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

NCT03392025 | Completed

• 1 other identifier: 651
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• Flow Mediated Dilatation (FMD)

  Change in dilatation of the brachial artery from baseline at 3 month

  3 month

Secondary Outcomes (4)

• plasma level of high sensitive C reactive protein (hs-CRP)

  3 month

• plasma lipid profile

  3 month

• carotid intima-media thickness (c-IMT)

  3 month

• asymmetric di-methyl arginine (ADMA)

  3 month

Other Outcomes (3)

• plasma levels of Interleukine-6 (IL-6)

  3 month

• plasma levels of malondialdehyde (MDA)

  3 month

• plasma levels of Tumor Necrosis Factor-alfa (TNF-a)

  3 month

Study Arms (3)

Flaxseed

ACTIVE COMPARATOR

Daily consumption of 30 grams flaxseed for 3 months

Other: Flaxseed

Flaxseed and the Mediterranean-like diet

ACTIVE COMPARATOR

Daily consumption of 30 grams flaxseed in adjunct to the Mediterranean-like diet for 3 months

Other: Flaxseed; Other: the Mediterranean-like diet

Placebo

PLACEBO COMPARATOR

Daily consumption of Placebo for 3 months

Dietary Supplement: Placebo

Interventions

Flaxseed OTHER

Daily consumption of 30 grams flaxseed in adjunct to medical treatment for 3 months

Flaxseed; Flaxseed and the Mediterranean-like diet

the Mediterranean-like diet OTHER

Weekly Mediterranean-like diet menu in adjunct to medical treatment for 3 months

Flaxseed and the Mediterranean-like diet

Placebo DIETARY_SUPPLEMENT

Daily consumption of one capsule of wheat fiber as placebo in adjunct to medical treatment for 3 months

Placebo

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• coronary artery disease patients (more than 50% blockage in coronary arteries) needed angioplasty with stent
• willing to participation in the study

You may not qualify if:

• cigarette Smoking
• continuous consumption of any antioxidant supplement such as vitamin E, vitamin C and Selenium in last month
• consumption of flaxseed or any omega-3 supplement at the beginning of the study
• َadvanced renal disease
• unwillingness to continuance
• any change in disease treatment plan such as change in type and dose of lipid lowering drugs or surgical operation

Sponsors & Collaborators

• Javad Nasrollahzadeh: lead

Study Sites (1)

Rajaie Cardiovascular, Medical & Research Center

Tehran, Iran

Location

Related Publications (8)

• 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. doi: 10.1186/s12937-016-0165-x. No abstract available.

  PMID: 27267967 BACKGROUND

• 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.

  PMID: 25447615 BACKGROUND

• Ros E, Martinez-Gonzalez MA, Estruch R, Salas-Salvado J, Fito M, Martinez 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.

  PMID: 24829485 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

• Fuentes F, Lopez-Miranda J, Sanchez E, Sanchez F, Paez J, Paz-Rojas E, Marin C, Gomez P, Jimenez-Pereperez J, Ordovas JM, Perez-Jimenez F. Mediterranean and low-fat diets improve endothelial function in hypercholesterolemic men. Ann Intern Med. 2001 Jun 19;134(12):1115-9. doi: 10.7326/0003-4819-134-12-200106190-00011.

  PMID: 11412051 BACKGROUND

• Estruch R, Martinez-Gonzalez MA, Corella D, Salas-Salvado J, Ruiz-Gutierrez V, Covas MI, Fiol M, Gomez-Gracia E, Lopez-Sabater MC, Vinyoles E, Aros F, Conde M, Lahoz C, Lapetra J, Saez 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. doi: 10.7326/0003-4819-145-1-200607040-00004.

  PMID: 16818923 BACKGROUND

• Murie-Fernandez M, Irimia P, Toledo E, Martinez-Vila E, Buil-Cosiales P, Serrano-Martinez M, Ruiz-Gutierrez V, Ros E, Estruch R, Martinez-Gonzalez MA; 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.

  PMID: 21802081 BACKGROUND

• 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.

  PMID: 21123460 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Linseed Oil

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Fats, Unsaturated; Fats; Lipids; Plant Oils; Oils; Plant Preparations; Biological Products; Complex Mixtures

Study Officials

• Javad Nasrollahzadeh, Ph.D

  Department of Clinical Nutrition and Diet Therapy, National Nutrition and Food Technology Research Institute, Faculty of Nutrition Sciences and Food Technology, Shahid Beheshti University of Medical Sciences

  STUDY CHAIR

• Javad Nasrollahzadeh, Ph.D

  Department of Clinical Nutrition and Diet Therapy, National Nutrition and Food Technology Research Institute, Faculty of Nutrition Sciences and Food Technology, Shahid Beheshti University of Medical Sciences

  STUDY DIRECTOR

• Nafiseh Khandouzi, Ph.D student

  Department of Clinical Nutrition and Diet Therapy, National Nutrition and Food Technology Research Institute, Faculty of Nutrition Sciences and Food Technology, Shahid Beheshti University of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: December 7, 2017
• First Posted: January 5, 2018
• Study Start: September 1, 2017
• Primary Completion: May 1, 2018
• Study Completion: September 1, 2018
• Last Updated: September 7, 2018

Record last verified: 2018-09

Locations

IR (1)