Assessment of TMAO Formation With Egg Intake Versus Choline Supplement in a Healthy Population
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Eggs of Egg Consumption on Plasma Biochemical Parameters
研究概览
简要总结
The objective of this study is to determine the effects of consuming either 3 eggs per day as compared to a daily choline supplement (choline bitartrate, 397.5 mg choline/day) on plasma concentrations of High Density Lipoprotein-cholesterol (HDL-C), trimethylamine N-oxide (TMAO), and other biomarkers of cardiovascular disease risk in young, healthy individuals. The goal is to determine if choline given as phosphatidylcholine (eggs) will lead to a different TMAO response when compared to choline in free supplemental form.
详细描述
Epidemiological data in short term studies, suggests that egg intake does not increase risk for cardiovascular disease (CVD). In fact, eggs are a great source of phospholipids (phosphatidylcholine) where choline has many metabolic roles, specially in lipid metabolism and cell membrane structure. Choline is present in the diet as free choline, which is absorbed in the small intestines, or choline esters, which is absorbed intact primarily through the lymphatic system. In addition, recent evidence suggests that the choline found in eggs may be metabolized by intestinal microbes into trimethylamine N-oxide (TMAO), a compound that may increase the risk for CVD. However, it is not known to what extent egg intake may contribute to plasma TMAO concentrations.
Therefore, the objective of this study is to determine the impacts of daily intake of 3 eggs versus a choline supplement on plasma TMAO as well as other biomarkers for CVD risk, with the goal of determining if the same amount of choline given as phosphatidylcholine from eggs will increase plasma choline levels without a concomitant increase in plasma TMAO, such that CVD risk is not negatively impacted.
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
- •Men and women (18-30 years), BMI 18.5 - 29.9 kg/m2, proficient in English, and willing to consume 3 eggs per day or 397.5 mg of choline supplement (1½ tablets/day) for 4 weeks each.
排除标准
- •Self-reported diabetes mellitus, cardiovascular disease, history of stroke, renal problems, liver disease, cancer, or a diagnosed eating disorder
- •Taking any glucose-lowering prescriptions or supplements, triglyceride-lowering medications, bile acid sequestrants, or high dose chromium or cinnamon supplements
- •Taken antibiotics in the previous 1 months, or if they are vegetarian or vegan
- •BMI ≤ 18.4 or ≥ 30 kg/m2, or extreme clinical values, such as plasma triglycerides > 500 mg/dL, plasma glucose > 126 mg/dL, plasma cholesterol > 240 mg/dL, plasma creatinine ≤ 0.5 or ≥ 0.9 mg/dL for females and ≤ 0.7 or ≥ 1.2 mg/dL for males, or blood pressure > 140/90 mm Hg (average of 3 readings)
- •Allergic to eggs or any component of the choline supplement
研究组 & 干预措施
Egg intake
Consumption of 3 eggs per day for breakfast, 4 weeks
干预措施: Eggs (Other)
Choline Supplement intake
Consumption of choline supplement, 1 1/2 tablet (395mg choline), with breakfast for 4 weeks
干预措施: Choline Supplement (Dietary Supplement)
结局指标
主要结局
Eggs of Egg Consumption on Plasma Biochemical Parameters
时间窗: 1 year
Using plasma form each participant, an automated spectrophotometer is able to analyze at once plasma lipids \[total colesterol, triglycerides, HDL (mg/dL)\], glucose (mg/dL), CRP (mg/dL, and liver enzymes \[alanine aminotransferase and aspartate aminotransferase (U/L)\].
次要结局
- Effects of Intervention on Gene Expression using RT-PCR(1 year)
研究者
Maria Luz Fernandez
Professor
University of Connecticut