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

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

Study Overview

• Status: Unknown
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Dietary supplement: omega 3; Dietary supplement: placebo of vitamin E; Dietary supplement: vitamin E; Dietary supplement: placebo of omega 3

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 4

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Tehran, Iran, Islamic Republic of
    • Tehran University of Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / 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 vitamin E; Dietary supplement: placebo of omega 3

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Tehran University of Medical Sciences

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Anticipated): April 1, 2015
• Study Completion (Anticipated): August 1, 2015

Study Registration Dates

• First Submitted: December 10, 2013
• First Submitted That Met QC Criteria: December 10, 2013
• First Posted (Estimate): December 13, 2013

Study Record Updates

• Last Update Posted (Estimate): December 13, 2013
• Last Update Submitted That Met QC Criteria: December 10, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Keywords: omega 3; CAD; vitamin E; Sirtuins; antioxidant enzymes; FOXOs
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Micronutrients; Antioxidants; Vitamin E; Tocopherols; alpha-Tocopherol; Vitamins; Tocotrienols
• Other Study ID Numbers: 95983