The effect of Supplemetation of ω3 and its combination with Vitamin E on gene expressions of adiponectin and its receptors in men’s PBMC with Coronary Artery Disease(CAD).
In this study refer to the heart hospital TEHRAN, 60 man contracted the disease and vascular heart disease, with shortness of breath more than 50% in at least one of the veins has been proved كرونری with angiography in three months and according to recent arrival with the criteria will be selected and then at random to three groups receiving the Supplement ω 3 and the group receiving the combined supplement ω 3 and vitamin E and placebo group . Of these patients 10 cc venous blood sample is taken and then weight of each patient with patient consent in clothes and without shoes, so around the waist with the use of the feet which entails measurements is also remembered 24 hour food in patients beginning and end study complete. patients will receive for 8 weeks 4 day hot Omega 3 and vitamin e gel capsule to form soft (softgel). blood cellswere taken from patients in the beginning and end study and will separate and were measured gene expression of PPAR γ and adiponectin and its receptors in PBMC in patients. Also Serum criteria before and after eight weeks of intervention a AND THEN comparison in the groups will be done with the use of software of Nutritionist 4.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013080514273N1
Registration date:2013-08-13, 1392/05/22
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-08-13, 1392/05/22
Registrant information
Name
Mahmoud Jalali
Name of organization / entity
Faculty of Nutrition. Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8895 4911
Email address
jalalikh87@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences, School of Nutrition
Tehran Heart Hospital
Expected recruitment start date
2013-05-22, 1392/03/01
Expected recruitment end date
2013-07-23, 1392/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Supplemetation of ω3 and its combination with Vitamin E on gene expressions of adiponectin and its receptors in men’s PBMC with Coronary Artery Disease(CAD).
Public title
The effect of Supplemetation of ω3 and its combination with Vitamin E in Coronary Artery Disease(CAD).
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
BMI less than 30
aged 65-45 years
More than 50% of patients with at least one coronary artery stenosis confirmed by angiography in three months
Lack of PPARγ agonist drugs such Tyazvlydyn Dion (TZDs), and fiber and taking angiotensin receptor type 1 blockers and inhibitors of non-ACE,
willingness to cooperate
Criteria excluded:
kidney disease, liver disease, diabetes, cancer, thyroid disorders, according to the patient's medical history
smoking (at least 5 threads in the last 6 months)
omega-3 supplements or fish oil and vitamin E for three months
Allergy and sensitivity to fish oil
Lack of cooperation is likely to continue.
Mbar excluded
Any drastic changes in diet (the doctor, the patient himself)
Age
From 45 years old to 65 years old
Gender
Male
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
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences Ethics Committee
Street address
Keshavarz Blvd, corner of Ghods St.
City
tehran
Postal code
Approval date
2013-07-31, 1392/05/09
Ethics committee reference number
86686
Health conditions studied
1
Description of health condition studied
coronary artery Disease
ICD-10 code
I25.1
ICD-10 code description
Atherosclerotic heart disease
Primary outcomes
1
Description
gene expression of adiponectin in PBMC
Timepoint
Baseline, After8 weeks
Method of measurement
Realtime PCR
2
Description
gene expression of adiponectin receptors , R1 and R2 in PBMC
Timepoint
Baseline , after 8 weeks
Method of measurement
Realtime PCR
3
Description
gene expression of PPAR gamma in PBMC
Timepoint
Baseline , after 8 weeks
Method of measurement
Realtime PCR
4
Description
serum A-FABP
Timepoint
Baseline , after 8 weeks
Method of measurement
ELISA
5
Description
serum hs-CRP
Timepoint
Baseline , after 8 weeks
Method of measurement
ELISA
6
Description
serum adiponectin
Timepoint
Baseline , after 8 weeks
Method of measurement
ELISA
7
Description
adiponectin / A-FABP
Timepoint
Baseline , after 8 weeks
Method of measurement
Calculate
8
Description
Systolic Blood pressure
Timepoint
Baseline , after 8 weeks
Method of measurement
Mercury Sphygmomanometer
9
Description
Diastolic Blood pressure
Timepoint
Baseline , after 8 weeks
Method of measurement
Mercury Sphygmomanometer
Secondary outcomes
1
Description
serum cratinine
Timepoint
baseline, after 8 weeks
Method of measurement
ELISA
2
Description
waist cirumfrence
Timepoint
baseline, after 8 weeks
Method of measurement
meter
3
Description
hip cirumfrence
Timepoint
baseline, after 8 weeks
Method of measurement
meter
4
Description
serum fasting glucose
Timepoint
baseline, after 8 weeks
Method of measurement
Autoanalyser
5
Description
serum triglyceride
Timepoint
baseline, after 8 weeks
Method of measurement
Autoanalyser
6
Description
serum total cholesterol
Timepoint
baseline, after 8 weeks
Method of measurement
Autoanalyser
7
Description
Low density lipoprotein
Timepoint
baseline, after 8 weeks
Method of measurement
Autoanalyser
8
Description
high Density Lipoprotein
Timepoint
baseline, after 8 weeks
Method of measurement
Autoanalyser
9
Description
Body Composition
Timepoint
baseline, after 8 weeks
Method of measurement
BIA
10
Description
height
Timepoint
Baseline
Method of measurement
meter
11
Description
weight
Timepoint
baseline, after 8 weeks
Method of measurement
Weighing scales
12
Description
Body mass index(BMI)
Timepoint
baseline, after 8 weeks
Method of measurement
calculate
13
Description
24 hours recall
Timepoint
baseline, after 8 weeks
Method of measurement
Questionnaire
Intervention groups
1
Description
Intervention group: receiving omega 3 capsule (two 2 gr capsule two times daily, total 4 gr) for 8 weeks
Category
Treatment - Drugs
2
Description
Intervention group: receiving omega 3 capsule (two 2 gr capsule two times daily, total 4 gr) and 1 capsule vitamin E(400 IU)for 8 weeks
Category
Treatment - Drugs
3
Description
control group: receiving placebo capsule contain: omega 3 placebo capsule (two 2 gr capsule two times daily, total 4 gr) and 1 placebo of vitamin E(400 IU)for 8 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran Heart Hospital
Full name of responsible person
Atena Ramezani
Street address
tehran -kargar St
City
tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
tehran university of medical sciences
Full name of responsible person
Dr. Akbar Fotoohi
Street address
Vice-chancellor for Research, 6th floor, Tehran University of Medical Sciences, Central building, Keshavarz blvd.
City
tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
tehran 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
Depatment of Cellular And Molecular Nutrition, Tehran University of Medical Sciences
Full name of responsible person
Atena Ramezani
Position
ph.D student of Nutrition
Other areas of specialty/work
Street address
Nutrition Department, Health Faculty, Tehran University of Medical Sciences, Poorsina street
City
tehran
Postal code
Phone
+218 8954911
Fax
Email
ramezaniatena@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Depatment of cellular and molecular Nutrition, Tehran University of Medical Sciences
Full name of responsible person
Dr. Mahmoud Jalali
Position
Professor of Biochemistry/PhD
Other areas of specialty/work
Street address
Nutrition and Biochemistry Department, Health Faculty, Tehran University of Medical Sciences, Poorsina Street
City
tehran
Postal code
00982188974463
Phone
+98 21 8895 4911
Fax
Email
jalalimahmoud@hotmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Atena Ramezani
Position
ph.D student of Nutrition
Other areas of specialty/work
Street address
Nutrition and biochemistry Department, 4th floor, Health Faculty, Poorsina street
City
Tehran
Postal code
Phone
+98 21 8895 4911
Fax
+98 21 8897 4462
Email
ramezani_a@razi.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)