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

NCT04767230 | Completed DMC

• 1 other identifier: 25672
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Plasma lipid profile (total cholesterol, LDL-C, HDL-C, triglyceride)

  3 months

• Total fatty acids composition of red blood cells

  3 months

Study Arms (2)

A heart-healthy diet + Flaxseed + Olive oil

ACTIVE COMPARATOR

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

PLACEBO COMPARATOR

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

Interventions

Dietary Intervention OTHER

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

A heart-healthy diet; A heart-healthy diet + Flaxseed + Olive oil

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shahid Beheshti University of Medical Sciences: lead

Study Sites (1)

Shahid Beheshti University of Medical Sciences

Tehran, Iran

Location

Related Publications (4)

• 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.

  PMID: 25694068 BACKGROUND

• 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.

  PMID: 30127374 BACKGROUND

• 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.

  PMID: 16607740 BACKGROUND

• 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.

  PMID: 18460483 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics

Study Officials

• Javad Nasrollahzadeh, Ph.D

  Shahid Beheshti University of Medical Sciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 20, 2021
• First Posted: February 23, 2021
• Study Start: March 1, 2021
• Primary Completion: August 30, 2021
• Study Completion: March 3, 2022
• Last Updated: March 4, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)