The Effect of a Healthy Diet Containing Flaxseed and Olive Oil on Cardiovascular Disease Risk Markers

Not Applicable

Completed

• Conditions: Coronary Artery Disease
• Interventions: Other: Dietary Intervention

• Registration Number: NCT04767230
• Lead Sponsor: Shahid Beheshti University of Medical Sciences

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 studied.The 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 mL/day 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 Timeline

• Study First Submitted: 2021-02-20
• Study First Submitted QC: 2021-02-20
• Study First Posted: 2021-02-23
• Study Start: 2021-03-01
• Primary Completion: 2021-08-30
• Status Verified: 2022-03
• Study Completion: 2022-03-03
• Last Update Submitted: 2022-03-03
• Last Update Posted: 2022-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Established coronary artery disease as verified by coronary angiography
2. Body ass index <30 kg/m2
3. men and postmenopausal women
4. Willing to participate in the study

Exclusion Criteria

1. Unwilling to follow the protocol and/or give informed consent
2. Chronic Kidney Disease stage 4 or 5 or a reported history cancer
3. Regular consumption of flaxseed or omega-3 supplements during previous month
4. Any changes in the disease treatment plan including type or dose of lipid-lowering medications or coronary artery bypass graft during the study period

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A heart-healthy diet + Flaxseed + Olive oil	Dietary Intervention	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 mL/day of refined olive oil (equivalent to 4 tablespoons; 2 tablespoons for lunch and 2 tablespoons for dinner) for 3 months
A heart-healthy diet	Dietary Intervention	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

Primary Outcome Measures

Name	Time	Method
Flow Mediated Dilation (FMD) in brachial artery	3 months	Measurement of dilation of the brachial artery by ultrasonography from baseline to 3 months later

Secondary Outcome Measures

Name	Time	Method
Total fatty acids composition of red blood cells	3 months	Measurement of total fatty acids composition of red blood cells by gas chromatography from baseline to 3 months later
Plasma lipid profile (total cholesterol, LDL-C, HDL-C, triglyceride)	3 months	Measurement of plasma level of lipid profile by enzymatic method from baseline to 3 months later

Trial Locations

Locations (1)

Shahid Beheshti University of Medical Sciences; 🇮🇷 Tehran, Iran, Islamic Republic of