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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

Primary Purpose

Coronary Artery Disease

Status
Unknown status
Phase
Phase 4
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
omega 3
vitamin E
placebo of omega 3
placebo of vitamin E
Sponsored by
Tehran University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring antioxidant enzymes, omega 3, vitamin E, CAD, Sirtuins, FOXOs

Eligibility Criteria

45 Years - 65 Years (Adult, Older Adult)MaleDoes not accept 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

Sites / Locations

  • Tehran University of Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

CAD, OMEGA 3

CAD, omega 3 and vitamin E

CAD, placebo

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

serum total cholesterol
serum HDL cholesterol
serum triglycerides level
serum LDL cholesterol
serum insulin
serum Hs-CRP
serum gluthatione peroxidase
serum catalase
serum superoxide dismutase
serum total antioxidant capacity

Secondary Outcome Measures

gene expression of SIRT1
gene expression of SIRT3
gene expression of SIRT6
gene expression of PGC-1a
gene expression of FOXO3a
gene expression of FOXO1
gene expression of h TERT

Full Information

First Posted
December 10, 2013
Last Updated
December 10, 2013
Sponsor
Tehran University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02011906
Brief Title
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 Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Unknown status
Study Start Date
October 2013 (undefined)
Primary Completion Date
April 2015 (Anticipated)
Study Completion Date
August 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tehran University of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
antioxidant enzymes, omega 3, vitamin E, CAD, Sirtuins, FOXOs

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CAD, OMEGA 3
Arm Type
Active Comparator
Arm Description
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
Arm Title
CAD, omega 3 and vitamin E
Arm Type
Active Comparator
Arm Description
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
Arm Title
CAD, placebo
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
omega 3
Intervention Type
Dietary Supplement
Intervention Name(s)
vitamin E
Intervention Type
Dietary Supplement
Intervention Name(s)
placebo of omega 3
Intervention Type
Dietary Supplement
Intervention Name(s)
placebo of vitamin E
Primary Outcome Measure Information:
Title
serum total cholesterol
Time Frame
change from baseline at 2 months
Title
serum HDL cholesterol
Time Frame
change from baseline at 2 months
Title
serum triglycerides level
Time Frame
change from baseline at 2 months
Title
serum LDL cholesterol
Time Frame
change from baseline at 2 months
Title
serum insulin
Time Frame
change from baseline at 2 months
Title
serum Hs-CRP
Time Frame
change from baseline at 2 months
Title
serum gluthatione peroxidase
Time Frame
change from baseline at 2 months
Title
serum catalase
Time Frame
change from baseline at 2 months
Title
serum superoxide dismutase
Time Frame
change from baseline at 2 months
Title
serum total antioxidant capacity
Time Frame
change from baseline at 2 months
Secondary Outcome Measure Information:
Title
gene expression of SIRT1
Time Frame
change from baseline at 2 months
Title
gene expression of SIRT3
Time Frame
change from baseline at 2 months
Title
gene expression of SIRT6
Time Frame
change from baseline at 2 months
Title
gene expression of PGC-1a
Time Frame
change from baseline at 2 months
Title
gene expression of FOXO3a
Time Frame
change from baseline at 2 months
Title
gene expression of FOXO1
Time Frame
change from baseline at 2 months
Title
gene expression of h TERT
Time Frame
change from baseline at 2 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Tehran University of Medical Sciences
City
Tehran
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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