Rajaie Cardiovascular, Medical & Research Center
Tehran, Iran
NCT Number: NCT03392025
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.
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Notify Me20 year–75 year
All sexes
Interventional
Not applicable
Tehran, Iran
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]).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Daily consumption of 30 grams flaxseed in adjunct to medical treatment for 3 months
Weekly Mediterranean-like diet menu in adjunct to medical treatment for 3 months
Daily consumption of one capsule of wheat fiber as placebo in adjunct to medical treatment for 3 months
Time frame: 3 month
Change in dilatation of the brachial artery from baseline at 3 month
Time frame: 3 month
change in plasma level of high sensitive C reactive protein (hs-CRP) from baseline at 3 month
Time frame: 3 month
change in plasma level of lipid profile from baseline at 3 month
Time frame: 3 month
change in carotid intima-media thickness from baseline at 3 month
Time frame: 3 month
change in plasma level of assymetric di-methyl arginine from baseline at 3 month
Time frame: 3 month
change in plasma levels of IL-6 from baseline at 3 month
Time frame: 3 month
change in plasma levels of MDA from baseline at 3 month
Time frame: 3 month
change in plasma levels of TNF-a from baseline at 3 month
Javad Nasrollahzadeh
Other
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
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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