Egg Effects on Atherogenic Dyslipidemia, Glucose Metabolism and Inflammation in Diabetic Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- glycosylated hemoglobin
研究概览
简要总结
There is concern in the literature regarding egg consumption in diabetic people. The investigators hypothesis is that compared to an oatmeal-based breakfast, an egg-based breakfast will not increase the risk for heart disease in diabetic people but it may reduce inflammation, in this population characterized by chronic low grade inflammation.
This is a cross-over study in which subjects will be randomly allocated to consume 1 egg per day for breakfast or a bowl of oatmeal with lactose-free milk for 5 weeks. After a 3 wk washout period, subjects will be allocated to the alternate treatment for additional 5 weeks.
Blood will be collected at baseline and at the end of each dietary period to measure plasma lipids, glucose, insulin, glycosylated hemoglobin and inflammatory markers.
详细描述
This study is conducted in diabetic patients who are given two distinct breakfasts: eggs and oatmeal in a crossover design. The investigators hypothesis is that eggs will not increase the risk for heart disease in this population when compared to oatmeal but they will more likely reduce inflammation due to the presence of the carotenoids, lutein and zeaxanthin that are highly available in eggs.
In this study, the investigators are evaluating three main things
- Atherogenic dyslipidemia by measuring plasma lipids and lipoprotein mean size and subfractions by nuclear magnetic resonance.
- Glucose metabolism by measuring plasma glucose, insulin, insulin resistance and glycosylated hemoglobin.
- Inflammation by measuring liver enzymes, C reactive protein, tumor necrosis factor-alpha, interleukin-6.
All these measurements were done 24 weeks after completion of the study All data will be presented 1 year after completion of the study
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diabetic subjects diagnosed by physician
- •male and female
- •35-65 years
- •Glycosylated hemoglobin < 9%
排除标准
- •taking ezetimibe
- •heart disease
- •renal problems
- •thyroid problems
研究组 & 干预措施
Egg, one a day, for breakfast
The intervention consists in feeding the subjects egg, one a day for breakfast during 5 weeks. At the end of the intervention, blood will be obtained to measure plasma lipids, glucose, insulin and inflammatory markers. All measurements will be finished 24 weeks after the intervention is finished. All data will be reported 1 year after completion of the study.
干预措施: Egg, one a day, for breakfast (Other)
Egg, one a day, for breakfast
The intervention consists in feeding the subjects egg, one a day for breakfast during 5 weeks. At the end of the intervention, blood will be obtained to measure plasma lipids, glucose, insulin and inflammatory markers. All measurements will be finished 24 weeks after the intervention is finished. All data will be reported 1 year after completion of the study.
干预措施: Oatmeal, one cup a day (Other)
Oatmeal, one cup a day
In this arm, subjects will consume oatmeal for a period of 5 weeks. Blood samples will be taken and different parameters will be measured including plasma lipids, glucose, insulin and inflammatory markers. All these measurements will be finished 24 weeks after completion of the study. All data will be reported 1 year after completion of the study.
干预措施: Egg, one a day, for breakfast (Other)
Oatmeal, one cup a day
In this arm, subjects will consume oatmeal for a period of 5 weeks. Blood samples will be taken and different parameters will be measured including plasma lipids, glucose, insulin and inflammatory markers. All these measurements will be finished 24 weeks after completion of the study. All data will be reported 1 year after completion of the study.
干预措施: Oatmeal, one cup a day (Other)
结局指标
主要结局
glycosylated hemoglobin
时间窗: Assessed at base line and at the end of 5 weeks after the consumption of eggs and at the end of 5 weeks after the consumption of oatmeal
Glycosylated hemoglobin had to be \< 9% as one of the inclusion criteria. This parameter was assessed after 5 weeks that the subjects consumed the egg and after 5 weeks after the subjects were consuming the oatmeal.
次要结局
- plasma LDL cholesterol(Measured at baseline and 5 weeks after the consuming the eggs and 5 weeks after consuming the oatmeal)