Coronary Artery Disease
Conditions
Brief summary
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
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 \[TNF-a\]).
Interventions
OTHERFlaxseed
Daily consumption of 30 grams flaxseed in adjunct to medical treatment for 3 months
OTHERthe Mediterranean-like diet
Weekly Mediterranean-like diet menu in adjunct to medical treatment for 3 months
DIETARY_SUPPLEMENTPlacebo
Daily consumption of one capsule of wheat fiber as placebo in adjunct to medical treatment for 3 months
Sponsors
Javad Nasrollahzadeh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. coronary artery disease patients (more than 50% blockage in coronary arteries) needed angioplasty with stent 2. willing to participation in the study
Exclusion criteria
1. cigarette Smoking 2. continuous consumption of any antioxidant supplement such as vitamin E, vitamin C and Selenium in last month 3. consumption of flaxseed or any omega-3 supplement at the beginning of the study 4. َadvanced renal disease 5. unwillingness to continuance 6. any change in disease treatment plan such as change in type and dose of lipid lowering drugs or surgical operation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Flow Mediated Dilatation (FMD) | 3 month | Change in dilatation of the brachial artery from baseline at 3 month |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| plasma lipid profile | 3 month | change in plasma level of lipid profile from baseline at 3 month |
| plasma level of high sensitive C reactive protein (hs-CRP) | 3 month | change in plasma level of high sensitive C reactive protein (hs-CRP) from baseline at 3 month |
| carotid intima-media thickness (c-IMT) | 3 month | change in carotid intima-media thickness from baseline at 3 month |
| asymmetric di-methyl arginine (ADMA) | 3 month | change in plasma level of assymetric di-methyl arginine from baseline at 3 month |
Other
| Measure | Time frame | Description |
|---|---|---|
| plasma levels of Tumor Necrosis Factor-alfa (TNF-a) | 3 month | change in plasma levels of TNF-a from baseline at 3 month |
| plasma levels of malondialdehyde (MDA) | 3 month | change in plasma levels of MDA from baseline at 3 month |
| plasma levels of Interleukine-6 (IL-6) | 3 month | change in plasma levels of IL-6 from baseline at 3 month |
Countries
Iran
Outcome results
None listed