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

Javad Nasrollahzadeh

Status: Completed

Conditions: Coronary Artery Disease

Treatments: Other: the Mediterranean-like diet; Other: Flaxseed; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03392025

651

Details and patient eligibility

About

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.

Full 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]).

Enrollment: 87 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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87 participants in 3 patient groups, including a placebo group

Flaxseed

Active Comparator group

Description:

Daily consumption of 30 grams flaxseed for 3 months

Treatment:

Other: Flaxseed

Flaxseed and the Mediterranean-like diet

Active Comparator group

Description:

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

Treatment:

Other: the Mediterranean-like diet

Other: Flaxseed

Placebo

Placebo Comparator group

Description:

Daily consumption of Placebo for 3 months

Treatment:

Dietary Supplement: Placebo