Effects of Lutein Supplementation on Subclinical Atherosclerosis

Carotid Atherosclerosis Clinical Trial

Official title:

The Effects of Lutein Supplementation on Subclinical Atherosclerosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01534533
• Other study ID #: NNSFC-30972472
• Secondary ID: XLin
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: February 13, 2012
• Last updated: June 18, 2013
• Start date: June 2010
• Est. completion date: June 2012

Study information

• Verified date: June 2013
• Source: Peking University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: National Natural Science Foundation
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 192
• Est. completion date: June 2012
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 45 Years to 68 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Atherosclerosis
• Carotid Artery Diseases
• Carotid Atherosclerosis
• Carotid Intimal Medial Thickness 1

Intervention

Dietary Supplement:
• Placebo
one gelatine capsule containing starch per day, for 12 months
• Lutein group
one gelatine capsule containing 20mg lutein per day, for 12 months
• Combination group
one gelatine capsule containing 20mg lutein and 20 mg lycopene per day, for 12 months
• Normal lutein control group
subjects without early atherosclerosis, treated with one gelatine capsule containing 20mg lutein per day, for 12 months

Locations

Country	Name	City	State
China	Haidian District	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University

Country where clinical trial is conducted

China, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Table 1 Study Specific Characteristic Part One	The percentage of female, race, hypertenion history, diabetes history, and hyperlipemia history was calculated.	at baseline	No
Primary	Table 1 Study Specific Characteristic of Age	the mean and standard deviation of age was calculated in four groups	at baseline	No
Primary	Table 1 Study Specific Characteristic of Body Mass Index (BMI)	the mean and standard deviation of BMI in four groups was calculated	at baseline	No
Primary	Table 1 Study Specific Characteristic of Blood Pressure (BP)	systolic BP and diastolic BP in four groups was measure twice between 15minutes	at baseline	No
Primary	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	No
Secondary	Changes of Right Common Carotid Arterial Stiffness Parameter ß(R-ß) 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 a-10, Aloka Co. Ltd., Tokyo, Japan).	at baseline and after 12 months	No
Secondary	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	No
Secondary	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	No