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OpenTrials
Completed

NCT Number: NCT02092584

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

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.

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Key information

Conditions

Cardiovascular Disease Cardiovascular Diseases

Age range

45 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Tehran University of Medical Sciences

Tehran, Iran

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Omega-3

Dietary Supplement

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

Other names: n-3 fatty acids, n-3 PUFA

Placebo

Dietary Supplement

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

Primary outcomes

  1. Serum Total Cholesterol

    Time frame: Change from baseline at 2 months

  2. Serum HDL-C

    Time frame: Change frome baseline at 2 months

  3. Serum LDL-C

    Time frame: Change frome baseline at 2 months

  4. Serum TG

    Time frame: Change frome baseline at 2 months

  5. Serum Fasting Blood Sugar(FBS)

    Time frame: Change frome baseline at 2 months

  6. Serum Insulin

    Time frame: Change frome baseline at 2 months

  7. Serum hsCRP

    Time frame: Change frome baseline at 2 months

  8. Serum Insulin Like Growth Factor-1(IGF-1)

    Time frame: Change frome baseline at 2 months

  9. Serum IGF binding protein 3(IGFBP-3)

    Time frame: Change frome baseline at 2 months

Secondary outcomes

  1. Gene Expression of IGF-1

    Time frame: Change frome baseline at 2 months

  2. Gene expression of IGFBP3

    Time frame: change from baseline at 2 months

Sponsors and collaborators

Lead sponsor

Tehran University of Medical Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Mar 20, 2014
Registry last updated
Mar 20, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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