Determining the effect of olive (Olea europaea) leaf extract on glucose metabolism and liver function and biomarkers of inflammation in patients with hypertension.
Design
Random assignment was done by the use of computer-generated random numbers. Population and sample size: In the study 60 patients with high blood pressure among males and females of eligible and referred to health and clinical centers affiliated to Qazvin University of Medical Sciences, Qazvin, Iran, were selected.
Settings and conduct
In the study 60 patients with high blood pressure among males and females of eligible and referred to health and clinical centers affiliated to Qazvin University of Medical Sciences, Qazvin, Iran, were selected.
Participants/Inclusion and 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 did not want to cooperate; hypertensive patients who had others complications such as: kidney disease؛ neuropathy and retinopathy, patients with hypo and/or hyperthyroidism wrere excluded from this study.
Intervention groups
Patients were assigned to receive either extract (intervention group: n=30) or placebo (control group: n=30).
Main outcome variables
Glucose metabolism, liver function and biomarkers of inflammation in patients with high blood pressure werevmeasured before and after of the intervention.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170430033730N5
Registration date:2018-09-25, 1397/07/03
Registration timing:retrospective
Last update:2018-09-25, 1397/07/03
Update count:0
Registration date
2018-09-25, 1397/07/03
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
Expected recruitment start date
2017-10-23, 1396/08/01
Expected recruitment end date
2018-02-20, 1396/12/01
Actual recruitment start date
2017-12-05, 1396/09/14
Actual recruitment end date
2018-03-07, 1396/12/16
Trial completion date
2018-08-20, 1397/05/29
Scientific title
Olive (Olea europaea) leaf extract effect on glucose metabolism and liver function and biomarkers of inflammation in patients with high blood presurer
Public title
Olive (Olea europaea) leaf extract effect on glucose and inflammation
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 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization, Random assignment was done by the use of computer-generated random numbers.
Blinding (investigator's opinion)
Double blinded
Blinding description
A placebo was used to blind. Researchers and Patients will be blinded by the professional analyst until final analysis.
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
Province
Qazvin
Postal code
3419759811
Approval date
2017-09-02, 1396/06/11
Ethics committee reference number
IR.QUMS.REC.1396.240
Health conditions studied
1
Description of health condition studied
Essential hypertension
ICD-10 code
I10
ICD-10 code description
Essential (primary) hypertension
Primary outcomes
1
Description
FBS
Timepoint
At the beginning of the study and 12 weeks after the intervention
Method of measurement
Spectrophotometry
2
Description
Insulin
Timepoint
At the beginning of the study and 12 weeks after the intervention
Method of measurement
ELISA
Secondary outcomes
1
Description
AST
Timepoint
At the beginning of the study and 12 weeks after the intervention
Method of measurement
Spectrophotometry
2
Description
ALT
Timepoint
At the beginning of the study and 12 weeks after the intervention
Method of measurement
Spectrophotometry
3
Description
ALKP
Timepoint
At the beginning of the study and 12 weeks after the intervention
Method of measurement
Spectrophotometry
4
Description
TP
Timepoint
At the beginning of the study and 12 weeks after the intervention
Method of measurement
Spectrophotometry
5
Description
Alb
Timepoint
At the beginning of the study and 12 weeks after the intervention
Method of measurement
Spectrophotometry
6
Description
TNF-α
Timepoint
At the beginning of the study and 12 weeks after the intervention
Method of measurement
ELISA
7
Description
IL-6
Timepoint
At the beginning of the study and 12 weeks after the intervention
Method of measurement
ELISA
8
Description
IL-8
Timepoint
At the beginning of the study and 12 weeks after the intervention
Method of measurement
ELISA
9
Description
hs-CRP
Timepoint
At the beginning of the study and 12 weeks after the intervention
Method of measurement
ELISA
10
Description
Omentin
Timepoint
At the beginning of the study and 12 weeks after the intervention
Method of measurement
ELISA
11
Description
BUN
Timepoint
At the beginning of the study and 12 weeks after the intervention
Method of measurement
Spectrophotometry
12
Description
Creatinin
Timepoint
At the beginning of the study and 12 weeks after the intervention
Method of measurement
Spectrophotometry
13
Description
Uric Acid
Timepoint
At the beginning of the study and 12 weeks after the intervention
Method of measurement
Spectrophotometry
Intervention groups
1
Description
Intervention group: Two capsules of 275 mg of extract were taken twice daily for twelve weeks
Category
Treatment - Drugs
2
Description
Control group: Two capsules of 250 mg of placebo were taken twice a day for 12 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Boo-Ali Hospital
Full name of responsible person
Dr Seyyed Mehdi Mirhashemi
Street address
Shahid Bahonar Blovard
City
Qazvin
Province
Qazvin
Postal code
34197 - 59811
Phone
+98 28 3333 6001
Email
mirhashemism@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Amir Peimani
Street address
Vice Chancellor for research of Qazvin University of Medical Sciences- Shahid Beheshti Blvd-Qazvin
City
Qazvin
Province
Qazvin
Postal code
34156-13911
Phone
+98 28 3333 7006
Email
a.peymani@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Seyyed Mehdi Mirhashemi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Biochemistry
Street address
Shahid Bahonar Blovard
City
Qazvin
Province
Qazvin
Postal code
34197-59811
Phone
+98 28 3333 6001
Email
mirhashemism@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Seyyed Mehdi Mirhashemi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Biochemistry
Street address
Shahid Bahonar Blovard
City
Qazvin
Province
Qazvin
Postal code
34197-59811
Phone
+98 28 3333 6001
Email
mirhashemism@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Seyyed Mehdi Mirhashemi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Biochemistry
Street address
Shahid Bahonar Blovard
City
Qazvin
Province
Qazvin
Postal code
34197-59811
Phone
+98 28 3333 6001
Email
mirhashemism@gmail.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
There is no further information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available