Effects of Lutein Supplementation on Subclinical Atherosclerosis

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

Detailed Description
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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.

Official Title
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The Effects of Lutein Supplementation on Subclinical Atherosclerosis

Conditions
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Carotid Atherosclerosis, Carotid Intimal Medial Thickness 1

Intervention / Treatment
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* Dietary Supplement: Placebo
* Dietary Supplement: Lutein group
* Dietary Supplement: Combination group
* Dietary Supplement: Normal lutein control group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 68 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>early atherosclerosis cases, received starch in hard shell gelatine capsules, once a day | Dietary Supplement: Placebo<br>* one gelatine capsule containing starch per day, for 12 months<br>|
| Experimental: Lutein group<br>early atherosclerosis cases, received 20mg lutein, once a day | Dietary Supplement: Lutein group<br>* one gelatine capsule containing 20mg lutein per day, for 12 months<br>|
| Experimental: Combination group<br>early atherosclerosis cases, received 20mg lutein plus 20mg lycopene, once a day | Dietary Supplement: Combination group<br>* one gelatine capsule containing 20mg lutein and 20 mg lycopene per day, for 12 months<br>|
| Experimental: Normal lutein control group<br>20mg lutein for subjects free from atherosclerosis, once a day | Dietary Supplement: Normal lutein control group<br>* subjects without early atherosclerosis, treated with one gelatine capsule containing 20mg lutein per day, for 12 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Table 1 Study Specific Characteristic Part One | The percentage of female, race, hypertenion history, diabetes history, and hyperlipemia history was calculated. | at baseline | 
| Table 1 Study Specific Characteristic of Age | the mean and standard deviation of age was calculated in four groups | at baseline | 
| Table 1 Study Specific Characteristic of Body Mass Index (BMI) | the mean and standard deviation of BMI in four groups was calculated | at baseline | 
| Table 1 Study Specific Characteristic of Blood Pressure (BP) | systolic BP and diastolic BP in four groups was measure twice between 15minutes | 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) | at baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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. | 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. | at baseline and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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early atherosclerosis, serum lutein, serum lycopene, intima-media thickness, arterial stiffness, combined effect