Plasma TMAO and Choline Levels in Individuals With Metabolic Syndrome - Comparison Between Eggs and Choline Supplement Intake
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 4
- 主要终点
- Plasma lipids (total cholesterol, HDL cholesterol and triglycerides) in mg/dL
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 and compare it to daily choline supplement (choline bitartrate) for a dose of approximately 400 mg/day on plasma concentrations of high density lipoprotein cholesterol (HDL-c), trimethylamine N oxide (TMAO) and plasma choline. The goal is to determine if choline given as phosphatidyl choline (from eggs) will have a more beneficial effect on plasma choline and microbiota.
详细描述
Epidemiological data suggests that egg intake does not increase the risk for cardiovascular disease (CVD). In fact eggs are a good source of phosphatidyl choline (PC) and choline has a number of metabolic roles including lipid metabolism, membrane structure, liver health and a neurotransmitter. Recent reports that choline may be metabolized by the intestinal microbiota into TMAO, a compound that may increase the risk for heart disease. It is not clear how much egg contribute to TMAO formation in individuals with metabolic syndrome.
Therefore the objective of this study is to determine the impact of daily intake of 3 eggs versus a choline supplement on plasma TMAO and other biomarkers for CVD risk and also to assess if there are changes in microbiota with these interventions that might lead to the increases of TMAO in plasma.
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
- 35 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All genders
- •35-70 years
- •Metabolic syndrome (based on 3 out of 5 characteristics: waist circumference > 88 cm for women and > 102 cm for men, plasma triglycerides > 150 mg/dL, fasting glucose > 100 mg/dL, blood pressure > 135/85 and HDL < 40 mg/dL for men and < 50 mg/dL for women),
- •willing to consume 3 eggs per day for 4 weeks
- •willing to consume choline supplement (400 mg/day for 4 weeks)
排除标准
- •Self-reported diaberes, cardiovascular disease, history of stroke, liver disease or cancer
- •Taking glucose lowering medications
- •Taking antibiotics in the previous 1 month
- •Triglycerides > 500 mg/dL,
- •Cholesterol > 240 mg/dL,
- •blood pressure > 145/100 mm of Hg
- •Allergic to eggs or to choline
结局指标
主要结局
Plasma lipids (total cholesterol, HDL cholesterol and triglycerides) in mg/dL
时间窗: 1 year
They will be measured simultaneoulsy by use of an automated spectrophotometer
Plasma choline and TMAO (micromol/L)
时间窗: 1 year
They will be measured simultaneously by use of a mass spectrophotometer
次要结局
- Analysis of microbiota diversity (expressed as concentrations of different microorganisms.(1 year)
研究者
Maria Luz Fernandez
Principal Investigator
University of Connecticut