Flaxseed Consumption, Alone and in Combination With the Mediterranean-like Diet, on Some Indicators Related to Atherosclerosis

Study Overview
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Brief Summary
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Flaxseed consumption has beneficial effects on cardiovascular risk factors. In addition, the benefit of the Mediterranean-like diet in primary and secondary prevention of cardiovascular diseases has been shown.The purpose of this study is to investigate the effects of flaxseed consumption, alone and in combination with the Mediterranean-like diet, in adjunct to conventional medical treatment, in improving vascular endothelial function, plasma lipid profile and high sensitivity c-reactive protein of coronary artery disease (CAD) patients.

Detailed Description
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A randomized placebo controlled clinical trial will be conducted in Rajaie Cardiovascular Center in Tehran, Iran. After review of the inclusion and exclusion criteria and explanation of the design of the study, written consent form will be completed. The participants are 81 eligible coronary artery disease patients, aged 20-75 years. Intervention groups will be received 30 g/d flaxseed, alone, or with weekly Mediterranean-like diet menu and control group will be received capsules of wheat fiber as placebo for 3 months. Vascular endothelial function will be evaluated through measurement of flow mediated dilatation (FMD) in brachial artery and carotid intima-media thickness (c-IMT) via ultrasound sonography and plasma level of asymmetric di-methyl arginine (ADMA). Fasting blood sample will be taken to measure malondialdehyde (MDA), lipid profile, high sensitive C-reactive protein and inflammatory cytokines (Interleukine-6 [IL-6] and Tumor Necrosis Factor-a [TNF-a]).

Official Title
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Effects of Flaxseed Consumption, Alone and in Combination With the Mediterranean-like Diet, on Vascular Endothelial Function and Some Biochemical Indicators Related to Atherosclerosis in Patients With Coronary Artery Disease

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Other: Flaxseed
* Other: the Mediterranean-like diet
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: coronary artery disease patients (more than 50% blockage in coronary arteries) needed angioplasty with stent willing to participation in the study Exclusion Criteria: cigarette Smoking continuous consumption of any antioxidant supplement such as vitamin E, vitamin C and Selenium in last month consumption of flaxseed or any omega-3 supplement at the beginning of the study َadvanced renal disease unwillingness to continuance any change in disease treatment plan such as change in type and dose of lipid lowering drugs or surgical operation

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Flaxseed<br>Daily consumption of 30 grams flaxseed for 3 months | Other: Flaxseed<br>* Daily consumption of 30 grams flaxseed in adjunct to medical treatment for 3 months<br>|
| Active Comparator: Flaxseed and the Mediterranean-like diet<br>Daily consumption of 30 grams flaxseed in adjunct to the Mediterranean-like diet for 3 months | Other: Flaxseed<br>* Daily consumption of 30 grams flaxseed in adjunct to medical treatment for 3 months<br>Other: the Mediterranean-like diet<br>* Weekly Mediterranean-like diet menu in adjunct to medical treatment for 3 months<br>|
| Placebo Comparator: Placebo<br>Daily consumption of Placebo for 3 months | Dietary Supplement: Placebo<br>* Daily consumption of one capsule of wheat fiber as placebo in adjunct to medical treatment for 3 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Flow Mediated Dilatation (FMD) | Change in dilatation of the brachial artery from baseline at 3 month | 3 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| plasma level of high sensitive C reactive protein (hs-CRP) | change in plasma level of high sensitive C reactive protein (hs-CRP) from baseline at 3 month | 3 month | 
| plasma lipid profile | change in plasma level of lipid profile from baseline at 3 month | 3 month | 
| carotid intima-media thickness (c-IMT) | change in carotid intima-media thickness from baseline at 3 month | 3 month | 
| asymmetric di-methyl arginine (ADMA) | change in plasma level of assymetric di-methyl arginine from baseline at 3 month | 3 month |