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

Coronary Artery Disease Clinical Trial

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02011906
• Other study ID #: 95983
• Status: Enrolling by invitation
• Phase: Phase 4
• First received: December 10, 2013
• Last updated: December 10, 2013
• Start date: October 2013
• Est. completion date: August 2015

Study information

• Verified date: December 2013
• Source: Tehran University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 20
• Est. completion date: August 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 45 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Dietary Supplement:
• omega 3

• vitamin E

• placebo of omega 3

• placebo of vitamin E

Locations

Country	Name	City	State
Iran, Islamic Republic of	Tehran University of Medical Sciences	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Tehran University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	serum total cholesterol		change from baseline at 2 months	No
Primary	serum HDL cholesterol		change from baseline at 2 months	No
Primary	serum triglycerides level		change from baseline at 2 months	No
Primary	serum LDL cholesterol		change from baseline at 2 months	No
Primary	serum insulin		change from baseline at 2 months	No
Primary	serum Hs-CRP		change from baseline at 2 months	No
Primary	serum gluthatione peroxidase		change from baseline at 2 months	No
Primary	serum catalase		change from baseline at 2 months	No
Primary	serum superoxide dismutase		change from baseline at 2 months	No
Primary	serum total antioxidant capacity		change from baseline at 2 months	No
Secondary	gene expression of SIRT1		change from baseline at 2 months	No
Secondary	gene expression of SIRT3		change from baseline at 2 months	No
Secondary	gene expression of SIRT6		change from baseline at 2 months	No
Secondary	gene expression of PGC-1a		change from baseline at 2 months	No
Secondary	gene expression of FOXO3a		change from baseline at 2 months	No
Secondary	gene expression of FOXO1		change from baseline at 2 months	No
Secondary	gene expression of h TERT		change from baseline at 2 months	No