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

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

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Other: Dietary Intervention

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Tehran, Iran, Islamic Republic of
    • Shahid Beheshti University of Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: A heart-healthy diet + Flaxseed + Olive oil; 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	Other: Dietary Intervention; A heart-healthy diet + daily consumption of 30 grams of flaxseed + 25 mL/day of refined olive oil in adjunct to medical treatment for 3 months
Placebo Comparator: A heart-healthy diet; 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	Other: Dietary Intervention; A heart-healthy diet + daily consumption of 30 grams of flaxseed + 25 mL/day of refined olive oil in adjunct to medical treatment for 3 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Flow Mediated Dilation (FMD) in brachial artery	Measurement of dilation of the brachial artery by ultrasonography from baseline to 3 months later	3 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Shahid Beheshti University of Medical Sciences
• Investigators: Study Director: Javad Nasrollahzadeh, Ph.D, Shahid Beheshti University of Medical Sciences

Publications and helpful links

General Publications

• Bloedon LT, Balikai S, Chittams J, Cunnane SC, Berlin JA, Rader DJ, Szapary PO. Flaxseed and cardiovascular risk factors: results from a double blind, randomized, controlled clinical trial. J Am Coll Nutr. 2008 Feb;27(1):65-74. doi: 10.1080/07315724.2008.10719676.
• Edel AL, Rodriguez-Leyva D, Maddaford TG, Caligiuri SP, Austria JA, Weighell W, Guzman R, Aliani M, Pierce GN. Dietary flaxseed independently lowers circulating cholesterol and lowers it beyond the effects of cholesterol-lowering medications alone in patients with peripheral artery disease. J Nutr. 2015 Apr;145(4):749-57. doi: 10.3945/jn.114.204594. Epub 2015 Feb 18.
• Khandouzi N, Zahedmehr A, Mohammadzadeh A, Sanati HR, Nasrollahzadeh J. Effect of flaxseed consumption on flow-mediated dilation and inflammatory biomarkers in patients with coronary artery disease: a randomized controlled trial. Eur J Clin Nutr. 2019 Feb;73(2):258-265. doi: 10.1038/s41430-018-0268-x. Epub 2018 Aug 20.
• Mandasescu S, Mocanu V, Dascalita AM, Haliga R, Nestian I, Stitt PA, Luca V. Flaxseed supplementation in hyperlipidemic patients. Rev Med Chir Soc Med Nat Iasi. 2005 Jul-Sep;109(3):502-6.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Actual): August 30, 2021
• Study Completion (Actual): March 3, 2022

Study Registration Dates

• First Submitted: February 20, 2021
• First Submitted That Met QC Criteria: February 20, 2021
• First Posted (Actual): February 23, 2021

Study Record Updates

• Last Update Posted (Actual): March 4, 2022
• Last Update Submitted That Met QC Criteria: March 3, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Cardiovascular Diseases
• Other Study ID Numbers: 25672

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No