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Effects of Lutein Supplementation on Subclinical Atherosclerosis

Primary Purpose

Carotid Atherosclerosis, Carotid Intimal Medial Thickness 1

Status

Completed

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Placebo

Lutein group

Combination group

Normal lutein control group

About this trial

This is an interventional prevention trial for Carotid Atherosclerosis focused on measuring early atherosclerosis, serum lutein, serum lycopene, intima-media thickness, arterial stiffness, combined effect

Eligibility Criteria

45 Years - 68 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

Haidian District

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Lutein group

Combination group

Normal lutein control group

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

Table 1 Study Specific Characteristic Part One

The percentage of female, race, hypertenion history, diabetes history, and hyperlipemia history was calculated.

Table 1 Study Specific Characteristic of Age

the mean and standard deviation of age was calculated in four groups

Table 1 Study Specific Characteristic of Body Mass Index (BMI)

the mean and standard deviation of BMI in four groups was calculated

Table 1 Study Specific Characteristic of Blood Pressure (BP)

systolic BP and diastolic BP in four groups was measure twice between 15minutes

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)

Secondary Outcome Measures

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).

Dietary Intake of Energy During the Study Periods

Dietary intake was assessed at baseline and after 12months by using 3 consecutive 24-hour recalls.

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.

Full Information

NCT ID

NCT01534533

First Posted

February 13, 2012

Last Updated

June 18, 2013

Sponsor

Peking University

1. Study Identification

Unique Protocol Identification Number

NCT01534533

Brief Title

Effects of Lutein Supplementation on Subclinical Atherosclerosis

Official Title

The Effects of Lutein Supplementation on Subclinical Atherosclerosis

Study Type

Interventional

2. Study Status

Record Verification Date

June 2013

Overall Recruitment Status

Completed

Study Start Date

June 2010 (undefined)

Primary Completion Date

June 2011 (Actual)

Study Completion Date

June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Peking University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Carotid Atherosclerosis, Carotid Intimal Medial Thickness 1

Keywords

early atherosclerosis, serum lutein, serum lycopene, intima-media thickness, arterial stiffness, combined effect

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

192 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Arm Title

Lutein group

Arm Type

Experimental

Arm Description

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

Arm Title

Combination group

Arm Type

Experimental

Arm Description

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

Arm Title

Normal lutein control group

Arm Type

Experimental

Arm Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo

Intervention Description

one gelatine capsule containing starch per day, for 12 months

Intervention Type

Dietary Supplement

Intervention Name(s)

Lutein group

Intervention Description

one gelatine capsule containing 20mg lutein per day, for 12 months

Intervention Type

Dietary Supplement

Intervention Name(s)

Combination group

Intervention Description

one gelatine capsule containing 20mg lutein and 20 mg lycopene per day, for 12 months

Intervention Type

Dietary Supplement

Intervention Name(s)

Normal lutein control group

Intervention Description

subjects without early atherosclerosis, treated with one gelatine capsule containing 20mg lutein per day, for 12 months

Primary Outcome Measure Information:

Title

Table 1 Study Specific Characteristic Part One

Description

The percentage of female, race, hypertenion history, diabetes history, and hyperlipemia history was calculated.

Time Frame

at baseline

Title

Table 1 Study Specific Characteristic of Age

Description

the mean and standard deviation of age was calculated in four groups

Time Frame

at baseline

Title

Table 1 Study Specific Characteristic of Body Mass Index (BMI)

Description

the mean and standard deviation of BMI in four groups was calculated

Time Frame

at baseline

Title

Table 1 Study Specific Characteristic of Blood Pressure (BP)

Description

systolic BP and diastolic BP in four groups was measure twice between 15minutes

Time Frame

at baseline

Title

Table 1 Study Specific Characteristic of Serum Carotenoids

Description

serum major carotenoids, including lutein, zeaxanthin, beta-carotene, and lycopene concentration were measured by hyper-pressure liquid chromatography (HPLC)

Time Frame

at baseline

Secondary Outcome Measure Information:

Title

Changes of Right Common Carotid Arterial Stiffness Parameter β(R-β) at Baseline and After 12 Months

Description

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).

Time Frame

at baseline and after 12 months

Title

Dietary Intake of Energy During the Study Periods

Description

Dietary intake was assessed at baseline and after 12months by using 3 consecutive 24-hour recalls.

Time Frame

at baseline and 12 months

Title

Dietary Intake of Vitamin C,Vitamin E, Lutein Plus Zeaxanthin and Lycopene During the Study Periods

Description

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.

Time Frame

at baseline and 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

45 Years

Maximum Age & Unit of Time

68 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Xiaoming Lin, M.M.

Organizational Affiliation

Peking University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Haidian District

City

Beijing

ZIP/Postal Code

100191

Country

China

12. IPD Sharing Statement

Citations:

PubMed Identifier

21872250

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.

Results Reference

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Effects of Lutein Supplementation on Subclinical Atherosclerosis

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