Effects of Lutein Supplementation on Oxidative Stress and Inflammation in Healthy Nonsmokers

June 21, 2012 updated by: Le MA, Peking University
Lutein is one of oxygenated carotenoids. Over the past few years, there has been increased interest in evaluating the effect of lutein for optimizing immune functions. A large number of epidemiological studies support the notion that a high intake of lutein is associated with a reduced risk of coronary heart disease and certain types of cancer. The biological mechanisms for the protective effects of this carotenoid, including powerful modulation of functions and antioxidant properties, are only partially known. Although several nutrients and phytochemicals have been shown to modulate immune functions in humans, few studies have investigated the role of lutein consumption. No information is available as to whether lutein supplementation could be protective against oxidative stress. Therefore, the objective of the present study was to examine the effect of consuming different doses of lutein on oxidative stress in healthy subjects.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Participants with a history of smoking, alcohol consumption, body mass index (BMI)≥30kg/m2, allergies, ocular diseases and participants taking vitamins or other food supplements containing lutein were excluded from the study.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shaanxi
      • Xian, Shaanxi, China, 710061
        • Recruiting
        • Xi'an Jiaotong University College of Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy adult subjects aged in the range of 20 to 80

Exclusion Criteria:

  • Participants with a history of smoking
  • Alcohol consumption
  • Body mass index (BMI)≥30kg/m2
  • Allergies
  • Ocular diseases or recent infections(within the last year) and participants taking vitamins or other food supplements containing lutein the previous 2 months.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 20mg Lutein
Dietary Supplement: 20mg Lutein; daily supplementation 12 week
Drug: Lutein
Dietary Supplement: 20mg,10mg, 0mg Lutein; daily supplementation 12 week
Active Comparator: 10mg Lutein
Dietary Supplement: 10mg Lutein; daily supplementation 12 week
Drug: Lutein
Dietary Supplement: 20mg,10mg, 0mg Lutein; daily supplementation 12 week
Placebo Comparator: 0mg Lutein
Dietary Supplement: 0mg Lutein; daily supplementation 12 week
Drug: Lutein
Dietary Supplement: 20mg,10mg, 0mg Lutein; daily supplementation 12 week

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Biomarkers of lipid, protein and DNA oxidative damage, marker of antioxidant capacity and antioxidant enzyme activities(GPx,SOD and CAT)in healthy subjects.
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University

Collaborators

Health Science Center of Xi'an Jiaotong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Anticipated)

July 1, 2012

Study Completion (Anticipated)

August 1, 2012

Study Registration Dates

First Submitted

January 25, 2010

First Submitted That Met QC Criteria

January 25, 2010

First Posted (Estimate)

January 26, 2010

Study Record Updates

Last Update Posted (Estimate)

June 25, 2012

Last Update Submitted That Met QC Criteria

June 21, 2012

Last Verified

April 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CNS-06094

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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