Effect of Omega-3 Supplementation on Serum Level and Gene Expression of IGF-1and IGFBP-3 in Men With CVD.

NCT ID: NCT02092584

Last Updated: 2014-03-20

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

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2013-10-31

Brief Summary

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The aim of this study is the comparison between the effects of supplementation with omega 3 or placebo for 8 weeks in serum level of IGF-1 and IGFBP-3 and gene expression of IGF-1 in patients with cardiovascular disease.

Detailed Description

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Conditions

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Cardiovascular Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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CVD, Omega-3

patients with Cardiovascular disease who receive 4g/d omega-3

Group Type ACTIVE_COMPARATOR

Omega-3

Intervention Type DIETARY_SUPPLEMENT

4 cap 1 g Omega-3 per day for 2 months

CVD, Placebo

patients with cardiovascular disease who receive 4 cap of placebo/day

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

4 cap 1 g Placebo(paraffin) per day for 2 months

Interventions

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Omega-3

4 cap 1 g Omega-3 per day for 2 months

Intervention Type DIETARY_SUPPLEMENT

Placebo

4 cap 1 g Placebo(paraffin) per day for 2 months

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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n-3 fatty acids n-3 PUFA

Eligibility Criteria

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Inclusion Criteria

* CVD patients 45- 65 years old, patients with ≥ 50% stenosis in at least one coronary angiogram demonstrated, body mass index in the range 18.5- 35, avoidance of dietary supplements, vitamins and herbal products at least 3 months before and throughout the intervention, willingness to participation,

Exclusion Criteria

* people who have used omega 3 supplements in last 3 months, having chronic renal disease , GI disease, hepatobiliary diseases, hematological disorders, hypo- or hyperthyroidism, 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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5144

Identifier Type: -

Identifier Source: org_study_id

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