Effects of Lutein Supplementation on Subclinical Atherosclerosis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Xiaoming Lin, Peking University
ClinicalTrials.gov Identifier:
NCT01534533
First received: February 13, 2012
Last updated: June 18, 2013
Last verified: June 2013
  Purpose

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


Condition Intervention Phase
Carotid Atherosclerosis
Carotid Intimal Medial Thickness 1
Dietary Supplement: Placebo
Dietary Supplement: Lutein group
Dietary Supplement: Combination group
Dietary Supplement: Normal lutein control group
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effects of Lutein Supplementation on Subclinical Atherosclerosis

Resource links provided by NLM:


Further study details as provided by Peking University:

Primary Outcome Measures:
  • Table 1 Study Specific Characteristic Part One [ Time Frame: at baseline ] [ Designated as safety issue: No ]
    The percentage of female, race, hypertenion history, diabetes history, and hyperlipemia history was calculated.

  • Table 1 Study Specific Characteristic of Age [ Time Frame: at baseline ] [ Designated as safety issue: No ]
    the mean and standard deviation of age was calculated in four groups

  • Table 1 Study Specific Characteristic of Body Mass Index (BMI) [ Time Frame: at baseline ] [ Designated as safety issue: No ]
    the mean and standard deviation of BMI in four groups was calculated

  • Table 1 Study Specific Characteristic of Blood Pressure (BP) [ Time Frame: at baseline ] [ Designated as safety issue: No ]
    systolic BP and diastolic BP in four groups was measure twice between 15minutes

  • Table 1 Study Specific Characteristic of Serum Carotenoids [ Time Frame: at baseline ] [ Designated as safety issue: No ]
    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 [ Time Frame: at baseline and after 12 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: at baseline and 12 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: at baseline and 12 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 192
Study Start Date: June 2010
Study Completion Date: June 2012
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   45 Years to 68 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01534533

Locations
China
Haidian District
Beijing, China, 100191
Sponsors and Collaborators
Peking University
Investigators
Principal Investigator: Xiaoming Lin, M.M. Peking University
  More Information

Publications:
Responsible Party: Xiaoming Lin, Professor, Peking University
ClinicalTrials.gov Identifier: NCT01534533     History of Changes
Other Study ID Numbers: NNSFC-30972472, XLin
Study First Received: February 13, 2012
Results First Received: July 26, 2012
Last Updated: June 18, 2013
Health Authority: China: National Natural Science Foundation

Keywords provided by Peking University:
early atherosclerosis
serum lutein
serum lycopene
intima-media thickness
arterial stiffness
combined effect

Additional relevant MeSH terms:
Atherosclerosis
Carotid Artery Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Lycopene
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Radiation-Protective Agents
Anticarcinogenic Agents
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 16, 2014