Ignite Creation Date:
2024-05-06 @ 10:57 AM
Last Modification Date:
2024-10-26 @ 12:37 PM
Study NCT ID:
NCT03392025
Status:
COMPLETED
Last Update Posted:
2018-09-07
First Post:
2017-12-07
Brief Title:
Flaxseed Consumption Alone and in Combination With the Mediterranean-like Diet on Some Indicators Related to Atherosclerosis
Sponsor:
Javad Nasrollahzadeh
Organization:
Shahid Beheshti University
Study Overview
Official Title:
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
Status Verified Date:
2018-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 shownThe 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 gd 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None