Acute Choline Supplementation and Cardiovascular Health in Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- Change in brachial artery function after supplementation
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 acute supplementation of dietary choline, which increases TMAO, impairs 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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18-65 years old
- •Non-smoking
- •Weight stable for previous 6 months (±2.0 kg)
- •BMI <35 kg/m^2
- •Verbal and written informed consent
- •Approved for participation by study medical director (Jose Rivero, M.D.)
排除标准
- •Pregnancy
- •Obese (BMI>35 kg/m2)
- •Altered dietary patterns within the last month of recruitment
- •Unstable heart disease or diabetes
- •Untreated high blood pressure or high cholesterol
- •Allergies to choline
- •Unvaccinated against COVID-19
结局指标
主要结局
Change in brachial artery function after supplementation
时间窗: 30-minute measurement in laboratory
Brachial artery function or flow mediated dilation (FMD), the blood flow and diameter of the brachial artery in the forearm (fMD), will be measured using a duplex ultrasound machine before and after the inflation of a blood pressure cuff on the forearm for 5 minutes and after placing a nitroglycerine tablet (0.4 mg) under the participant's tongue. This test will be conducted two times separated by about 1 week. The participant will be randomly-assigned to a supplement (choline or placebo) followed by a 1-week washout period (crossover design). The supplement will be taken with water between 10PM and 12AM the evening before the scheduled testing session. Off-line analysis of baseline and post-reactive hyperemic diameters and velocities will be performed using edge detection software (Vascular Analysis Tools, Medical Imaging Applications, Inc.).
次要结局
- Change in arterial stiffness after supplementation(45-minute measurement in laboratory)
研究者
Kevin Davy
Professor
Virginia Polytechnic Institute and State University