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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

NCT ID: NCT02011906

Last Updated: 2013-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2015-08-31

Brief Summary

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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

Detailed Description

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Conditions

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Coronary Artery Disease

Keywords

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antioxidant enzymes omega 3 vitamin E CAD Sirtuins FOXOs

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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

Group Type ACTIVE_COMPARATOR

omega 3

Intervention Type DIETARY_SUPPLEMENT

placebo of vitamin E

Intervention Type DIETARY_SUPPLEMENT

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

Group Type ACTIVE_COMPARATOR

omega 3

Intervention Type DIETARY_SUPPLEMENT

vitamin E

Intervention Type DIETARY_SUPPLEMENT

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

Group Type PLACEBO_COMPARATOR

placebo of omega 3

Intervention Type DIETARY_SUPPLEMENT

placebo of vitamin E

Intervention Type DIETARY_SUPPLEMENT

Interventions

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omega 3

Intervention Type DIETARY_SUPPLEMENT

vitamin E

Intervention Type DIETARY_SUPPLEMENT

placebo of omega 3

Intervention Type DIETARY_SUPPLEMENT

placebo of vitamin E

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Tehran University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Tehran University of Medical Sciences

Tehran, , Iran

Site Status

Countries

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Iran

Other Identifiers

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95983

Identifier Type: -

Identifier Source: org_study_id