This study is to investigate the possible positive effects of lutein and lycopene supplementation on early atherosclerosis in Beijing.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
192
one gelatine capsule containing starch per day, for 12 months
one gelatine capsule containing 20mg lutein per day, for 12 months
one gelatine capsule containing 20mg lutein and 20 mg lycopene per day, for 12 months
Haidian District
Beijing, China
Table 1 Study Specific Characteristic Part One
The percentage of female, race, hypertenion history, diabetes history, and hyperlipemia history was calculated.
Time frame: at baseline
Table 1 Study Specific Characteristic of Age
the mean and standard deviation of age was calculated in four groups
Time frame: at baseline
Table 1 Study Specific Characteristic of Body Mass Index (BMI)
the mean and standard deviation of BMI in four groups was calculated
Time frame: at baseline
Table 1 Study Specific Characteristic of Blood Pressure (BP)
systolic BP and diastolic BP in four groups was measure twice between 15minutes
Time frame: at baseline
Table 1 Study Specific Characteristic of Serum Carotenoids
serum major carotenoids, including lutein, zeaxanthin, beta-carotene, and lycopene concentration were measured by hyper-pressure liquid chromatography (HPLC)
Time frame: at baseline
Changes of Right Common Carotid Arterial Stiffness Parameter β(R-β) at Baseline and After 12 Months
Arterial stiffness was measured by using a high-resolution B-mode carotid ultrasound with echo-tracking system (Aloka prosound α-10, Aloka Co. Ltd., Tokyo, Japan).
Time frame: at baseline and after 12 months
Dietary Intake of Energy During the Study Periods
Dietary intake was assessed at baseline and after 12months by using 3 consecutive 24-hour recalls.
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subjects without early atherosclerosis, treated with one gelatine capsule containing 20mg lutein per day, for 12 months
Time frame: at baseline and 12 months
Dietary Intake of Vitamin C,Vitamin E, Lutein Plus Zeaxanthin and Lycopene During the Study Periods
Dietary intake of Vitamin C,Vitamin E, Lutein plus zeaxanthin and Lycopene was assessed at baseline and after 12months by using 3 consecutive 24-hour recalls.
Time frame: at baseline and 12 months