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临床试验/NCT02737293
NCT02737293终止不适用

Whole Egg Intake and the Mediterranean Diet

USDA Grand Forks Human Nutrition Research Center2 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2016年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
33
试验地点
2
主要终点
Change in lipoprotein metabolism

研究概览

简要总结

This project will evaluate the daily intake of whole eggs in the Mediterranean Diet (Med Diet). Cholesterol levels are normally related to cardiovascular disease (CVD) risk. Dietary fat and the total diet makeup are well known modifiers of CVD risk. The Med Diet has been shown to decrease blood lipids (fats) and reduce inflammation. Cholesterol intake from eggs may not be as bad as once thought and, in fact, may help to improve the blood lipid (fat) levels. This study is being done to test how the addition of eggs to a Med Diet affects blood lipids and other risk markers for CVD.

详细描述

Elevated serum cholesterol is a major contributor to cardiovascular disease (CVD), which is responsible for ~1/3 of all deaths in the US. However, about 50% of those who experience heart attacks have normal cholesterol levels. Cholesterol is carried in lipoproteins (HDL, LDL, and VLDL) and the amount in circulation is used to evaluate CVD risk. However, the particle size and density of lipoprotein subfractions may be more predictive for atherogenesis than their total levels. Dietary fatty acids are well recognized modulators of lipoproteins, and ultimately CVD risk. Saturated and trans fatty acids have a negative effect on CVD risk while poly- and monounsaturated fatty acids (PUFA, MUFA) appear to be protective. The Mediterranean Diet (Med Diet) decreases atherogenic lipoproteins and reduces systemic inflammation. It is unknown how high cholesterol intake within a Med Diet will affect these parameters, although recent evidence implies that the fatty acid content of the diet is more important than the cholesterol content. Therefore, this project will evaluate the daily inclusion of whole eggs, a high cholesterol food, in the Med Diet on lipid profiles, lipoprotein particle size and density and biomarkers of systemic inflammation.

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
20 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Willingness to comply with the demands of the experimental protocol
  • Not performing vigorous exercise >2 times per week
  • BMI 25-39.9 kg/m2
  • Non-nicotine-using

排除标准

  • Have an egg allergy
  • Have diabetes
  • Have high triglyceride levels
  • Have uncontrolled high blood pressure
  • Have used tobacco products or nicotine in any form including snuff, pills and patches, or e-cigarettes in the previous 6 months
  • Use prescription medications or over-the-counter lipid lowering drugs (such as statins) or anti-inflammatory medications (such as aspirin, ibuprofen or Aleve) on a regular basis
  • Take omega 3 supplements, plant sterols or sterol esters
  • Are pregnant or lactating
  • Have been diagnosed with an eating disorder
  • Inability to give consent
  • Unwillingness or inability to consume the treatment diets

结局指标

主要结局

Change in lipoprotein metabolism

时间窗: baseline and 4 weeks

Assess lipid metabolism response to the intervention.

次要结局

  • Change in inflammatory markers(baseline and 4 weeks)

研究者

发起方
USDA Grand Forks Human Nutrition Research Center
申办方类型
Fed
责任方
Sponsor

研究点 (2)

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