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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02092584
Enrollment
31
Registered
2014-03-20
Start date
2011-12-31
Completion date
2013-10-31
Last updated
2014-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Disease

Keywords

atherosclerotic, IGF-1, IGFBP-3

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.

Interventions

DIETARY_SUPPLEMENTOmega-3

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

DIETARY_SUPPLEMENTPlacebo

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

Sponsors

Tehran University of Medical Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
MALE
Age
45 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Serum IGF binding protein 3(IGFBP-3)Change frome baseline at 2 months
Serum hsCRPChange frome baseline at 2 months
Serum Insulin Like Growth Factor-1(IGF-1)Change frome baseline at 2 months
Serum Total CholesterolChange from baseline at 2 months
Serum HDL-CChange frome baseline at 2 months
Serum LDL-CChange frome baseline at 2 months
Serum TGChange frome baseline at 2 months
Serum Fasting Blood Sugar(FBS)Change frome baseline at 2 months
Serum InsulinChange frome baseline at 2 months

Secondary

MeasureTime frame
Gene expression of IGFBP3change from baseline at 2 months
Gene Expression of IGF-1Change frome baseline at 2 months

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026