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Completed

NCT Number: NCT03392025

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

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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Key information

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rajaie Cardiovascular, Medical & Research Center

Tehran, Iran

About this study

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]).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Flaxseed

Other

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

the Mediterranean-like diet

Other

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

Placebo

Dietary Supplement

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

Primary outcomes

  1. Flow Mediated Dilatation (FMD)

    Time frame: 3 month

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

Secondary outcomes

  1. 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

  2. plasma lipid profile

    Time frame: 3 month

    change in plasma level of lipid profile from baseline at 3 month

  3. carotid intima-media thickness (c-IMT)

    Time frame: 3 month

    change in carotid intima-media thickness from baseline at 3 month

  4. asymmetric di-methyl arginine (ADMA)

    Time frame: 3 month

    change in plasma level of assymetric di-methyl arginine from baseline at 3 month

Other outcomes

  1. plasma levels of Interleukine-6 (IL-6)

    Time frame: 3 month

    change in plasma levels of IL-6 from baseline at 3 month

  2. plasma levels of malondialdehyde (MDA)

    Time frame: 3 month

    change in plasma levels of MDA from baseline at 3 month

  3. 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

Sponsors and collaborators

Lead sponsor

Javad Nasrollahzadeh

Other

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jan 5, 2018
Registry last updated
Sep 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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