short-and long term effects of pomegranate juice consumption in inflammatory factors( hs-CRP; ICAM; VCAM; IL-6; E-Selectin ) and blood pressure and endothelial function evaluation (FMD) in hypertensive patients
In this Clinical Trial in hypertensive patients, 30 hypertensive patients will be selected. The purpose of this study is to investigate the effect of pomegranate juice consumption on pro-inflammatory cytokines, lipid profile levels, flow-mediated dilatation (FMD) and Blood pressure (BP) in hypertensive patients. Individuals with a history of diabetes; cardiovascular disease; liver and kidney disease as well as those with thyroid disease; pregnant and breastfeeding, metabolic and endocrine diseases and smoking will be exclude. FMD measurement will done using high-frequency ultrasonography of the brachial artery, blood pressure gauge using a sphygmomanometer and the inflammatory markers (hs-CRP-ICAM-VCAM-IL-6-E-Selecti) and lipid profile levels will be measured using ELISA kits. 30 Participants are randomly divided into two groups. One groups control and another Case (Experiment) groups. And case groups will be consume 150mL pomegranate juice and control groups will be consume 150mL water ; once a day between launch to dinner for 2 weeks, at the beginning and end of a 2-week period, above mentioned factors will be measured.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201206249662N4
Registration date:2012-08-09, 1391/05/19
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-08-09, 1391/05/19
Registrant information
Name
Sedigheh Asgary
Name of organization / entity
Isfahan Cardiovascular Research Center ,Isfahan Cardiovascular Research institute , Physiology Re
Country
Iran (Islamic Republic of)
Phone
+98 31 1335 9090
Email address
s_asgari@crc.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan Cardiovascular Research Center
Expected recruitment start date
2012-07-22, 1391/05/01
Expected recruitment end date
2012-08-04, 1391/05/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
short-and long term effects of pomegranate juice consumption in inflammatory factors( hs-CRP; ICAM; VCAM; IL-6; E-Selectin ) and blood pressure and endothelial function evaluation (FMD) in hypertensive patients
Public title
effects of pomegranate juice consumption in inflammatory factors( hs-CRP; ICAM; VCAM; IL-6; E-Selectin ) and blood pressure and endothelial function evaluation (FMD) in hypertensive patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: hypertensive patients whit :BMI more than 18 and less than 35kg/m2 ; Systolic blood pressure (SBP) more than 100 and less than 160 mm Hg; Diastolic blood pressure (DBP) more than 50 and less than 100 mm Hg
Exclusion criteria: Individuals with a history of diseases; diabetes; cardiovascular disease; liver and kidney as well as those with thyroid disease; pregnant and breastfeeding; metabolic and endocrine diseases
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
22
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan Cardiovascular Research Center, Isfahan Cardiovascular Research in
Street address
Khorram Street, Jomhori Square
City
Isfahan
Postal code
0098
Approval date
2007-10-08, 1386/07/16
Ethics committee reference number
86110
Health conditions studied
1
Description of health condition studied
Blood pressure
ICD-10 code
I10-I15
ICD-10 code description
Hypertensive diseases
2
Description of health condition studied
flow-mediated dilatation (FMD)
ICD-10 code
I70-I79
ICD-10 code description
Diseases of arteries, arterioles and capillaries
Primary outcomes
1
Description
Positive changes in inflammatory markers
Timepoint
Baseline and after 2 weeks
Method of measurement
ELISA kit
2
Description
Positive changes in endothelial function
Timepoint
Baseline and after 2weeks
Method of measurement
Doppler ultrasonography
Secondary outcomes
1
Description
blood pressure
Timepoint
Baseline and after 2 weeks
Method of measurement
Sphygmomanometer
2
Description
Positive changes in lipid profiles
Timepoint
Baseline and after 2 weeks
Method of measurement
kit
3
Description
Cholesterol Level
Timepoint
Before and after 2 weeks
Method of measurement
KIT
4
Description
HDL Level
Timepoint
Before and after 4 weeks
Method of measurement
KIT
5
Description
LDL level
Timepoint
Before and after 2weeks
Method of measurement
KIT
Intervention groups
1
Description
In group 1(case)15 hypertensive patients, 150 ml consumption of fresh Pomegranate juice. once a day between launch to dinner for 2 weeks.
Category
N/A
2
Description
In group 2(Control)15 hypertensive patients, 150 ml consumption of Water for 2 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Sedigheh tahere Cardiovascular Research Center
Full name of responsible person
Mahtab keshvari
Street address
Khorram Street, Jomhori Square
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan Cardiovascular Research Center
Full name of responsible person
dr.bahonar
Street address
Khorram Street, Jomhoori Square
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan Cardiovascular Research Center
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan Cardiovascular Research Center, Physiology Research Center, Isfahan University of Medical S
Full name of responsible person
Sedigheh Asgary
Position
Pharmacist and PhD Pharmacogenetics
Other areas of specialty/work
Street address
Khorram Street, Jomhoori Square
City
Isfahan
Postal code
Phone
+98 31 1355 9595
Fax
Email
sasgary@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan Cardiovascular Research Center
Full name of responsible person
Mahtab keshvari
Position
MSc / BSc Research
Other areas of specialty/work
Street address
Cardiovascular Research Center, Khorram Street, Jomhoori Square
City
Isfahan
Postal code
Phone
+98 31 1335 9595
Fax
Email
mahtabkeshvari87@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)