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临床试验/NCT02942628
NCT02942628已完成不适用

Vegetarian Diet in Patients With Ischemic Heart Disease: An Open-label, Randomized, Prospective Crossover Study

Region Örebro County1 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2017年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
31
试验地点
1
主要终点
Change in oxidative stress evaluated by oxidized LDL cholesterol changes

研究概览

简要总结

Open label, 4 week randomized, cross-over study to compare the effect of a vegetarian diet to a conventional (meat containing) diet based on the Swedish average meat consumption on a range of parameters with prognostic importance for cardiovascular disease.The study will be conducted in patients diagnosed with ischemic heart disease. We hypothesize that patients will benefit from a vegetarian diet as assessed by multiple risk markers for this type of disease with a primary focus on changes in oxidized LDL cholesterol.

详细描述

Background

Cardiovascular disease is the leading cause of death globally. Ischemic heart disease (IHD) contributes the most to this statistic and since 1990 the global burden of IHD has increased. It is estimated that 50 000 Swedish patients are hospitalized every year due to IHD. The risk of developing IHD is to a large extent determined by the existence and state of several modifiable risk factors including dietary habits, smoking, hypertension, diabetes mellitus, hyperlipidemia, high apolipoprotein B/ apolipoprotein A1-ratio, abdominal obesity, physical inactivity, alcohol consumption and psychosocial factors. High levels of oxidative stress, oxidized LDL cholesterol and the microbial metabolite trimethylamine N-oxide TMAO have been suggested to be associated with development of IHD.

A plant-based (vegetarian) diet may provide cardiovascular health benefits through various mechanisms. Clinical studies suggest that a vegetarian diet has positive effects on low-density lipoprotein (LDL) cholesterol, oxidized LDL cholesterol, total cholesterol, triglycerides, apolipoprotein B, body mass index (BMI), inflammatory markers, blood pressure, arterial intima-media thickness, insulin sensitivity, glycated hemoglobin, (HbA1c) and fasting glucose levels. Through positive impacts on risk factors that a vegetarian diet is associated with a lowered incidence and mortality of IHD and an overall reduced mortality.

A weakness of several prior long-term controlled studies comparing vegetarian and meat-containing diets is the lack of well-defined control diets leading to study heterogeneity. For example, some of the subjects on meat-containing diets consume great quantities of red meat, others eat substantial amounts of processed meat products and some eat mostly white meat and fish complicating interpretation of outcome. In cross-sectional or observational cohort studies comparing long-term vegetarians to long-term omnivores, results may be influenced by other lifestyle choices besides the studied diet, such as smoking and exercise.Furthermore, the participants in many previous studies were often healthy volunteers and not patients with overt cardiovascular disease.

Purpose

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
None

入排标准

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

入选标准

  • Stable ischemic heart disease and previous percutaneous coronary intervention (PCI.
  • Under optimal medical treatment including aspirin and cholesterol lowering drugs (statins)

排除标准

  • PCI treatment during the last 30 days
  • Inability to provide informed consent
  • Already following a vegetarian or a vegan diet
  • Known vitamin B deficiency
  • Known food allergy
  • Previous obesity surgery or gastric bypass surgery
  • Life expectancy <1 year

结局指标

主要结局

Change in oxidative stress evaluated by oxidized LDL cholesterol changes

时间窗: 4 weeks

次要结局

  • Changes in cardiovascular risk profile according to the Framingham Risk Score(4 weeks)
  • Changes in biomarkers of inflammation(4 weeks)
  • Changes in TMAO levels in plasma(4 weeks)
  • Changes in biomarkers of lipid status(4 weeks)
  • Changes in HbA1c(4 weeks)
  • Changes in gut microbiota(4 weeks)

研究者

发起方
Region Örebro County
申办方类型
Other
责任方
Sponsor

研究点 (1)

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