
- Keywords
- Barberry, Berberis vulgaris, Blood pressure, Lipids, Inflammation
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
berberis vulgaris=barberryDietary supplement
10 grams of barberry powder will be consumed daily for 8 weeks.
PlaceboDietary supplement
Placebo powder
| Study group | Role | What they receive |
|---|---|---|
| Barberry | Active comparator | Daily consumption of barberry in powder form. Receives: Dietary Supplement: berberis vulgaris=barberry |
| placebo | Placebo comparator | Daily consumption of placebo powder. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood pressure
mean of systolic and diastolic blood pressure of participants measured by ambulatory 24 hour blood pressure monitoring
Measured: at 8 weeks
Secondary outcomes (3)
lipid profile
plasma TC, LDL-C, HDL-C, TG
Measured: at 8 weeks
plasma NOx
concentration of nitrite and nitrate in plasma
Measured: at 8 weeks
Inflammatory cytokine
Plasma Interleukin-6
Measured: at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2019
- Study start18 Sep 2019
- Primary completion19 Aug 2020
- Study completion21 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Javad Nasrollahzadeh, Shahid Beheshti University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04084847
- Sponsor's protocol ID
- 895
- Status last verified
- Oct 2020
- First submitted
- 3 Sep 2019
- Last updated
- 26 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 35255880Emamat 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.
PubMed 33246500
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Berberis Vulgaris Consumption on Blood Pressure and Plasma Lipids in Subjects With Cardiovascular Risk Factors
- ClinicalTrials.gov ID
- NCT04084847
- Acronym / sponsor ID
- 895
- Conditions
- Blood Pressure, Cardiovascular Risk Factor, Lipid Profile
- Keywords
- Barberry, Berberis vulgaris, Blood pressure, Lipids, Inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Shahid Beheshti UniversityUniversity, hospital or other
- Study start
- 18 Sep 2019 (actual)
- Primary completion
- 19 Aug 2020 (actual)
- Study completion
- 21 Oct 2020 (actual)
- First posted
- 10 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Barberry | Active comparator | Dietary Supplement: berberis vulgaris=barberryDaily consumption of barberry in powder form. |
| placebo | Placebo comparator | Dietary Supplement: PlaceboDaily consumption of placebo powder. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| berberis vulgaris=barberry10 grams of barberry powder will be consumed daily for 8 weeks. | Dietary supplement | Barberry |
| PlaceboPlacebo powder | Dietary supplement | placebo |
Primary outcome
blood pressure
Time frame: at 8 weeks
mean of systolic and diastolic blood pressure of participants measured by ambulatory 24 hour blood pressure monitoring
3 secondary outcomes
lipid profile
Time frame: at 8 weeks
plasma NOx
Time frame: at 8 weeks
Inflammatory cytokine
Time frame: at 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2020.
- Derived from this study: PubMed 35255880Emamat 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.
- Derived from this study: PubMed 33246500Emamat 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing berberis vulgaris=barberry in people with Blood Pressure and Cardiovascular Risk Factor, run by Shahid Beheshti University at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
blood pressure (time frame: at 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04084847, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2020.