Evaluation the effect of conjugated linoleic acid and omega 3 fatty acids supplements on lipid profile, inflammatory factors and oxidative stress indices on patients with atherosclerosis
This randomized clinical trial will be conducted to evaluate the effect of Conjugated linoleic acid and omega3 fatty acids supplements on atherosclerosis and its complications. Ninthly atroscholorotic patients with age>30 years, will be recruited from Emam Reza clinic in Shiraz, Iran. The patients will be randomly divided into 3 groups based on block randomization protocol: treatment group 1 will received3000 mg Conjugated linoleic acid as a 3 Soft gel capsules per day for eight weeks; treatment group 2 will take 1920 mg omega3 fatty acids as a 3 Soft gel capsules per day for eight weeks and control group will receive placebo a 3 Soft gel capsules per day for eight weeks. The patients will be followed for two months. At the beginning and 8 weeks after the start of the study, fasting blood samples will be taken. Lipid profile including cholesterol, triglycerides, LDL and HDL before and after the intervention will be compared in study groups
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201103146067N1
Registration date:2011-05-04, 1390/02/14
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-05-04, 1390/02/14
Registrant information
Name
Dr. Mohammad Hasan Eftekhari Eftekhari
Name of organization / entity
School of health and nutrition, Shiraz University of Mediccal Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1725 1004
Email address
h_eftekhari@yahoo.com
Recruitment status
Recruitment complete
Funding source
Shiraz university of medical sciences
Expected recruitment start date
2011-02-11, 1389/11/22
Expected recruitment end date
2011-03-01, 1389/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effect of conjugated linoleic acid and omega 3 fatty acids supplements on lipid profile, inflammatory factors and oxidative stress indices on patients with atherosclerosis
Public title
The effect of conjugated linoleic acid and omega 3 fatty acids on patients with atheroscherosis.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with Atherosclerosis with Age more than30 years old, 24.5>Body Mass Index>18.5, use of stable dosage medication for hyperlipidemia in study period, patients with history of stable angina, heart attack and bypass surgery.
Exclusion criteria:
Having Acute heart failure ، Arrhythmia, Acute complications of atherosclerosis, using any supplement such as vitamin C, E, Omega3 during and six months before the study, pregnancy , UVB exposure with therapeutic goals and diabetes mellitus
Age
From 30 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
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
City
Shiraz
Postal code
Approval date
2011-02-10, 1389/11/21
Ethics committee reference number
89-5407
Health conditions studied
1
Description of health condition studied
Heart disease
ICD-10 code
I25.1
ICD-10 code description
بيماري قلبي آترواسكلروتيك
Primary outcomes
1
Description
Lipid profile
Timepoint
Before and after intervention
Method of measurement
Auto Analysor
Secondary outcomes
1
Description
GSH-X(Glutathione peroxidase)
Timepoint
Before and after intervention
Method of measurement
ELIZA
2
Description
MDA (Malondialdehyde)
Timepoint
Before and after intervention
Method of measurement
Spectrophotometery
3
Description
hs-CRP(high sensetive c-reactive protein)
Timepoint
Before and after intervention
Method of measurement
ELIZA
4
Description
Interleukin 6
Timepoint
Before and after intervention
Method of measurement
RIA kit
Intervention groups
1
Description
Conjugated linoleic acid intake,3000 mg per day, for 2months , 3 capsule per day, each capsule contain 1000mg cnjugated linoleic acid
Category
Treatment - Drugs
2
Description
Omega 3 fatty acids intake,1920mg per day for 2 months , 3 capsule per day, each capsule contain 640 mg,omega3 fatty acids
Category
Treatment - Drugs
3
Description
Placebo intake for 2 months , 3 capsule per day
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza clinic
Full name of responsible person
Street address
City
shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz university of medical sciences
Full name of responsible person
Dr. Mohammad Hossein Dabaghmanesh
Street address
Shiraz university of medical sciences
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 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
School of health and nutrition, Shiraz University of Mediccal Sciences
Full name of responsible person
fereshte aliasghari
Position
MSc. student of nutrition
Other areas of specialty/work
Street address
Department of nutrition, School of health and nutrition, Shiraz University of Mediccal Sciences
City
shiraz
Postal code
7153675541
Phone
+98 71 1725 1001
Fax
+98 71 1726 0225
Email
f.aliasghary@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of health and nutrition, Shiraz University of Mediccal Sciences
Full name of responsible person
Dr. Mohammad Hassan Eftekhari
Position
PHD of nutrition,associate professor of nutrition department
Other areas of specialty/work
Street address
Department of nutrition, School of health and nutrition, Shiraz University of Mediccal Sciences
City
Shiraz
Postal code
7153675541
Phone
+98 71 1725 1001
Fax
+98 71 1726 0225
Email
eftekharim@sums.ac.ir; h_efftekhari@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz Universoty of Medical Sciences
Full name of responsible person
fereshte aliasghari
Position
MSc student
Other areas of specialty/work
Street address
Shiraz, Shiraz Universoty of Medical Sciences, School of health and nutrition
City
Shiraz
Postal code
Phone
Fax
Email
f.aliasghary@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)