Egg Effects on the Immunomodulatory Properties of HDL
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Fasted HDL-cholesterol
研究概览
简要总结
The purpose of this study is to investigate the effects of egg intake on markers of HDL function and immune inflammation in healthy adults.
详细描述
28 healthy men and women (age 18-35 years old) will be recruited to participate in a 16-week randomized crossover study. Upon enrollment, all subjects will enter a 4-week run-in egg-free period where they will refrain from consuming any egg-based foods (Period 1). Subjects will then enter the first intervention period, where they be randomly assigned to consume either 3 whole eggs/day or the equivalent amount of egg white-based egg substitute/day for 4 weeks (Period 2). Afterwards, subjects will enter a 4-week washout period where egg-based foods are restricted (Period 3), followed by a second intervention period, where they be assigned to the alternative whole egg- or egg white-based treatment for 4 weeks (Period 4). Subjects will come to the Department of Biology at Fairfield University every two weeks to check-in, and to pick up their egg products during the intervention periods. Subjects will be asked to maintain their normal diet and physical activity practices throughout all periods of the study. Subjects will complete 5-day dietary records and physical activity logs at the end of each study period.
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
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18-35 years old
- •Body mass index (BMI) < 30 kg/m2, or < 30% body fat for men and < 40% body fat for women
- •Willingness to consume eggs or egg whites on a daily basis during study periods
排除标准
- •< 18 years old; > 35 years old
- •BMI ≥ 30 kg/m2, or ≥ 30% body fat for men and ≥ 40% body fat for women
- •Self-reported history of diabetes mellitus, coronary heart disease, stroke, renal problems, liver disease, cancer, pregnancy or lactation, autoimmunity, chronic infections, or egg allergy
- •Taking lipid-lowering medications (e.g. statins, fibrates)
- •A preexisting medical condition or implanted medical device that prevents participation in bioelectrical impedance measurements of body composition
- •Clinical lipid and glucose values that are highly elevated, including fasting triglycerides levels higher than 500 mg/dL, fasting glucose higher than 126 mg/dL, and plasma total cholesterol greater than 240 mg/dL
结局指标
主要结局
Fasted HDL-cholesterol
时间窗: 16 weeks
Measurement of fasted plasma HDL-cholesterol levels (mg/dL) at the end of the run-in period, and two intervention arms.
次要结局
- Fasted HDL lipid composition(16 weeks)
- Cholesterol-accepting capacity of serum(16 weeks)
- Inflammatory potential of peripheral blood mononuclear cells(16 weeks)
研究者
Catherine Andersen
Associate Professor of Biology
Fairfield University