Short Term Choline Supplementation and Cardiometabolic Health in Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Change From Baseline in Insulin Sensitivity at 4 Weeks
研究概览
简要总结
Trimethylamine-N-oxide (TMAO), a metabolite produced by gut microbial metabolism of dietary choline, has recently been causally linked to atherosclerosis in animal models and has been shown to be predictive of cardiovascular disease (CVD) risk in some but not all cohort studies. The relevance of observations in animals to humans is unclear and little information is available on the mechanisms linking TMAO to increased CVD risk. Vascular dysfunction plays a critical role in the initiation and progression of atherothrombotic disease. Whether TMAO impairs vascular function in humans is not known. The purpose of this study is to determine if short term supplementation of dietary choline, which increases TMAO, affects CVD risk factors, such as glucose homeostasis and vascular function.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18-79 years
- •Weight stable for previous 6 months (+2.0kg)
- •Sedentary to recreationally active (<30 min aerobic exercise <2x/wk)
- •No plans to gain/lose weight or change physical activity level
- •Verbal and written informed consent
- •Willing to be randomized to treatment order
- •Fully vaccinated against COVID-19
排除标准
- •BMI > 35 kg/m2
- •Pregnant or plans of becoming pregnant
- •Vegetarian or Vegan
- •Changed dietary patterns within the last month
- •Diabetes (or use of diabetes medications) or unstable heart disease
- •Untreated high blood pressure or high cholesterol
- •Health problems that mide it unsafe to participate
- •Taking medications, vitamins or supplements that could affect study outcomes (including but not limited to aspirin, antibiotics, prebiotics, and probiotics)
- •Known allergy, hypersensitivity, intolerance to choline supplement or its ingredients
- •Trimethylaminuria or "fish odor" syndrome
结局指标
主要结局
Change From Baseline in Insulin Sensitivity at 4 Weeks
时间窗: Calculated difference between the baseline and 4-week testing session for each intervention
Participants will complete a 2-hour glucose tolerance test at baseline, immediately following the first intervention, after a 2-week washout, and immediately following the second intervention. A catheter will be placed in one of the participant's arms. After a baseline blood draw to measure fasting levels of glucose, insulin, cholesterol and other factors, participants will drink a glucose beverage (75 g). Blood will be collected in small amounts (less than one half teaspoon) at eight timepoints over a 2-hour period. Insulin sensitivity will be calculated using Matsuda's index (a ratio with no units). This test will be conducted two times separated by about 4 weeks for each intervention (choline, placebo).
次要结局
- Change in 24-hour Area Under the Curve for Glucose Levels After Supplementation(Difference in 24-hour glucose levels during free living at baseline and 4 weeks)
研究者
Kevin Davy
Professor
Virginia Polytechnic Institute and State University