Assessment of Optimal Egg Intake in a Healthy Population
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Plasma high-density lipoprotein (HDL)
研究概览
简要总结
Recently, the United States Department of Agriculture (USDA) has recommended removal of the 300mg/day limit on dietary cholesterol intake due to a lack of evidence supporting a connection between cholesterol intake and increased risk for cardiovascular disease (CVD). Previous work has shown that daily intake of eggs actually favorably alters many parameters associated with CVD risk. Conversely, emerging research suggests that choline, a nutrient in eggs, may be converted into trimethylamine oxide (TMAO) by the intestinal microbiota. TMAO is thought to increase the risk for CVD. Therefore, the purpose of this study is to determine a threshold of daily egg intake at which the risk for CVD is not negatively impacted in a young, healthy population.
详细描述
The purpose of this study is to establish a threshold of egg intake at which CVD risk is not negatively altered in young, healthy individuals. Participants (age 18-30, healthy lipid profile) will undergo a 2-week washout period followed by daily intake of 1, 2, and 3 eggs per day for 4 weeks each. Blood samples will be collected at baseline and following each 4-week dietary period. Samples will be analyzed to determine the impact of daily intake of increasing numbers of eggs on blood lipids, TMAO, biomarkers of oxidative stress and inflammation, and expression of cholesterol-related genes.
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 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI 18.5-29.9 kg/m2
- •Proficient in English
- •Cholesterol ≤ 240 mg/dL
- •Willing to consume 1, 2, and 3 eggs per day for 4 weeks each
排除标准
- •Diabetes mellitus, cardiovascular disease, history of stroke, renal disease, liver disease, cancer, or eating disorder
- •Taking glucose-lowering supplements or medications
- •Taking triglyceride-lowering medications, bile acid sequestrants, or high-dose chromium or cinnamon supplements
- •Plasma glucose < 126 mg/dL, triglycerides > 500 mg/dL, or blood pressure > 140/90 mmHg (average of 3 readings)
- •Allergy to eggs
结局指标
主要结局
Plasma high-density lipoprotein (HDL)
时间窗: 14 Weeks
Plasma HDL (in mg/dL) will be measured at 2, 6, 10, and 14 weeks to determine the impact of daily egg intake on HDL
次要结局
- Plasma trimethylamine oxide (TMAO)(14 Weeks)
研究者
Maria Luz Fernandez
Professor
University of Connecticut