NCT01534533

Effects of Lutein Supplementation on Subclinical Atherosclerosis

The Effects of Lutein Supplementation on Subclinical Atherosclerosis

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 192 (actual)
• Sponsor: Peking University · Academic / Other
• Sex: All
• Age: 45 Years – 68 Years
• Healthy volunteers: Accepted

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.

Conditions

• Carotid Atherosclerosis
• Carotid Intimal Medial Thickness 1

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Placebo	one gelatine capsule containing starch per day, for 12 months
DIETARY_SUPPLEMENT	Lutein group	one gelatine capsule containing 20mg lutein per day, for 12 months
DIETARY_SUPPLEMENT	Combination group	one gelatine capsule containing 20mg lutein and 20 mg lycopene per day, for 12 months
DIETARY_SUPPLEMENT	Normal lutein control group	subjects without early atherosclerosis, treated with one gelatine capsule containing 20mg lutein per day, for 12 months

Timeline

• Start date: 2010-06-01
• Primary completion: 2011-06-01
• Completion: 2012-06-01
• First posted: 2012-02-16
• Last updated: 2013-07-22
• Results posted: 2012-10-15

Locations

1 site across 1 country: China