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

Cardiovascular Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02092584
• Other study ID #: 5144
• Status: Completed
• Phase: Phase 4
• First received: March 18, 2014
• Last updated: March 18, 2014
• Start date: December 2011
• Est. completion date: October 2013

Study information

• Verified date: March 2014
• Source: Tehran University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: October 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 45 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases

Intervention

Dietary Supplement:
• Omega-3
4 cap 1 g Omega-3 per day for 2 months
• Placebo
4 cap 1 g Placebo(paraffin) per day for 2 months

Locations

Country	Name	City	State
Iran, Islamic Republic of	Tehran University of Medical Sciences	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Tehran University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum Total Cholesterol		Change from baseline at 2 months	No
Primary	Serum HDL-C		Change frome baseline at 2 months	No
Primary	Serum LDL-C		Change frome baseline at 2 months	No
Primary	Serum TG		Change frome baseline at 2 months	No
Primary	Serum Fasting Blood Sugar(FBS)		Change frome baseline at 2 months	No
Primary	Serum Insulin		Change frome baseline at 2 months	No
Primary	Serum hsCRP		Change frome baseline at 2 months	No
Primary	Serum Insulin Like Growth Factor-1(IGF-1)		Change frome baseline at 2 months	No
Primary	Serum IGF binding protein 3(IGFBP-3)		Change frome baseline at 2 months	No
Secondary	Gene Expression of IGF-1		Change frome baseline at 2 months	No
Secondary	Gene expression of IGFBP3		change from baseline at 2 months	No