HDL Lipidomic, Proteomic and Functional Changes in Response to Whole Egg Consumption in Overweight and Obese Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change from baseline Apo A-1 concentration
研究概览
简要总结
The objective of this randomized, single blinded cross-over study is to investigate effects of daily egg versus yolk-free egg substitute consumption on High Density Lipoprotein (HDL) composition and function in a population of overweight and obese postmenopausal women.
详细描述
The investigators hypothesize that after 4 weeks of daily consumption of whole egg versus yolk-free egg will result in differences in the HDL composition and profile of lipids and proteins (lipidome and proteome), which will be associated with changes in HDL functionality. It is further hypothesized that it will be possible to discriminate between responders and non-responders to eggs in terms of increasing both apolipoprotein A-1 (ApoA-I) content in the plasma, corresponding with more protective HDL particles; and increasing HDL functionality (cholesterol efflux and anti-oxidant capacity).
Subjects will consume an egg free diet during study protocols, except for the egg meal provided by the study. The study is comprised of two 4-week feeding periods with a 4-week washout between testing periods. While on the study, subjects will consume the equivalent of two eggs for breakfast, either whole egg or yolk-free egg. Following a 2-week low-egg lead-in period, subjects will be randomly selected to start on either arm and cross over to the other arm after the 4-week washout period.
Measured results will be compared between the baseline and the 4-week end point for each arm. Additional comparisons may be made between 4-week endpoints.
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
- Single (Participant)
入排标准
- 年龄范围
- 45 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •45-70 years old
- •Overweight or obese (BMI 25-35 kg/m2)
- •Post-menopausal (confirmed by clinical hormone levels assessed at screening if within one year of last menses)
- •Plasma HDL cholesterol greater than or equal to 50 mg/dL.
排除标准
- •Documented chronic diseases including diabetes, thyroid disease, metabolic syndrome, cancer (active), or previous cardiovascular events
- •Having 3 or more traits of Metabolic Syndrome
- •Egg allergy or multiple food allergies or food intolerances that would significantly limit food intake
- •Current consumption more than 1 alcoholic drink/ day
- •Extreme dietary or exercise patterns
- •Recent weight fluctuations (greater than 10% in the last six months)
- •Taking prescription lipid medications or other supplements known to alter lipoprotein metabolism such as isoflavones, red yeast rice, or > 1 g of fish oil/day.
- •Taking exogenous hormones (i.e. hormone replacement therapy)
结局指标
主要结局
Change from baseline Apo A-1 concentration
时间窗: 4 weeks
The concentration of HDL Apo A-1 will be measured at baseline and after 4 weeks of whole egg, and after 4 weeks of yolk-free egg consumption, in randomized order.
次要结局
- Change from baseline HDL function(4 weeks)
- Change from baseline HDL composition(4 weeks)