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

Study Overview
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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.

Official Title
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Effect of Omega-3 Supplementation on Serum Level and Gene Expression of IGF-1and IGFBP-3 in Men With Cardiovascular Disease.

Conditions
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Cardiovascular Disease

Intervention / Treatment
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* Dietary Supplement: Omega-3
* Dietary Supplement: Placebo


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CVD, Omega-3<br>patients with Cardiovascular disease who receive 4g/d omega-3 | Dietary Supplement: Omega-3<br>* 4 cap 1 g Omega-3 per day for 2 months<br>* Other names: n-3 PUFA;|
| Placebo Comparator: CVD, Placebo<br>patients with cardiovascular disease who receive 4 cap of placebo/day | Dietary Supplement: Placebo<br>* 4 cap 1 g Placebo(paraffin) per day for 2 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum Total Cholesterol |  | Change from baseline at 2 months | 
| Serum HDL-C |  | Change frome baseline at 2 months | 
| Serum LDL-C |  | Change frome baseline at 2 months | 
| Serum TG |  | Change frome baseline at 2 months | 
| Serum Fasting Blood Sugar(FBS) |  | Change frome baseline at 2 months | 
| Serum Insulin |  | Change frome baseline at 2 months | 
| Serum hsCRP |  | Change frome baseline at 2 months | 
| Serum Insulin Like Growth Factor-1(IGF-1) |  | Change frome baseline at 2 months | 
| Serum IGF binding protein 3(IGFBP-3) |  | Change frome baseline at 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gene Expression of IGF-1 |  | Change frome baseline at 2 months | 
| Gene expression of IGFBP3 |  | change from baseline at 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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atherosclerotic, IGF-1, IGFBP-3