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

NCT02011906 | Unknown Phase 4 DMC

• 1 other identifier: 95983
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Coronary Artery Disease

Keywords

antioxidant enzymes; omega 3; vitamin E; CAD; Sirtuins; FOXOs

Outcome Measures

Primary Outcomes (10)

• 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 Outcomes (7)

• 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

Study Arms (3)

CAD, OMEGA 3

ACTIVE COMPARATOR

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

CAD, omega 3 and vitamin E

ACTIVE COMPARATOR

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

CAD, placebo

PLACEBO COMPARATOR

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

Interventions

omega 3 DIETARY_SUPPLEMENT

CAD, OMEGA 3; CAD, omega 3 and vitamin E

vitamin E DIETARY_SUPPLEMENT

CAD, omega 3 and vitamin E

placebo of omega 3 DIETARY_SUPPLEMENT

CAD, placebo

placebo of vitamin E DIETARY_SUPPLEMENT

CAD, OMEGA 3; CAD, placebo

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tehran University of Medical Sciences: lead

Study Sites (1)

Tehran University of Medical Sciences

Tehran, Iran

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Docosahexaenoic Acids; Vitamin E

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2013
• First Posted: December 13, 2013
• Study Start: October 1, 2013
• Primary Completion: April 1, 2015
• Study Completion: August 1, 2015
• Last Updated: December 13, 2013

Record last verified: 2013-12

Locations

IR (1)