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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

87 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-01

Study Completion Date

2018-09-01

Brief Summary

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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.

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Detailed Description

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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 \[TNF-a\]).

Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Flaxseed

Daily consumption of 30 grams flaxseed for 3 months

Group Type ACTIVE_COMPARATOR

Flaxseed

Intervention Type OTHER

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

Flaxseed and the Mediterranean-like diet

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

Group Type ACTIVE_COMPARATOR

Flaxseed

Intervention Type OTHER

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

the Mediterranean-like diet

Intervention Type OTHER

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

Placebo

Daily consumption of Placebo for 3 months

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Flaxseed

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

Intervention Type OTHER

the Mediterranean-like diet

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

Intervention Type OTHER

Placebo

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Javad Nasrollahzadeh

Director

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Javad Nasrollahzadeh, Ph.D

Role: STUDY_CHAIR

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

Javad Nasrollahzadeh, Ph.D

Role: STUDY_DIRECTOR

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

Nafiseh Khandouzi, Ph.D student

Role: PRINCIPAL_INVESTIGATOR

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