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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 BDNF، Follistatin، Irisin 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 BDNF، Follistatin، Irisin 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CVD, Placebo | Placebo Comparator | patients with cardiovascular disease who receive 4 cap of placebo/day |
|
| CVD, Omega-3 | Active Comparator | patients with Cardiovascular disease who receive 4g/d omega-3 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omega-3 | Dietary Supplement | 4 cap 1 g Omega-3 per day for 2 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Serum Irisin | Change from baseline at 2 months | |
| Serum Brain-Derived Neurotrophic Factor(BDNF) | Change from baseline at 2 months | |
| Serum Follistatin | Change frome baseline at 2 months | |
| Serum Myostatin | Change from baseline at 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Serum high-sensitivity C-reactive protein (hsCRP) | Change from baseline at 2 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mohammad Hasan Javanbakht, MD, Ph.D | Department of Nutrition & Biochemistry, School of Public Health, Tehran University of Medical Sciences (TUMS) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tehran University of Medical Sciences | Tehran | Iran |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D004281 | Docosahexaenoic Acids |
| D015525 | Fatty Acids, Omega-3 |
| ID | Term |
|---|---|
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
| D008055 | Lipids |
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| Placebo | Dietary Supplement | 4 cap 1 g Placebo(paraffin) per day for 2 months |
|
| D005231 |
| Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D005395 | Fish Oils |
| D009821 | Oils |