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临床试验/NCT04767230
NCT04767230已完成不适用

The Effect of a Healthy Diet Containing Flaxseed and Olive Oil Compared With Healthy Dietary Advice on Cardiovascular Disease Risk Markers in Patients With Coronary Artery Disease

Shahid Beheshti University of Medical Sciences1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2021年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
1
主要终点
Flow Mediated Dilation (FMD) in brachial artery

研究概览

简要总结

Flaxseed and olive oil consumption have beneficial effects on cardiovascular risk factors. Nonetheless the effects of their simultaneous consumption have not yet been studied.The purpose of this study is to investigate the effects of a healthy diet containing flaxseed and olive oil compared with healthy dietary advice on cardiovascular disease risk markers in patients with coronary artery disease (CAD), in improving flow-mediated dilation, plasma lipid profile and fatty acids composition of red blood cells.

详细描述

A randomized 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 50 eligible coronary artery disease patients, aged 30-75 years. Intervention group will be received a heart-healthy diet with a specified number of food servings from different food groups (including vegetables, fruits, grains, dairy products, meats) + daily consumption of 30 grams of flaxseed + 25 mL/day of refined olive oil (equivalent to 4 tablespoons; 2 tablespoons for lunch and 2 tablespoons for dinner); and control group will be received recommendations for a heart-healthy diet, such as those of the American Heart Association for 3 months. These include eating at least 5 servings of vegetables and fruits daily, reduction in the consumption of sources of saturated and trans fats by avoiding the consumption of high-fat red meats and replacing them with low-fat meat or with poultry and fish, replacing low-fat dairy sources with regular or high-fat ones; consumption of regular vegetable oils such as canola and sunflower; reduction in salt consumption; and reduction in the consumption of simple sugars, for 3 months. Flow mediated dilatation (FMD) in brachial artery via ultrasonography, plasma levels of lipids and lipoproteins via enzymatic method, and fatty acids composition of red blood cells via gas chromatography method were measured.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
30 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Established coronary artery disease as verified by coronary angiography
  • Body ass index <30 kg/m2
  • men and postmenopausal women
  • Willing to participate in the study

排除标准

  • Unwilling to follow the protocol and/or give informed consent
  • Chronic Kidney Disease stage 4 or 5 or a reported history cancer
  • Regular consumption of flaxseed or omega-3 supplements during previous month
  • Any changes in the disease treatment plan including type or dose of lipid-lowering medications or coronary artery bypass graft during the study period

结局指标

主要结局

Flow Mediated Dilation (FMD) in brachial artery

时间窗: 3 months

Measurement of dilation of the brachial artery by ultrasonography from baseline to 3 months later

次要结局

  • Total fatty acids composition of red blood cells(3 months)
  • Plasma lipid profile (total cholesterol, LDL-C, HDL-C, triglyceride)(3 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nafiseh Khandouzi

Principal Investigator

Shahid Beheshti University of Medical Sciences

研究点 (1)

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