Effects of Lutein Supplementation on Subclinical Atherosclerosis

The Effects of Lutein Supplementation on Subclinical Atherosclerosis

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

Study Overview

• Status: Completed
• Conditions: Carotid Atherosclerosis; Carotid Intimal Medial Thickness 1
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Lutein group; Dietary supplement: Combination group; Dietary supplement: Normal lutein control group

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.

• Study Type: Interventional
• Enrollment (Actual): 192
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100191
    • Haidian District

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Peking University
• Investigators: Principal Investigator: Xiaoming Lin, M.M., Peking University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (Actual): June 1, 2011
• Study Completion (Actual): June 1, 2012

Study Registration Dates

• First Submitted: February 13, 2012
• First Submitted That Met QC Criteria: February 15, 2012
• First Posted (Estimate): February 16, 2012

Study Record Updates

• Last Update Posted (Estimate): July 22, 2013
• Last Update Submitted That Met QC Criteria: June 18, 2013
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Keywords: arterial stiffness; intima-media thickness; early atherosclerosis; serum lutein; serum lycopene; combined effect
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Carotid Artery Diseases; Atherosclerosis
• Other Study ID Numbers: NNSFC-30972472; XLin (XLin)