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

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Dietary Intervention
Sponsored by
Shahid Beheshti University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Coronary Artery Disease

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Shahid Beheshti University of Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

A heart-healthy diet + Flaxseed + Olive oil

A heart-healthy diet

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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

Full Information

First Posted
February 20, 2021
Last Updated
March 3, 2022
Sponsor
Shahid Beheshti University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT04767230
Brief Title
The Effect of a Healthy Diet Containing Flaxseed and Olive Oil on Cardiovascular Disease Risk Markers
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
August 30, 2021 (Actual)
Study Completion Date
March 3, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shahid Beheshti University of Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A heart-healthy diet + Flaxseed + Olive oil
Arm Type
Active Comparator
Arm Description
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
Arm Title
A heart-healthy diet
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Dietary Intervention
Intervention Description
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
Primary Outcome Measure Information:
Title
Flow Mediated Dilation (FMD) in brachial artery
Description
Measurement of dilation of the brachial artery by ultrasonography from baseline to 3 months later
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Plasma lipid profile (total cholesterol, LDL-C, HDL-C, triglyceride)
Description
Measurement of plasma level of lipid profile by enzymatic method from baseline to 3 months later
Time Frame
3 months
Title
Total fatty acids composition of red blood cells
Description
Measurement of total fatty acids composition of red blood cells by gas chromatography from baseline to 3 months later
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Established coronary artery disease as verified by coronary angiography Body ass index <30 kg/m2 men and postmenopausal women Willing to participate in the study Exclusion Criteria: Unwilling to follow the protocol and/or give informed consent Chronic Kidney Disease stage 4 or 5 or a reported history cancer Regular consumption of flaxseed or omega-3 supplements during previous month Any changes in the disease treatment plan including type or dose of lipid-lowering medications or coronary artery bypass graft during the study period
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Javad Nasrollahzadeh, Ph.D
Organizational Affiliation
Shahid Beheshti University of Medical Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Shahid Beheshti University of Medical Sciences
City
Tehran
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25694068
Citation
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.
Results Reference
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PubMed Identifier
30127374
Citation
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.
Results Reference
background
PubMed Identifier
16607740
Citation
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.
Results Reference
background
PubMed Identifier
18460483
Citation
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.
Results Reference
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The Effect of a Healthy Diet Containing Flaxseed and Olive Oil on Cardiovascular Disease Risk Markers

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