Clinical trial NCT01534533: Effects of Lutein Supplementation on Subclinical Atherosclerosis
Official title: The Effects of Lutein Supplementation on Subclinical Atherosclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Carotid Atherosclerosis
Carotid Intimal Medial Thickness 1
Keywords: early atherosclerosis
serum lutein
serum lycopene
intima-media thickness
arterial stiffness
combined effect
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2012-02-16
Enrollment: 192
Sex: ALL
Minimum age (years): 45
Maximum age (years): 68
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

* early atherosclerosis;
* aged 45 to 68 years;
* Han nationality

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

Primary outcomes:
measure: Table 1 Study Specific Characteristic Part One
timeFrame: at baseline
measure: Table 1 Study Specific Characteristic of Age
timeFrame: at baseline
measure: Table 1 Study Specific Characteristic of Body Mass Index (BMI)
timeFrame: at baseline
measure: Table 1 Study Specific Characteristic of Blood Pressure (BP)
timeFrame: at baseline
measure: Table 1 Study Specific Characteristic of Serum Carotenoids
timeFrame: at baseline
Secondary outcomes:
measure: Changes of Right Common Carotid Arterial Stiffness Parameter β(R-β) at Baseline and After 12 Months
timeFrame: at baseline and after 12 months
measure: Dietary Intake of Energy During the Study Periods
timeFrame: at baseline and 12 months
measure: Dietary Intake of Vitamin C,Vitamin E, Lutein Plus Zeaxanthin and Lycopene During the Study Periods
timeFrame: at baseline and 12 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Haidian District
Study officials:
affiliation: Peking University
name: Xiaoming Lin, M.M.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zou Z, Xu X, Huang Y, Xiao X, Ma L, Sun T, Dong P, Wang X, Lin X. High serum level of lutein may be protective against early atherosclerosis: the Beijing atherosclerosis study. Atherosclerosis. 2011 Dec;219(2):789-93. doi: 10.1016/j.atherosclerosis.2011.08.006. Epub 2011 Aug 10.