Comparison of the effect of powdered Berberis vulgaris and placebo consumption on flow mediated dilation and vascular inflammatory biomarkers in hypertensive subjects
The effect of powdered Berberis vulgaris consumption on flow mediated dilation and vascular inflammatory biomarkers in hypertensive subjects
Design
A single center, randomized, not blinded, controlled clinical trial with a parallel group design and 78 participants
Settings and conduct
Seventy six patients with previous history of hypertension and at least one cardiovascular risk factor, referred to Rajaee hospital, will be randomized into two groups, barberry powder (10 g per day) or placebo (10 g) for 8 weeks. Flow mediated dilation and plasma levels of ICAM and VCAM are measured at baseline and after 8 weeks . Patients did not know the type of intervention and the study was single blind.
Participants/Inclusion and exclusion 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.
Intervention groups
Intervention group: receiving 10 g of barberry powder for 8 weeks.
Control group: receiving 10 g placebo powder containing maltodextrin, citric acid and oral red for 8 weeks.
Main outcome variables
Flow mediated dilation (FMD);
ICAM and VCAM inflammatory factors
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160702028742N8
Registration date:2020-03-20, 1399/01/01
Registration timing:registered_while_recruiting
Last update:2020-03-20, 1399/01/01
Update count:0
Registration date
2020-03-20, 1399/01/01
Registrant information
Name
Javad Nasrollahzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2236 0656
Email address
jnasrolah@razi.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-21, 1398/11/01
Expected recruitment end date
2020-05-21, 1399/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of powdered Berberis vulgaris and placebo consumption on flow mediated dilation and vascular inflammatory biomarkers in hypertensive subjects
Public title
Effect of powdered Berberis vulgaris on vascular function
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to participate in the study
Age between 20-65 years
Having elevated blood pressure (129/ < 85) or known hypertensive patients on medical treatment
At least one other classical cardiovascular disease risk factors, including hyperlipidemia or diabetes mellitus
Exclusion criteria:
BMI> 30
Patients on nitrate drugs
High doses of statins consumption (Atorvastatin>40 mg/day or Rosuvastatin>20 mg/day)
Regular consumption (more than once in a week) of vitamins or minerals supplements during past month
Chronic kidney disease stage 4 or 5
Age
From 20 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
76
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, 76 subjects with previous history of hypertension and on hypertension medication will be randomized into two groups: barberry or placebo for 2 months. Stratified block randomization will be employed to assign subject to each of the two groups. Stratification subdivides patients into those with diabetes or without diabetes and in each stratum, blocks of size 4 (two intervention and two placebo) will be defined and then the patients within each block will be assigned to intervention and control groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients are blinded of the type of powder they are consuming, but the main investigator who assigns patients to intervention or placebo groups is not blinded. Powders are given to patients in undetectable non-transparent packaging.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahid Beheshti University of Medical Sciences
Street address
No. 46, West Arghavan Ave., Farahzadi Blvd., Qods Town
City
Tehran
Province
Tehran
Postal code
1981619573
Approval date
2019-09-02, 1398/06/11
Ethics committee reference number
IR.SBMU.NNFTRI.REC.1398.046
Health conditions studied
1
Description of health condition studied
hypertension
ICD-10 code
I10
ICD-10 code description
Essential (primary) hypertension
Primary outcomes
1
Description
Flow mediated dilation (FMD)
Timepoint
Baseline and the end of the study
Method of measurement
sonography
Secondary outcomes
1
Description
plasma ICAM-1
Timepoint
Baseline and the end of the study
Method of measurement
ELISA
2
Description
Plasma VCAM-1
Timepoint
Baseline and the end of the study
Method of measurement
ELISA
Intervention groups
1
Description
Intervention group: Daily consumption of 10 gram of barberry powder for 8 weeks. Barberry is purchased from the local market at one time.
Category
Treatment - Other
2
Description
Control group: Daily consumption of 10 gram of placebo powder (Contains maltodextrin, citric acid and edible red color) for 8 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Rajaee Cardiovascular, Medical & Research Center
Full name of responsible person
Dr Ali Zahedmehr
Street address
Niyayesh intersection, Valiasr Street, Tehran
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 23921
Email
arashzahedmehr@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Morteza Abdollahi
Street address
No. 46, Hafezi street, Farahzadi blvd, Qods Town, Tehran
City
Tehran
Province
Tehran
Postal code
1981619573
Phone
+98 21 2236 0658
Email
jnasrollahzadeh@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Hadi Emamat
Position
Ph.D. Student in Nutrition Sciences
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
No. 46, Hafezi street, Farahzadi blvd, Qods Town, Tehran
City
Tehran
Province
Tehran
Postal code
1981619573
Phone
+98 31 5545 0314
Email
hadiemamat@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Javad Nasrollahzadeh
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
No. 46, Hafezi street, Farahzadi blvd, Qods Town, Tehran
City
Tehran
Province
Tehran
Postal code
1981619573
Phone
+98 21 2207 7424
Email
jnasrollahzadeh@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Hadi Emamat
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
No. 46, Hafezi street, Farahzadi blvd, Qods Town, Tehran
City
Tehran
Province
Tehran
Postal code
1981619573
Phone
+98 31 5545 0314
Email
hadiemamat@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD