This study was done to compare the effects of liquid, semi-hydrogenated (free trans fatty acid) and ghee oils with hydrogenated, oil on serum lipids profile of healthy adults. This study was a randomized clinical trial conducted on 200 healthy participants aged 20-60 years old who were beneficiaries of Imam-e-Zaman charity Association. The participants were randomly assigned into 5 groups and each group was treated with a diet containing cooking and frying liquid, ghee, semi-hydrogenated oil (free trans fatty acid), soft margarine or hydrogenated for 40 days. Fasting serum lipids, including total cholesterol (TC), triglyceride (TG), LDL-C, HDL-C, apoprotein A (Apo A), and apoprotein B (Apo B) were measured before and after the study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138905124497N1
Registration date:2010-11-26, 1389/09/05
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-11-26, 1389/09/05
Registrant information
Name
Noushin Mohammadifard
Name of organization / entity
Isfahan Cardiovascular Research Center, Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1337 7883
Email address
mohammadifard@crc.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan Cardiovascular Research Center, Isfahan University of Medical Sciences
Expected recruitment start date
2006-09-23, 1385/07/01
Expected recruitment end date
2009-06-20, 1388/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of different oil consumption on serum lipids in adults of Isfahan City
Public title
Effect of different oil on serum lipids
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Normal HTN, no diabetes, no cardiovascular diseases
Exclusion criteria: TC≥240mg/dl, TG≥400mg/dl, LDL-C≥160mg/dl, HDL-C≥40mg/dl, body mass index (BMI) ≥35
Age
From 20 years old to 60 years old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
200
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
Research Council of Cardiovascular Research Center, ISfahan University of Medical Sciences
Street address
Cardiovascular Research Center, Sedigheh Tahereh Research Center, Khoram St.
City
Isfahan
Postal code
1148-81465
Approval date
empty
Ethics committee reference number
84112
Health conditions studied
1
Description of health condition studied
Hyperlipidemia
ICD-10 code
E78.5
ICD-10 code description
Hyperlipidemia
Primary outcomes
1
Description
Total Cholesterol
Timepoint
Before and 40 days after the interventiondays
Method of measurement
Measurement (Autoanalyzer)
2
Description
Triglyceride
Timepoint
Before and 40 days after the interventiondays
Method of measurement
Measurement (Autoanalyzer)
3
Description
LDL
Timepoint
Before and 40 days after the interventiondays
Method of measurement
Calculating by Friedewald Formula
4
Description
HDL
Timepoint
Before and 40 days after the interventiondays
Method of measurement
Measurement (Autoanalyzer)
5
Description
Apoprotein A
Timepoint
Before and 40 days after the interventiondays
Method of measurement
Measurement (Autoanalyzer)
6
Description
Apoprotein B
Timepoint
Before and 40 days after the intervention
Method of measurement
Measurement (Autoanalyzer)
Secondary outcomes
empty
Intervention groups
1
Description
Unhydrogenated oil and Frying oil, Dosage: Calculating based on individual dietary pattern Period: 40 days Usage method: In diet
Category
Prevention
2
Description
Semihydrogenated oil (Free trans fatty acid), Dosage: Calculating based on individual dietary pattern Period: 40 days Usage method: In diet
Category
Prevention
3
Description
Ghee oil, Dosage: Calculating based on individual dietary pattern Period: 40 days Usage method: In diet
Category
Prevention
4
Description
Soft Margarine, Dosage: Calculating based on individual dietary pattern Period: 40 days Usage method: In diet
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam-e-Zaman Charity Association
Full name of responsible person
Street address
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan Cardiovascular Research Center, Isfahan University of Medical Sciences
Full name of responsible person
Ahmad Bahonar
Street address
Isfahan Cardiovascular Research Center, Sedigheh Tahereh Research Center, Khoram St.
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, Isfahan 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
Isfahan Cardiovascular Research Center, Isfahan University of Medical Sciences