Effects of Lutein Supplementation on Subclinical Atherosclerosis

NCT01534533 | Completed Phase 2 Results DMC

• 2 other identifiers: NNSFC-30972472XLin
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Carotid Atherosclerosis; Carotid Intimal Medial Thickness 1

Keywords

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

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (3)

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

  at baseline and after 12 months

• Dietary Intake of Energy During the Study Periods

  at baseline and 12 months

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

  at baseline and 12 months

Study Arms (4)

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Lutein group

EXPERIMENTAL

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

Dietary Supplement: Lutein group

Combination group

EXPERIMENTAL

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

Dietary Supplement: Combination group

Normal lutein control group

EXPERIMENTAL

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

Dietary Supplement: Normal lutein control group

Interventions

Placebo DIETARY_SUPPLEMENT

one gelatine capsule containing starch per day, for 12 months

Placebo

Lutein group DIETARY_SUPPLEMENT

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

Lutein group

Combination group DIETARY_SUPPLEMENT

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

Combination group

Normal lutein control group DIETARY_SUPPLEMENT

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

Normal lutein control group

Eligibility Criteria

• Age: 45 Years - 68 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• early atherosclerosis;
• aged 45 to 68 years;
• Han nationality

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking University: lead

Study Sites (1)

Haidian District

Beijing, 100191, China

Location

Related 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.

  PMID: 21872250 BACKGROUND

MeSH Terms

Conditions

Carotid Artery Diseases; Carotid Intimal Medial Thickness 1; Atherosclerosis

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases

Results Point of Contact

• Title: Dr. Zhiyong Zou
• Organization: Peking University

harveyzou2002@bjmu.edu.cn

+8610-13581525193

Study Officials

• Xiaoming Lin, M.M.

  Peking University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 13, 2012
• First Posted: February 16, 2012
• Study Start: June 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2012
• Last Updated: July 22, 2013
• Results First Posted: October 15, 2012

Record last verified: 2013-06

Locations

CN (1)