The Effects of Lutein Supplementation on Subclinical Atherosclerosis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 192
- 试验地点
- 2
- 主要终点
- Table 1 Study Specific Characteristic Part One
研究概览
简要总结
This study is to investigate the possible positive effects of lutein and lycopene supplementation on early atherosclerosis in Beijing.
详细描述
Atherosclerosis is the primary cause of cardiovascular and cerebrovascular diseases, both of which are the top two causes of death in industrialized countries including China. Lutein was found to be protective against atherosclerosis in some case control studies. However, the intervention on atherosclerosis have not been reported. In the present study, 192 subjects were randomly assigned to four groups treated with different amounts of lutein. The investigators observe the changes of serum lutein concentration by hyper-pressure liquid chromatography (HPLC), and compare the differences of common carotid IMT and arterial stiffness by carotid ultrasonography before and after the intervention. Serum biochemistry indexes including cholesterol (CHO), triglyceride (TG), high density lipoprotein-cholesterol (HDL-C), low density lipoprotein-cholesterol (LDL-C) and glucose (Glu) were measured at 0, 7 and 12 months of treatment by auto-analyzer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 68 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •early atherosclerosis;
- •aged 45 to 68 years;
- •Han nationality
排除标准
- •history of myocardial infarction,
- •revascularization,
- •coronary by-pass operation,
- •local carotid IMT > 1300μm or supplemental vitamin and/or mineral use for ≥ 4 week before the start of the study
结局指标
主要结局
Table 1 Study Specific Characteristic Part One
时间窗: at baseline
The percentage of female, race, hypertenion history, diabetes history, and hyperlipemia history was calculated.
Table 1 Study Specific Characteristic of Age
时间窗: at baseline
the mean and standard deviation of age was calculated in four groups
Table 1 Study Specific Characteristic of Body Mass Index (BMI)
时间窗: at baseline
the mean and standard deviation of BMI in four groups was calculated
Table 1 Study Specific Characteristic of Blood Pressure (BP)
时间窗: at baseline
systolic BP and diastolic BP in four groups was measure twice between 15minutes
Table 1 Study Specific Characteristic of Serum Carotenoids
时间窗: at baseline
serum major carotenoids, including lutein, zeaxanthin, beta-carotene, and lycopene concentration were measured by hyper-pressure liquid chromatography (HPLC)
次要结局
- Changes of Right Common Carotid Arterial Stiffness Parameter β(R-β) at Baseline and After 12 Months(at baseline and after 12 months)
- Dietary Intake of Energy During the Study Periods(at baseline and 12 months)
- Dietary Intake of Vitamin C,Vitamin E, Lutein Plus Zeaxanthin and Lycopene During the Study Periods(at baseline and 12 months)
研究者
Xiaoming Lin
Professor
Peking University