Objectives: determining the effect of olive (Olea europaea) leaf extract on blood pressure and oxidative stress parameters and lipid profiles in patients with hypertension. Design: parallel double-blind randomized controlled clinical trial. Inclusion criteria: subjects with systolic blood pressure (SBP) above 140 mmHg or diastolic blood pressure (DBP) above 90 mmHg. Exclusion criteria: patients who do not want to cooperat; hypertensive patients who have others complications such as: kidney disease؛ neuropathy and retinopathy, patients with hypo and/or hyperthyroidism are excluded from this study. Population and sample size: 60 subjects with hypertension, eligible and referred to Boo-Ali hospital affiliated to Qazvin University of Medical Sciences, Qazvin, Iran will be selected. Intervention: patients will be assigned to receive either 500 mg olive (Olea europaea) leaf extract (intervention group: n=30) or placebo (control group: n=30). Fasting blood samples will be taken at baseline and after 12-wk intervention to evaluate status of oxidative stress and lipid profiles. Outcomes: blood pressure, status of oxidative stress such as MDA and total antioxidant capacity and lipid profile such as total cholesterol, triglyceride, HDL and LDL will be measured at baseline and end-of-trial.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017043033730N1
Registration date:2017-05-31, 1396/03/10
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-05-31, 1396/03/10
Registrant information
Name
Seyyed Mehdi Mirhashemi
Name of organization / entity
Qazvin University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 28 3333 6001
Email address
sm.mirhashemi@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Qazvin University of Medical Sciences, Qazvin University of Medical Sciences,
Expected recruitment start date
2017-05-08, 1396/02/18
Expected recruitment end date
2017-06-08, 1396/03/18
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of olive (Olea europaea) leaf extract on blood pressure and oxidative stress parameters and lipid profiles in patients with hypertension
Public title
Olive (Olea europaea) leaf extract on blood pressure
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: subjects with systolic blood pressure (SBP) above 140 mmHg or diastolic blood pressure (DBP) above 90 mmHg. Exclusion criteria: patients who do not want to cooperate; hypertensive patients who have others complications such as: kidney disease؛ neuropathy and retinopathy; patients with hypo and/or hyperthyroidism are excluded from this study.
Age
From 30 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Qazvin University of Medical Sciences
Street address
Qazvin University of Medical Sciences, Shahid Bahonar Blvd
City
Qazvin
Postal code
Approval date
2017-01-25, 1395/11/06
Ethics committee reference number
IR.QUMS.REC.1395.264
Health conditions studied
1
Description of health condition studied
Essential hypertension
ICD-10 code
I10
ICD-10 code description
Hypertensive diseases
Primary outcomes
1
Description
Blood Pressure
Timepoint
Before and after intervention
Method of measurement
based on mmHg using sphigmomanometer
2
Description
MDA
Timepoint
Before and after intervention
Method of measurement
Elisa
3
Description
Total antioxidant capacity
Timepoint
Before and after intervention
Method of measurement
spectrophotometeric
4
Description
Lipid profiles
Timepoint
Before and after intervention
Method of measurement
spectrophotometeric
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group: olive leaf extract as 250 mg tablet, orally ,twice a day for 12 weeks.
Category
Treatment - Drugs
2
Description
The control group: Cellulose as 250 mg tablet as placebo, orally twice a day for 12 weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Boo-Ali Hospital
Full name of responsible person
Dr Seyyed Mehdi Mirhashemi
Street address
City
Qazvin
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Qazvin University of Medical Sciences
Full name of responsible person
Dr Seyyed Mehdi Mirhashemi
Street address
Vice Chancellor for research of Qazvin University of Medical Sciences- Shahid Beheshti Blvd-Qazvin
City
Qazvin
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Qazvin University of Medical Sciences
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
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr. Seyyed Mehdi Mirhashemi
Position
PhD in Clinical Biochemistry
Other areas of specialty/work
Street address
Shahid Babaei Faculty of Medicine
City
Qazvin
Postal code
Phone
+98 28 3333 6001
Fax
Email
mirhashemism@gmail.com; sm.mirhashemi@qums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr. Seyyed Mehdi Mirhashemi
Position
PhD in Clinical Biochemistry
Other areas of specialty/work
Street address
Shahid Babaei Faculty of Medicine
City
Qazvin
Postal code
Phone
+98 28 3333 6001
Fax
Email
mirhashemism@gmail.com; sm.mirhashemi@qums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr. Seyyed Mehdi Mirhashemi
Position
Academic Member
Other areas of specialty/work
Street address
Shahid Bahonar Blovard, Qazvin University of Medical Sciences
City
Qazvin
Postal code
Phone
+98 28 3333 6001
Fax
Email
mirhashemism@gmail.com; sm.mirhashemi@qums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)