Effects of Lutein Supplementation on Subclinical Atherosclerosis

Peking University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Carotid Atherosclerosis; Carotid Intimal Medial Thickness 1

Treatments: Dietary Supplement: Lutein group; Dietary Supplement: Normal lutein control group; Dietary Supplement: Combination group; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01534533

XLin (Registry Identifier)

NNSFC-30972472

Details and patient eligibility

About

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

Full 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.

Enrollment: 192 patients

Sex: All

Ages: 45 to 68 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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192 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

early atherosclerosis cases, received starch in hard shell gelatine capsules, once a day

Treatment:

Dietary Supplement: Placebo

Lutein group

Experimental group

Description:

early atherosclerosis cases, received 20mg lutein, once a day

Treatment:

Dietary Supplement: Lutein group

Combination group

Experimental group

Description:

early atherosclerosis cases, received 20mg lutein plus 20mg lycopene, once a day

Treatment:

Dietary Supplement: Combination group

Normal lutein control group

Experimental group

Description:

20mg lutein for subjects free from atherosclerosis, once a day

Treatment:

Dietary Supplement: Normal lutein control group