Assessing the Effects of Omega-3 Supplementation on Some Serum BDNF، Follistatin، Irisin Levels in Men With CAD

Study Overview
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Brief Summary
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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.

Detailed Description
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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. 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.

Official Title
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Assessing the Effects of Omega-3 Supplementation on Some Serum BDNF، Follistatin، Irisin Levels in Men With Coronary Artery Disease

Conditions
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Cardiovascular Disease

Intervention / Treatment
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* Dietary Supplement: Omega-3
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: cardiovascular disease 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, movement disorders, myopathy , hypo- or hyperthyroidism, Smokers

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: CVD, Placebo<br>patients with cardiovascular disease who receive 4 cap of placebo/day | Dietary Supplement: Placebo<br>* 4 cap 1 g Placebo(paraffin) per day for 2 months<br>|
| Active Comparator: CVD, Omega-3<br>patients with Cardiovascular disease who receive 4g/d omega-3 | Dietary Supplement: Omega-3<br>* 4 cap 1 g Omega-3 per day for 2 months<br>* Other names: n-3 PUFA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum high-sensitivity C-reactive protein (hsCRP) |  | Change from baseline at 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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atherosclerotic, BDNF, Follistatin, Irisin