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

Sponsor

Tehran University of Medical Sciences (Other)

Overall Status

Unknown status

CT.gov ID

NCT02011906

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease	Dietary Supplement: omega 3 Dietary Supplement: vitamin E Dietary Supplement: placebo of omega 3 Dietary Supplement: placebo of vitamin E	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Study Start Date :

Oct 1, 2013

Anticipated Primary Completion Date :

Apr 1, 2015

Anticipated Study Completion Date :

Aug 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: CAD, OMEGA 3 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 Dietary Supplement: placebo of vitamin E
Active Comparator: CAD, omega 3 and vitamin E 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 Dietary Supplement: vitamin E
Placebo Comparator: CAD, placebo 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 Dietary Supplement: placebo of vitamin E

Arm

Intervention/Treatment

Active Comparator: CAD, OMEGA 3

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

Dietary Supplement: placebo of vitamin E

Active Comparator: CAD, omega 3 and vitamin E

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

Dietary Supplement: vitamin E

Placebo Comparator: CAD, placebo

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

Dietary Supplement: placebo of vitamin E

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years to 65 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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