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

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Flaxseed
the Mediterranean-like diet
Placebo
Sponsored by
Javad Nasrollahzadeh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Coronary Artery Disease

Eligibility Criteria

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

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

Sites / Locations

  • Rajaie Cardiovascular, Medical & Research Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Flaxseed

Flaxseed and the Mediterranean-like diet

Placebo

Arm Description

Daily consumption of 30 grams flaxseed for 3 months

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

Daily consumption of Placebo for 3 months

Outcomes

Primary Outcome Measures

Flow Mediated Dilatation (FMD)
Change in dilatation of the brachial artery from baseline at 3 month

Secondary Outcome Measures

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
plasma lipid profile
change in plasma level of lipid profile from baseline at 3 month
carotid intima-media thickness (c-IMT)
change in carotid intima-media thickness from baseline at 3 month
asymmetric di-methyl arginine (ADMA)
change in plasma level of assymetric di-methyl arginine from baseline at 3 month

Full Information

First Posted
December 7, 2017
Last Updated
September 6, 2018
Sponsor
Javad Nasrollahzadeh
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1. Study Identification

Unique Protocol Identification Number
NCT03392025
Brief Title
Flaxseed Consumption, Alone and in Combination With the Mediterranean-like Diet, on Some Indicators Related to Atherosclerosis
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
May 1, 2018 (Actual)
Study Completion Date
September 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Javad Nasrollahzadeh

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed 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]).

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
87 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Flaxseed
Arm Type
Active Comparator
Arm Description
Daily consumption of 30 grams flaxseed for 3 months
Arm Title
Flaxseed and the Mediterranean-like diet
Arm Type
Active Comparator
Arm Description
Daily consumption of 30 grams flaxseed in adjunct to the Mediterranean-like diet for 3 months
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Daily consumption of Placebo for 3 months
Intervention Type
Other
Intervention Name(s)
Flaxseed
Intervention Description
Daily consumption of 30 grams flaxseed in adjunct to medical treatment for 3 months
Intervention Type
Other
Intervention Name(s)
the Mediterranean-like diet
Intervention Description
Weekly Mediterranean-like diet menu in adjunct to medical treatment for 3 months
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Daily consumption of one capsule of wheat fiber as placebo in adjunct to medical treatment for 3 months
Primary Outcome Measure Information:
Title
Flow Mediated Dilatation (FMD)
Description
Change in dilatation of the brachial artery from baseline at 3 month
Time Frame
3 month
Secondary Outcome Measure Information:
Title
plasma level of high sensitive C reactive protein (hs-CRP)
Description
change in plasma level of high sensitive C reactive protein (hs-CRP) from baseline at 3 month
Time Frame
3 month
Title
plasma lipid profile
Description
change in plasma level of lipid profile from baseline at 3 month
Time Frame
3 month
Title
carotid intima-media thickness (c-IMT)
Description
change in carotid intima-media thickness from baseline at 3 month
Time Frame
3 month
Title
asymmetric di-methyl arginine (ADMA)
Description
change in plasma level of assymetric di-methyl arginine from baseline at 3 month
Time Frame
3 month
Other Pre-specified Outcome Measures:
Title
plasma levels of Interleukine-6 (IL-6)
Description
change in plasma levels of IL-6 from baseline at 3 month
Time Frame
3 month
Title
plasma levels of malondialdehyde (MDA)
Description
change in plasma levels of MDA from baseline at 3 month
Time Frame
3 month
Title
plasma levels of Tumor Necrosis Factor-alfa (TNF-a)
Description
change in plasma levels of TNF-a from baseline at 3 month
Time Frame
3 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: coronary artery disease patients (more than 50% blockage in coronary arteries) needed angioplasty with stent willing to participation in the study Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Javad Nasrollahzadeh, Ph.D
Organizational Affiliation
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
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Javad Nasrollahzadeh, Ph.D
Organizational Affiliation
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
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Nafiseh Khandouzi, Ph.D student
Organizational Affiliation
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
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rajaie Cardiovascular, Medical & Research Center
City
Tehran
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
27267967
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. doi: 10.1186/s12937-016-0165-x. No abstract available.
Results Reference
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PubMed Identifier
25447615
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.
Results Reference
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PubMed Identifier
24829485
Citation
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.
Results Reference
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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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PubMed Identifier
11412051
Citation
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.
Results Reference
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PubMed Identifier
16818923
Citation
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. Erratum In: Ann Intern Med. 2018 Aug 21;169(4):270-271.
Results Reference
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PubMed Identifier
21802081
Citation
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.
Results Reference
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Citation
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Results Reference
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Flaxseed Consumption, Alone and in Combination With the Mediterranean-like Diet, on Some Indicators Related to Atherosclerosis

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