Flaxseed Consumption, Alone and in Combination With the Mediterranean-like Diet, on Some Indicators Related to Atherosclerosis

Coronary Artery Disease Clinical Trial

Official title:

Effects of Flaxseed Consumption, Alone and in Combination With the Mediterranean-like Diet, on Vascular Endothelial Function and Some Biochemical Indicators Related to Atherosclerosis in Patients With Coronary Artery Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03392025
• Other study ID #: 651
• Status: Completed
• Phase: N/A
• Start date: September 1, 2017
• Est. completion date: September 1, 2018

Study information

• Verified date: September 2018
• Source: Shahid Beheshti University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Flaxseed consumption has beneficial effects on cardiovascular risk factors. In addition, the benefit of the Mediterranean-like diet in primary and secondary prevention of cardiovascular diseases has been shown.The purpose of this study is to investigate the effects of flaxseed consumption, alone and in combination with the Mediterranean-like diet, in adjunct to conventional medical treatment, in improving vascular endothelial function, plasma lipid profile and high sensitivity c-reactive protein of coronary artery disease (CAD) patients.

Description:

A randomized placebo 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 81 eligible coronary artery disease patients, aged 20-75 years. Intervention groups will be received 30 g/d flaxseed, alone, or with weekly Mediterranean-like diet menu and control group will be received capsules of wheat fiber as placebo for 3 months. Vascular endothelial function will be evaluated through measurement of flow mediated dilatation (FMD) in brachial artery and carotid intima-media thickness (c-IMT) via ultrasound sonography and plasma level of asymmetric di-methyl arginine (ADMA). Fasting blood sample will be taken to measure malondialdehyde (MDA), lipid profile, high sensitive C-reactive protein and inflammatory cytokines (Interleukine-6 [IL-6] and Tumor Necrosis Factor-a [TNF-a]).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: September 1, 2018
• Est. primary completion date: May 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

Inclusion Criteria:

1. coronary artery disease patients (more than 50% blockage in coronary arteries) needed angioplasty with stent

2. willing to participation in the study

Exclusion Criteria:

1. cigarette Smoking

2. continuous consumption of any antioxidant supplement such as vitamin E, vitamin C and Selenium in last month

3. consumption of flaxseed or any omega-3 supplement at the beginning of the study

4. ?advanced renal disease

5. unwillingness to continuance

6. any change in disease treatment plan such as change in type and dose of lipid lowering drugs or surgical operation

Related Conditions & MeSH terms

• Atherosclerosis
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Other:
• Flaxseed
Daily consumption of 30 grams flaxseed in adjunct to medical treatment for 3 months
• the Mediterranean-like diet
Weekly Mediterranean-like diet menu in adjunct to medical treatment for 3 months

Dietary Supplement:
• Placebo
Daily consumption of one capsule of wheat fiber as placebo in adjunct to medical treatment for 3 months

Locations

Country	Name	City	State
Iran, Islamic Republic of	Rajaie Cardiovascular, Medical & Research Center	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Javad Nasrollahzadeh

Country where clinical trial is conducted

Iran, Islamic Republic of, 

References & Publications (8)

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. — View Citation

Cassani RS, Fassini PG, Silvah JH, Lima CM, Marchini JS. Retraction Note: Impact of weight loss diet associated with flaxseed on inflammatory markers in men with cardiovascular risk factors: a clinical study. Nutr J. 2016 Jun 7;15(1):59. — View Citation

Estruch R, Martínez-González MA, Corella D, Salas-Salvadó J, Ruiz-Gutiérrez V, Covas MI, Fiol M, Gómez-Gracia E, López-Sabater MC, Vinyoles E, Arós F, Conde M, Lahoz C, Lapetra J, Sáez G, Ros E; PREDIMED Study Investigators. Effects of a Mediterranean-style diet on cardiovascular risk factors: a randomized trial. Ann Intern Med. 2006 Jul 4;145(1):1-11. — View Citation

Fuentes F, López-Miranda J, Sánchez E, Sánchez F, Paez J, Paz-Rojas E, Marín C, Gómez P, Jimenez-Perepérez J, Ordovás JM, Pérez-Jiménez F. Mediterranean and low-fat diets improve endothelial function in hypercholesterolemic men. Ann Intern Med. 2001 Jun 19;134(12):1115-9. — View Citation

Marin C, Ramirez R, Delgado-Lista J, Yubero-Serrano EM, Perez-Martinez P, Carracedo J, Garcia-Rios A, Rodriguez F, Gutierrez-Mariscal FM, Gomez P, Perez-Jimenez F, Lopez-Miranda J. Mediterranean diet reduces endothelial damage and improves the regenerative capacity of endothelium. Am J Clin Nutr. 2011 Feb;93(2):267-74. doi: 10.3945/ajcn.110.006866. Epub 2010 Dec 1. — View Citation

Murie-Fernandez M, Irimia P, Toledo E, Martínez-Vila E, Buil-Cosiales P, Serrano-Martínez M, Ruiz-Gutiérrez V, Ros E, Estruch R, Martínez-González MÁ; PREDIMED Investigators. Carotid intima-media thickness changes with Mediterranean diet: a randomized trial (PREDIMED-Navarra). Atherosclerosis. 2011 Nov;219(1):158-62. doi: 10.1016/j.atherosclerosis.2011.06.050. Epub 2011 Jul 6. — View Citation

Ros E, Martínez-González MA, Estruch R, Salas-Salvadó J, Fitó M, Martínez JA, Corella D. Mediterranean diet and cardiovascular health: Teachings of the PREDIMED study. Adv Nutr. 2014 May 14;5(3):330S-6S. doi: 10.3945/an.113.005389. Print 2014 May. Review. — View Citation

Widmer RJ, Flammer AJ, Lerman LO, Lerman A. The Mediterranean diet, its components, and cardiovascular disease. Am J Med. 2015 Mar;128(3):229-38. doi: 10.1016/j.amjmed.2014.10.014. Epub 2014 Oct 15. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	plasma levels of Interleukine-6 (IL-6)	change in plasma levels of IL-6 from baseline at 3 month	3 month
Other	plasma levels of malondialdehyde (MDA)	change in plasma levels of MDA from baseline at 3 month	3 month
Other	plasma levels of Tumor Necrosis Factor-alfa (TNF-a)	change in plasma levels of TNF-a from baseline at 3 month	3 month
Primary	Flow Mediated Dilatation (FMD)	Change in dilatation of the brachial artery from baseline at 3 month	3 month
Secondary	plasma level of high sensitive C reactive protein (hs-CRP)	change in plasma level of high sensitive C reactive protein (hs-CRP) from baseline at 3 month	3 month
Secondary	plasma lipid profile	change in plasma level of lipid profile from baseline at 3 month	3 month
Secondary	carotid intima-media thickness (c-IMT)	change in carotid intima-media thickness from baseline at 3 month	3 month
Secondary	asymmetric di-methyl arginine (ADMA)	change in plasma level of assymetric di-methyl arginine from baseline at 3 month	3 month