Plasma Lipids-dependent Vitamin E Metabolism During Dynamic Hyperlipidemia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- AUC (Area Under the Curve) of vitamin E plasma from hour 1 to hour 23 by cohort.
研究概览
简要总结
Background:
Obesity is known to lead to diseases such as diabetes and high cholesterol (or fats) in the blood (hyperlipidemia). But no one knows why. Researchers think that high levels of fat in the blood may block important nutrients, such as vitamin E, from reaching places they are needed in the body.
Objective:
To learn how high-fat meals affect levels of vitamin E in the blood.
Eligibility:
People aged 18 to 65 with high blood fat levels. Healthy volunteers are also needed.
Design:
Participants will have 3 or 4 clinic visits in 3 months. The last visit will require them to stay in the clinic for 2 nights.
Participants will be screened. They will have a physical exam and blood tests.
After this visit, all participants must stop taking any dietary supplements.
Those who use them must also stop taking any drugs to lower their blood sugar and blood fats. These participants will have an extra visit for blood tests after 60 days.
The next visit will include 2 imaging scans:
Magnetic resonance imaging (MRI) of the abdomen. This scan will check for fat in the liver.
Dual-energy X-ray absorptiometry (DEXA). This scan measures the levels of body fat.
On day 1 of the clinic stay, participants will have 2 set meals, with nothing but water after 10 pm.
On day 2, they will drink high-fat shakes at 8 am, noon, and 4 pm. They will have blood draws every hour for 17 hours, and then every 2 hours until 7 am. The blood will be taken from a tube inserted into a vein and left in place for the day.
On day 3, they will go home.
详细描述
Study Description:
A controlled interventional study of effects of postprandial hypertriglyceridemia from three consecutive high-fat vitamin E-stripped meals on the dynamics of plasma vitamin E concentrations in subjects with baseline normo- and hyperlipidemia, to explore the concept of vitamin E sequestration by fats in plasma.
Objectives:
Primary Objective: Compare effects of postprandial hypertriglyceridemia (PHTG) on plasma/lipoprotein vitamin E dynamics in subjects between baseline normo- and hyperlipidemia.
Secondary Objectives: Compare effects of postprandial hypertriglyceridemia (PHTG) on other fat-soluble vitamins (gamma-tocopherol, phylloquinone [K1]; menaquinone [K2]; 25-OH vitamin D; retinol [A]) and related vitamers (beta-carotene, lycopene lutein/zeaxanthin) between subjects with baseline normo- and hyperlipidemia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
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
- 否
入选标准
- •INCLUSION CRITERIA
- •Males and females between the ages of 18 to 65
- •BMI 18.5 - 26.9 kg/m^2
- •Subject understands the protocol and provides written, informed consent in addition to a willingness to comply with specified follow-up instructions and evaluations
- •Normotensive, not on medications for hypertension
- •Not on glucose-lowering or lipid-lowing medications
- •Screening labs with baseline HbA1c <5.7%, baseline fasting triglyceride < 150 mg/dL and LDL <100 mg/dL
- •Liver fat <2%
- •Males and females between the ages of 18 to 65
- •BMI >26 kg/m^2 and <36 kg/m^2
- •Subject understands the protocol and provides written, informed consent in addition to a willingness to comply with specified follow-up instructions and evaluations.
- •Screening labs with baseline HbA1c <= 7.5%, agree to be off or stop oral glucose-lowering medications (metformin), baseline fasting triglyceride < 500 mg/dL and LDL <190 mg/dL, agree to be off or stop oral lipid-lowing medications for 4-10 weeks prior to the inpatient visit.
- •Liver fat <2%
排除标准
- •For women: pregnancy or currently breastfeeding
- •Subjects <18-year-old. This age group has a broad spectrum of hormonal profiles, due to development and puberty, which significantly increases the heterogenicity of the study subjects.
- •Subjects >65-year-old. This age group has significantly increased risk of cardiovascular diseases. To minimize the risk from temporarily suspending lipid- and glucose-lowering medications and stress from serial blood draws, we exclude these individuals.
- •Heavy alcohol user (males with >2 drinks per day or >14 drinks per week; female with >1 drinks per day or >7 drinks per week)
- •Current smoker, or former smoker who quit smoking <15 years ago
- •Subjects with weight changes greater than 20% baseline body weight over the past 3 months
- •Subjects with lactose intolerance unwilling to take lactase
- •Subjects with type 1 diabetes
- •Subjects with hemoglobin <11 g/dL or hematocrit <33%
- •Subjects with abnormal liver function test results
- •Subjects with liver fat >= 2% on abdominal MRI
- •Subjects with a history of pancreatitis, diabetes ketoacidosis, hyperosmolar hyperglycemic state, advanced atherosclerosis, cardiovascular diseases, kidney diseases, or liver diseases
- •Subjects with fat malabsorption including: history of gastrointestinal surgery, pancreatic insufficiency, inflammatory bowel disease, celiac disease, moderate-to-severe irritable bowel syndrome, and pathologic mutations impacting lipoprotein metabolism
- •Subjects on glucocorticoids >1 week (not including topical glucocorticoids)
- •Subjects with HIV
- •Subjects with uncontrolled psychiatric and/or behavioral disorders
- •Subjects taking diabetes medications other than metformin
- •Anticipated surgery during the study period
- •Subjects with severe medication-resistant claustrophobia
- •Subjects who are unwilling to stop medications, vitamins and/or dietary supplements that investigators have requested to be held
- •Subjects participating in any other clinical study without informing investigators
- •Any other reason or clinical condition that the investigators judge would interfere with study participation and/or be unsafe for a participant or staff member
研究组 & 干预措施
Healthy subjects
Three consecutive high-fat vitamin E-stripped meals
干预措施: High fat liquid shake (Dietary Supplement)
Subjects with hyperlipidemia
Three consecutive high-fat vitamin E-stripped meals
干预措施: High fat liquid shake (Dietary Supplement)
结局指标
主要结局
AUC (Area Under the Curve) of vitamin E plasma from hour 1 to hour 23 by cohort.
时间窗: From hour 1 to hour 23
Compare the effects of postprandial hypertriglyceridemia on plasma vitamin E dynamics in subjects between baseline normo- and hyperlipidemia.
次要结局
- AUC of gamma-tocopherol, phylloquinone [K1]; menaquinone [K2]; 25-OH vitamin D; retinol [A] from hour 1 to hour 23 by cohort.(From hour 1 to hour 23)