This study was designed to compare the effects of olive and grape seed oil on serum lipids and blood pressure in hyperlipidemic patients referring to Obesity Center of Shahid Sadoughi University of medical sciences Specialty and Subspecialty Baghaeipour Clinic in 2014. In this parallel clinical trial, 60 hyperlipidemic patients aged 30-60 year without cardiac, renal or hepatic disease will be recruited. After obtaining informed consent, subjects will be assigned to 3 groups using the table of random numbers: 1) Consuming 20 ml/day refined olive oil (2 teaspoonful in the morning and 2 in the afternoon) 2) Consuming 20 ml/day refined grape seed oil 3) The control group will receive no oil. The intervention period is six weeks. All participants should take cardiac Step I diet. At baseline refined oil (that are colorless and odorless) will be poured in coded graded containers by a person who is not participate in the process of the study. Blood pressure is measured at baseline and after 6 weeks using a standard mercurial column sphygmomanometer (Model FC-110Deluxe, Focal Corporation, Japan). Total cholesterol, high density lipoprotein, triglyceride and fasting serum glucose will also be measured at baseline and after 6 weeks by enzymatic methods using certified commercial kits (Pars Azmon, Iran). Low density lipoprotein level will be calculated by the Friedewalds formula.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014070218329N1
Registration date:2015-02-13, 1393/11/24
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-02-13, 1393/11/24
Registrant information
Name
Fatemeh Kaseb
Name of organization / entity
Diabetes Research Center, Shahid Sadoughi University of medical sciences, Yazd, Iran
Country
Iran (Islamic Republic of)
Phone
+98 35 3821 5197
Email address
fkaseb@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Diabetes Research Center, Shahid Sadoughi University of medical sciences, Yazd, Iran
Expected recruitment start date
2014-03-22, 1393/01/02
Expected recruitment end date
2014-07-27, 1393/05/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of olive and grape seed oil consumption on metabolic responses and lipid profiles in hyperlipidemic patients
Public title
Effect of olive and grape seed oil on lipid profile
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: At least one of lipid profile indicators should be elevated (TC≥200, HDL≤40, LDL≥130، TG≥150), 30-60 years of age, lack of cardiac, renal or hepatic disease and not using antioxidant supplements, no pregnancy or lactation.
Exclusion criteria: Change in physical activity, diet or medications; using less than 80% of the given oil.
Age
From 30 years old to 60 years old
Gender
Both
Phase
N/A
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
Not used
Assignment
Parallel
Other design features
Because of using refined oil participants and researchers who conduct the study will not know which oil will be taken by them.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahid Sadoughi University of medical sciences, Yazd, Iran
Street address
Talare Honar Alley, Shahid Sadoughi Blvd.
City
Yazd
Postal code
Approval date
2013-08-17, 1392/05/26
Ethics committee reference number
پ/17/1/102034
Health conditions studied
1
Description of health condition studied
Hyperlipidemia
ICD-10 code
E78.5
ICD-10 code description
Hyperlipidaemia, unspecified
Primary outcomes
1
Description
Blood pressure
Timepoint
At the start of intervention and 6 weeks after intervention
Method of measurement
Mercurial column sphygmomanometer
2
Description
Total cholesterol
Timepoint
At the start of intervention and 6 weeks after intervention
Method of measurement
Enzymatic
3
Description
High density lipoprotein (HDL)
Timepoint
At the start of intervention and 6 weeks after intervention
Method of measurement
Enzymatic
4
Description
Triglyceride
Timepoint
At the start of intervention and 6 weeks after intervention
Method of measurement
Enzymatic
5
Description
Low density lipoprotein (LDL)
Timepoint
At the start of intervention and 6 weeks after intervention
Method of measurement
Friedewalds formula
6
Description
Very low density lipoprotein (VLDL)
Timepoint
At the start of intervention and 6 weeks after intervention
Method of measurement
Enzymatic
7
Description
weight
Timepoint
At the start of intervention and 6 weeks after intervention
Method of measurement
Seca scale
8
Description
Serum glucose
Timepoint
At the start of intervention and 6 weeks after intervention
Method of measurement
Enzymatic
9
Description
Height
Timepoint
At the start of intervention and 6 weeks after intervention
Method of measurement
Seca scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention 1: 20 mL refined grape seed oil/day (XXX company, Italy) + Having Step I diet (for 6 weeks)
Category
Lifestyle
2
Description
Intervention 2: 20 mL refined olive oil/day (Kokab Olive Oil Company, Qazvin, Iran) + Having Step I diet (for 6 weeks)
Category
Lifestyle
3
Description
Intervention 3: control: Receiving no oil and consuming + Having step I diet (for 6 weeks)
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Obesity Center, Specialty and Subspecialty Baghaeipour Clinic, Shahid Sadoughi University of medical
Full name of responsible person
Mohammad Hossein Baradaranfar
Street address
Talare Honar Alley, Shahid Sadoughi Blvd.
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Shahid Sadoughi University of medical sciences, Yazd, Iran
Full name of responsible person
Nasim Namiranian
Street address
Talare Honar Alley, Shahid Sadoughi Blvd.
City
Yazd
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 Shahid Sadoughi University of medical sciences, Yazd, Iran
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
Shahid Sadoughi University of medical sciences, Yazd, Iran
Full name of responsible person
Akram Naghdipour Biregani
Position
MSc in Health Sciences in Nutrition
Other areas of specialty/work
Street address
Shahid Sadoughi University of medical sciences, Yazd, Iran
City
Yazd
Postal code
Phone
+31 52634919
Fax
Email
naghdipour86@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Diabetes Research Center, Shahid Sadoughi University of medical sciences, Yazd, Iran
Full name of responsible person
Fatemeh Kaseb
Position
PhD in nutrition sciences
Other areas of specialty/work
Street address
Talare Honar Alley, Shahid Sadoughi Blvd.
City
Yazd
Postal code
8917693571
Phone
+353 7280228
Fax
+353 7280216
Email
fkaseb@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Sadoughi University of Medical Sciences, Yazd, Iran
Full name of responsible person
Akram Naghdipour Biregani
Position
MSc in Health sciences in nutrition
Other areas of specialty/work
Street address
department of health,Imam Reza Institute, Daneshjoo Blvd., Imam Hossein sq.
City
Yazd
Postal code
8917693571
Phone
+351 7280228
Fax
+351 7280216
Email
naghdipour86@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)