Effect of Sesame Oil (Sesamum Indicum Linn.) consumption on lipid profile of patients with dyslipidemia referred to Health Heart House affiliated to Shiraz Cardiovascular Research Center.
This study has been designed to assess the effect of Seasame Oil on lipid profile in patients suffering from dyslipidemia, referred to The Health Heart House, affiliated to Shiraz Cardiovascular Research Center. In this randomized controlled clinical study, 135 people suffering from dyslipidemia aged between 18-75 referred to Shiraz Heart House have been selected according to the inclusion criteria, including Low-density lipoprotein (LDL) between 130-200 or High-density lipoprotein (HDL) in females under 50 and males under 40 or Triglyceride between 200-400 and the use of no antilipidemic drugs. The exclusion criteria have been pregnancy, breastfeeding, and the use of oral contraceptive pills(OCP) and antilipidemic drugs. These persons have randomly been divided into experiment group (90 persons), receiving Seasame Oil and control group (45 persons). The experiment group has been given 15 grams of Seasame Oil daily for 2 months and the control group hasn’t received any intervention during this period. At the end, total cholesterol, Low-density lipoprotein (LDL), High-density lipoprotein (HDL) and Triglyceride before and after intervention have been checked and compared with each other.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013060913603N1
Registration date:2013-08-13, 1392/05/22
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-08-13, 1392/05/22
Registrant information
Name
Majid Barzegar
Name of organization / entity
Shiraz University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
00987112352559,00987112332366
Email address
barzegaram@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2013-08-06, 1392/05/15
Expected recruitment end date
2013-11-06, 1392/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Sesame Oil (Sesamum Indicum Linn.) consumption on lipid profile of patients with dyslipidemia referred to Health Heart House affiliated to Shiraz Cardiovascular Research Center.
Public title
Effect of Sesame Oil (Sesamum Indicum Linn.) consumption on lipid profile in patients with dyslipidemia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age 18-75 year old; Low-density lipoprotein (LDL) 130-200 or triglyceride 200-400 or High-density lipoprotein (HDL) less 50 in female and less 40 in male; non-use antilipideimic drugs; non history of renal, liver, kidney, heart and thyroid disease; non history of diabetes mellitus; non history of food allergy especially to soya, peanuts and Walnuts; non history of asthma or atopic dermatitis.
Exclusion criteria: breastfeeding and pregnancy; oral contraceptive pills consumption; use of antilipideimic drugs; alcohol consumption; hospitalization during study.
Age
From 18 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
135
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Sciences, Zand St, Shiraz
City
Shiraz
Postal code
۷۱۳۴۸۱۴۳۳۶
Approval date
2013-05-14, 1392/02/24
Ethics committee reference number
CT-P-92-5339
Health conditions studied
1
Description of health condition studied
Hyperlipidemia
ICD-10 code
E78
ICD-10 code description
Disorders of lipoprotein metabolism and other lipidaemias
Primary outcomes
1
Description
total cholesterol
Timepoint
before and 2 months after intervention
Method of measurement
biochemical measurements on blood sample
2
Description
Serum Triglyceride
Timepoint
before and 2 months after intervention
Method of measurement
biochemical measurements on blood sample
3
Description
Low-density lipoprotein (LDL)
Timepoint
before and 2 months after intervention
Method of measurement
biochemical measurements on blood sample
4
Description
High-density lipoprotein (HDL)
Timepoint
before and 2months after intervention
Method of measurement
biochemical measurements on blood sample
Secondary outcomes
1
Description
Diastolic Blood Pressure
Timepoint
before and 2 months after intervention
Method of measurement
before and 2 months after intervention
2
Description
Systolic Blood Pressure
Timepoint
before and 2 months after intervention
Method of measurement
before and 2 months after intervention
3
Description
Body Mass Index
Timepoint
before and 2 months after intervention
Method of measurement
before and 2 months after intervention
4
Description
Weight
Timepoint
before and 2 months after intervention
Method of measurement
before and 2 months after intervention
Intervention groups
1
Description
Control group : no intervention
Category
Other
2
Description
Intervention group:use seasame oil orally 15 grams per day for 60 days
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Cardiovascular Research Center of Shiraz University of Medical Sciences
Full name of responsible person
Majid Barzegar
Street address
Cardiovascular Research Center, Shahid Faghihi Hospital, Zand Blvd, Shiraz
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Midical Sciences
Full name of responsible person
Mrs Hoghooghi
Street address
Cardiovascular Research center,Shahid Faghihi Hospital,Zand Blvd, Shiraz
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Midical 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
Shiraz University of Medical Sciences
Full name of responsible person
Majid Barzegar
Position
Resident of Cardiology
Other areas of specialty/work
Street address
Shiraz University of Medical Sciences, Zand St, Shiraz
City
Shiraz
Postal code
۷۱۳۴۸۱۴۳۳۶
Phone
+98 71 1233 2366
Fax
+98 71 1235 9317
Email
barzegaram@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Cardiovascular Research Center of Shiraz
Full name of responsible person
Dr. Mohammad Javad Zibaeenejhad
Position
Fellowship of Interventional Cardiology
Other areas of specialty/work
Street address
Cardiovascular Research Center, Shahid Faghihi Hospital, Shiraz
City
Shiraz
Postal code
7134844119
Phone
+98 71 1234 3529
Fax
+98 23 43529
Email
zibaeem2@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Majid Barzegar
Position
Resident of Cardiology
Other areas of specialty/work
Street address
Shiraz University of Medical Sciences, Zand St, Shiraz
City
Shiraz
Postal code
۷۱۳۴۸۱۴۳۳۶
Phone
+98 71 1233 2366
Fax
+98 23 59317
Email
barzegaram@sums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)