Assessing the Effects of Omega-3 Supplementation on Serum HSP27, HSP70, YKL40, BMP-4 Levels in Male Patient With CAD
- Conditions
- Cardiovascular Disease
- Registration Number
- NCT02117960
- Lead Sponsor
- Tehran University of Medical Sciences
- 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 BMP-4, YKL40, HSP70, HSP27 in patients with cardiovascular disease.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 21
- 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,
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Serum Heat Shock Protein 70(HSP70) Change frome baseline at 2 months
- Secondary Outcome Measures
Name Time Method Serum BMP4 (Bone Morphogenic Protein4) Change frome baseline at 2 months Serum Heat Shock Protein 27(HSP27) Change frome baseline at 2 months Serum Ox-LDL Change frome baseline at 2 months Serum YKL40 Change frome baseline at 2 months Serum hsCRP Change frome baseline at 2 months
Trial Locations
- Locations (1)
Tehran University of Medical Sciences
🇮🇷Tehran, Iran, Islamic Republic of
Tehran University of Medical Sciences🇮🇷Tehran, Iran, Islamic Republic of