NCT03392025

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 87 (actual)
• Sponsor: Javad Nasrollahzadeh · Academic / Other
• Sex: All
• Age: 20 Years – 75 Years
• Healthy volunteers: Not accepted

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 \[TNF-a\]).

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
OTHER	Flaxseed	Daily consumption of 30 grams flaxseed in adjunct to medical treatment for 3 months
OTHER	the Mediterranean-like diet	Weekly Mediterranean-like diet menu in adjunct to medical treatment for 3 months
DIETARY_SUPPLEMENT	Placebo	Daily consumption of one capsule of wheat fiber as placebo in adjunct to medical treatment for 3 months

Timeline

• Start date: 2017-09-01
• Primary completion: 2018-05-01
• Completion: 2018-09-01
• First posted: 2018-01-05
• Last updated: 2018-09-07

Locations

1 site across 1 country: Iran