Clinical trial NCT03392025: 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
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Lead sponsor: Shahid Beheshti University
Sponsor class: OTHER
First posted: 2018-01-05
Enrollment: 87
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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 \[TNF-a\]).

Eligibility criteria: 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

Primary outcomes:
measure: Flow Mediated Dilatation (FMD)
timeFrame: 3 month
Secondary outcomes:
measure: plasma level of high sensitive C reactive protein (hs-CRP)
timeFrame: 3 month
measure: plasma lipid profile
timeFrame: 3 month
measure: carotid intima-media thickness (c-IMT)
timeFrame: 3 month
measure: asymmetric di-methyl arginine (ADMA)
timeFrame: 3 month
Other outcomes:
measure: plasma levels of Interleukine-6 (IL-6)
timeFrame: 3 month
measure: plasma levels of malondialdehyde (MDA)
timeFrame: 3 month
measure: plasma levels of Tumor Necrosis Factor-alfa (TNF-a)
timeFrame: 3 month
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Rajaie Cardiovascular, Medical & Research Center
Study officials:
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
name: Javad Nasrollahzadeh, Ph.D
role: STUDY_CHAIR
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
name: Javad Nasrollahzadeh, Ph.D
role: STUDY_DIRECTOR
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
name: Nafiseh Khandouzi, Ph.D student
role: PRINCIPAL_INVESTIGATOR
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