Flaxseed Consumption, Alone and in Combination With the Mediterranean-like Diet, on Some Indicators Related to Atherosclerosis
- Conditions
- Coronary Artery Disease
- Interventions
- Other: FlaxseedDietary Supplement: PlaceboOther: the Mediterranean-like diet
- Registration Number
- NCT03392025
- Lead Sponsor
- Javad Nasrollahzadeh
- 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 \[TNF-a\]).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 87
- coronary artery disease patients (more than 50% blockage in coronary arteries) needed angioplasty with stent
- willing to participation in the study
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Flaxseed and the Mediterranean-like diet the Mediterranean-like diet Daily consumption of 30 grams flaxseed in adjunct to the Mediterranean-like diet for 3 months Flaxseed Flaxseed Daily consumption of 30 grams flaxseed for 3 months Flaxseed and the Mediterranean-like diet Flaxseed Daily consumption of 30 grams flaxseed in adjunct to the Mediterranean-like diet for 3 months Placebo Placebo Daily consumption of Placebo for 3 months
- Primary Outcome Measures
Name Time Method Flow Mediated Dilatation (FMD) 3 month Change in dilatation of the brachial artery from baseline at 3 month
- Secondary Outcome Measures
Name Time Method 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
plasma lipid profile 3 month change in plasma level of lipid profile 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
Trial Locations
- Locations (1)
Rajaie Cardiovascular, Medical & Research Center
🇮🇷Tehran, Iran, Islamic Republic of