A Phase 4 interventional study of Omega-3 and Placebo in Cardiovascular Disease, sponsored by Tehran University of Medical Sciences. Completed at 1 site in Iran, Islamic Republic of. Open to male participants aged 45 Years to 65 Years. Per ClinicalTrials.gov, last updated 2015-04-08.
Sponsored by Tehran University of Medical Sciences · Phase 4, Interventional, and Treatment
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 BMP-4, YKL40, HSP70, HSP27 in patients 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 BMP-4, YKL40, HSP70, HSP27 in patients with cardiovascular disease. In this randomized, double-blind clinical trial, placebo-controlled, single-center, and phase two trials, 42men aged 45-65 years with Coronary Artery Disease are enrolled in the study from Tehran Heart Center. After signing informed consent all individuals complete a general information form , 24-hour food recall for 3 days will be taken from the participants at the beginning and the end of the study,. Selected samples are randomly classified into 2 blocks of groups receiving supplement and placebo. The supplement group, will receive 4 g/day omega 3 fatty acid for 8 weeks and the placebo group will also receive placebo (containing 4 g of edible paraffin) (similar in terms of color, shape and size). Patients are recommended to sustain their diets and medication dose (s) during the study and also advised to maintain a constant level of physical activity. Blood samples will be collected after 8-12 hours fasting and anthropometric variables, biochemical parameters and physical activity before and after the trial will be measured.
4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.
This study's enrollment of 21 is below the median of 100 across 2,738 interventional studies indexed under Cardiovascular Diseases.
Browse Cardiovascular Diseases studies →Tehran University of Medical Sciences is the lead sponsor of 227 studies on the registry; 12 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
patients with Cardiovascular disease who receive 4g/d omega-3
Dietary Supplement: Omega-3
patients with cardiovascular disease who receive 4 cap of placebo/day
Dietary Supplement: Placebo
4 cap 1 g Omega-3 per day for 2 months
Also known as: n-3 fatty acids, n-3 PUFA
4 cap 1 g Placebo(paraffin) per day for 2 months
Serum Heat Shock Protein 70(HSP70)
Time frame: Change frome baseline at 2 months
Serum Ox-LDL
Time frame: Change frome baseline at 2 months
Serum BMP4 (Bone Morphogenic Protein4)
Time frame: Change frome baseline at 2 months
Serum Heat Shock Protein 27(HSP27)
Time frame: Change frome baseline at 2 months
Serum YKL40
Time frame: Change frome baseline at 2 months
Serum hsCRP
Time frame: Change frome baseline at 2 months
This study is completed, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.
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Tehran University of Medical Sciences