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

March 18, 2014 updated by: Tehran University of Medical Sciences

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: CVD, Placebo
patients with cardiovascular disease who receive 4 cap of placebo/day
Dietary supplement: Placebo
4 cap 1 g Placebo(paraffin) per day for 2 months
Active Comparator: CVD, Omega-3
patients with Cardiovascular disease who receive 4g/d omega-3
Dietary supplement: Omega-3
4 cap 1 g Omega-3 per day for 2 months
Other Names:
  • n-3 fatty acids
  • n-3 PUFA

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tehran University of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

October 1, 2013

Study Registration Dates

First Submitted

March 18, 2014

First Submitted That Met QC Criteria

March 18, 2014

First Posted (Estimate)

March 20, 2014

Study Record Updates

Last Update Posted (Estimate)

March 20, 2014

Last Update Submitted That Met QC Criteria

March 18, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5144

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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