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

Phase 4

Completed

• Conditions: Cardiovascular Disease
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Omega-3

• Registration Number: NCT02092584
• Lead Sponsor: Tehran University of Medical Sciences

Brief Summary

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

Not available

Study Timeline

• Study Start: 2011-12
• Primary Completion: 2013-08
• Study Completion: 2013-10
• Status Verified: 2014-03
• Study First Submitted: 2014-03-18
• Study First Submitted QC: 2014-03-18
• Last Update Submitted: 2014-03-18
• Study First Posted: 2014-03-20
• Last Update Posted: 2014-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 31

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CVD, Placebo	Placebo	patients with cardiovascular disease who receive 4 cap of placebo/day
CVD, Omega-3	Omega-3	patients with Cardiovascular disease who receive 4g/d omega-3

Primary Outcome Measures

Name	Time	Method
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
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

Secondary Outcome Measures

Name	Time	Method
Gene Expression of IGF-1	Change frome baseline at 2 months
Gene expression of IGFBP3	change from baseline at 2 months

Trial Locations

Locations (1)

Tehran University of Medical Sciences; 🇮🇷 Tehran, Iran, Islamic Republic of