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

Tehran University of Medical Sciences

Status and phase: Completed; Phase 4

Conditions: Cardiovascular Disease

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Omega-3

Study type: Interventional

Funder types: Other

Identifiers

NCT02092584

5144

Details and patient eligibility

About

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.

Enrollment: 31 patients

Sex: Male

Ages: 45 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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31 participants in 2 patient groups, including a placebo group

CVD, Omega-3

Active Comparator group

Description:

patients with Cardiovascular disease who receive 4g/d omega-3

Treatment:

Dietary Supplement: Omega-3

CVD, Placebo

Placebo Comparator group

Description:

patients with cardiovascular disease who receive 4 cap of placebo/day

Treatment:

Dietary Supplement: Placebo