The Effects of Omega 3 and Vitamin E Supplementation on the Serum Antioxidant Enzymes and Gene Expressions of PGC-1a, h TERT, FOXOs and SIRTs in CAD Patients

Study Overview
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Brief Summary
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The aim of this study is to determine the effects of omega 3 supplementation and its concurrent supplementation with vitamin E on the serum levels of antioxidant enzymes and the expressions of the PGC-1a, h TERT, FOXO1, FOXO3a , SIRT1,SIRT3, SIRT6 genes in PBMC cells in the patients with coronary artery disease

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Dietary Supplement: omega 3
* Dietary Supplement: vitamin E
* Dietary Supplement: placebo of omega 3
* Dietary Supplement: placebo of vitamin E


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - literate, willingness to participation, CAD patients 45- 65 years old, body mass index< 30, avoidance of dietary supplements, vitamins and herbal products at least 3 months before and throughout the intervention, willing to maintain body weight during the study Exclusion Criteria: people who have used vitamin E or omega 3 supplements in last 3 months, having chronic renal disease ,cancer, Hepatobilliary diseases, hematological disorders, hypo- or hyperthyroidism, diabetes, treatment with PPAR-gamma agonists or Thiazolidinediones, Smokers

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CAD, OMEGA 3<br>patients with CAD who receive 4 gr/day omega 3 in the form of 4 softgels each of them contains 1000 mg omega 3 and a softgel contains placebo of vitamin E | Dietary Supplement: omega 3<br> <br> Dietary Supplement: placebo of vitamin E<br> <br> |
| Active Comparator: CAD, omega 3 and vitamin E<br>patients with CAD who receive 4 gr/day omega 3 in the form of 4 softgels each of them contains 1000 mg omega 3 and a softgel contains 400 IU vitamin E | Dietary Supplement: omega 3<br> <br> Dietary Supplement: vitamin E<br> <br> |
| Placebo Comparator: CAD, placebo<br>patients with CAD who receive 4 softgels/day each of them contains placebo of omega 3 and a softgel/day contains placebo of vitamin E | Dietary Supplement: placebo of omega 3<br> <br> Dietary Supplement: placebo of vitamin E<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum total cholesterol |  | change from baseline at 2 months | 
| serum HDL cholesterol |  | change from baseline at 2 months | 
| serum triglycerides level |  | change from baseline at 2 months | 
| serum LDL cholesterol |  | change from baseline at 2 months | 
| serum insulin |  | change from baseline at 2 months | 
| serum Hs-CRP |  | change from baseline at 2 months | 
| serum gluthatione peroxidase |  | change from baseline at 2 months | 
| serum catalase |  | change from baseline at 2 months | 
| serum superoxide dismutase |  | change from baseline at 2 months | 
| serum total antioxidant capacity |  | change from baseline at 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| gene expression of SIRT1 |  | change from baseline at 2 months | 
| gene expression of SIRT3 |  | change from baseline at 2 months | 
| gene expression of SIRT6 |  | change from baseline at 2 months | 
| gene expression of PGC-1a |  | change from baseline at 2 months | 
| gene expression of FOXO3a |  | change from baseline at 2 months | 
| gene expression of FOXO1 |  | change from baseline at 2 months | 
| gene expression of h TERT |  | change from baseline at 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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antioxidant enzymes, omega 3, vitamin E, CAD, Sirtuins, FOXOs