Ignite Creation Date:
2024-05-06 @ 3:48 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04767230
Status:
COMPLETED
Last Update Posted:
2022-03-04
First Post:
2021-02-20
Brief Title:
The Effect of a Healthy Diet Containing Flaxseed and Olive Oil on Cardiovascular Disease Risk Markers
Sponsor:
Shahid Beheshti University of Medical Sciences
Organization:
Shahid Beheshti University of Medical Sciences
Study Overview
Official Title:
The Effect of a Healthy Diet Containing Flaxseed and Olive Oil Compared With Healthy Dietary Advice on Cardiovascular Disease Risk Markers in Patients With Coronary Artery Disease
Status:
COMPLETED
Status Verified Date:
2022-03
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 and olive oil consumption have beneficial effects on cardiovascular risk factors Nonetheless the effects of their simultaneous consumption have not yet been studiedThe purpose of this study is to investigate the effects of a healthy diet containing flaxseed and olive oil compared with healthy dietary advice on cardiovascular disease risk markers in patients with coronary artery disease CAD in improving flow-mediated dilation plasma lipid profile and fatty acids composition of red blood cells
Detailed Description:
A randomized 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 50 eligible coronary artery disease patients aged 30-75 years Intervention group will be received a heart-healthy diet with a specified number of food servings from different food groups including vegetables fruits grains dairy products meats daily consumption of 30 grams of flaxseed 25 mLday of refined olive oil equivalent to 4 tablespoons 2 tablespoons for lunch and 2 tablespoons for dinner and control group will be received recommendations for a heart-healthy diet such as those of the American Heart Association for 3 months These include eating at least 5 servings of vegetables and fruits daily reduction in the consumption of sources of saturated and trans fats by avoiding the consumption of high-fat red meats and replacing them with low-fat meat or with poultry and fish replacing low-fat dairy sources with regular or high-fat ones consumption of regular vegetable oils such as canola and sunflower reduction in salt consumption and reduction in the consumption of simple sugars for 3 months Flow mediated dilatation FMD in brachial artery via ultrasonography plasma levels of lipids and lipoproteins via enzymatic method and fatty acids composition of red blood cells via gas chromatography method were measured
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