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

September 6, 2018 updated by: Javad Nasrollahzadeh

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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]).

Study Type

Interventional

Enrollment (Actual)

87

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Flaxseed
Daily consumption of 30 grams flaxseed for 3 months
Other: Flaxseed
Daily consumption of 30 grams flaxseed in adjunct to medical treatment for 3 months
Active Comparator: Flaxseed and the Mediterranean-like diet
Daily consumption of 30 grams flaxseed in adjunct to the Mediterranean-like diet for 3 months
Other: Flaxseed
Daily consumption of 30 grams flaxseed in adjunct to medical treatment for 3 months
Other: the Mediterranean-like diet
Weekly Mediterranean-like diet menu in adjunct to medical treatment for 3 months
Placebo Comparator: Placebo
Daily consumption of Placebo for 3 months
Dietary supplement: Placebo
Daily consumption of one capsule of wheat fiber as placebo in adjunct to medical treatment for 3 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Flow Mediated Dilatation (FMD)
Time Frame: 3 month
Change in dilatation of the brachial artery from baseline at 3 month
3 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
plasma level of high sensitive C reactive protein (hs-CRP)
Time Frame: 3 month
change in plasma level of high sensitive C reactive protein (hs-CRP) from baseline at 3 month
3 month
plasma lipid profile
Time Frame: 3 month
change in plasma level of lipid profile from baseline at 3 month
3 month
carotid intima-media thickness (c-IMT)
Time Frame: 3 month
change in carotid intima-media thickness from baseline at 3 month
3 month
asymmetric di-methyl arginine (ADMA)
Time Frame: 3 month
change in plasma level of assymetric di-methyl arginine from baseline at 3 month
3 month

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
plasma levels of Interleukine-6 (IL-6)
Time Frame: 3 month
change in plasma levels of IL-6 from baseline at 3 month
3 month
plasma levels of malondialdehyde (MDA)
Time Frame: 3 month
change in plasma levels of MDA from baseline at 3 month
3 month
plasma levels of Tumor Necrosis Factor-alfa (TNF-a)
Time Frame: 3 month
change in plasma levels of TNF-a from baseline at 3 month
3 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Javad Nasrollahzadeh

Investigators

  • 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: 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
  • Principal Investigator: 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2017

Primary Completion (Actual)

May 1, 2018

Study Completion (Actual)

September 1, 2018

Study Registration Dates

First Submitted

December 7, 2017

First Submitted That Met QC Criteria

January 4, 2018

First Posted (Actual)

January 5, 2018

Study Record Updates

Last Update Posted (Actual)

September 7, 2018

Last Update Submitted That Met QC Criteria

September 6, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 651 (CHM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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