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Completed

NCT Number: NCT01534533

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.

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Key information

Conditions

Carotid Atherosclerosis Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Brain Diseases Cardiovascular Diseases Carotid Artery Diseases Carotid Intimal Medial Thickness 1 Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

45 year–68 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Haidian District

Beijing, 100191, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Dietary Supplement

one gelatine capsule containing starch per day, for 12 months

Lutein group

Dietary Supplement

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

Combination group

Dietary Supplement

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

Normal lutein control group

Dietary Supplement

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

Primary outcomes

  1. Table 1 Study Specific Characteristic Part One

    Time frame: at baseline

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

  2. Table 1 Study Specific Characteristic of Age

    Time frame: at baseline

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

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

    Time frame: at baseline

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

  4. Table 1 Study Specific Characteristic of Blood Pressure (BP)

    Time frame: at baseline

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

  5. Table 1 Study Specific Characteristic of Serum Carotenoids

    Time frame: at baseline

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

Secondary outcomes

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

    Time frame: 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).

  2. Dietary Intake of Energy During the Study Periods

    Time frame: at baseline and 12 months

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

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

    Time frame: at baseline and 12 months

    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.

Sponsors and collaborators

Lead sponsor

Peking University

Other

Registry information

Official study title

The Effects of Lutein Supplementation on Subclinical Atherosclerosis

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
Feb 16, 2012
Registry last updated
Jul 22, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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