Effects of Lutein Supplementation on Subclinical Atherosclerosis

Phase 2

Completed

Interventions: Dietary Supplement: Placebo
Dietary Supplement: Lutein group
Dietary Supplement: Combination group
Dietary Supplement: Normal lutein control group

Brief Summary: This study is to investigate the possible positive effects of lutein and lycopene supplementation on early atherosclerosis in Beijing.

Detailed Description: 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.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

history of myocardial infarction,
stroke,
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

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	early atherosclerosis cases, received starch in hard shell gelatine capsules, once a day
Lutein group	Lutein group	early atherosclerosis cases, received 20mg lutein, once a day
Combination group	Combination group	early atherosclerosis cases, received 20mg lutein plus 20mg lycopene, once a day
Normal lutein control group	Normal lutein control group	20mg lutein for subjects free from atherosclerosis, once a day

Primary Outcome Measures

Name	Time	Method
Table 1 Study Specific Characteristic Part One	at baseline	The percentage of female, race, hypertenion history, diabetes history, and hyperlipemia history was calculated.
Table 1 Study Specific Characteristic of Age	at baseline	the mean and standard deviation of age was calculated in four groups
Table 1 Study Specific Characteristic of Body Mass Index (BMI)	at baseline	the mean and standard deviation of BMI in four groups was calculated
Table 1 Study Specific Characteristic of Blood Pressure (BP)	at baseline	systolic BP and diastolic BP in four groups was measure twice between 15minutes
Table 1 Study Specific Characteristic of Serum Carotenoids	at baseline	serum major carotenoids, including lutein, zeaxanthin, beta-carotene, and lycopene concentration were measured by hyper-pressure liquid chromatography (HPLC)

Secondary Outcome Measures

Name	Time	Method
Changes of Right Common Carotid Arterial Stiffness Parameter β(R-β) at Baseline and After 12 Months	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).
Dietary Intake of Energy During the Study Periods	at baseline and 12 months	Dietary intake was assessed at baseline and after 12months by using 3 consecutive 24-hour recalls.
Dietary Intake of Vitamin C,Vitamin E, Lutein Plus Zeaxanthin and Lycopene During the Study Periods	at baseline and 12 months	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.