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

Primary Purpose

Oxidative Stress in Healthy Subjects

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Lutein
Sponsored by
Peking University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Oxidative Stress in Healthy Subjects

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Xi'an Jiaotong University College of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

20mg Lutein

10mg Lutein

0mg Lutein

Arm Description

Dietary Supplement: 20mg Lutein; daily supplementation 12 week

Dietary Supplement: 10mg Lutein; daily supplementation 12 week

Dietary Supplement: 0mg Lutein; daily supplementation 12 week

Outcomes

Primary Outcome Measures

Biomarkers of lipid, protein and DNA oxidative damage, marker of antioxidant capacity and antioxidant enzyme activities(GPx,SOD and CAT)in healthy subjects.

Secondary Outcome Measures

Full Information

First Posted
January 25, 2010
Last Updated
June 21, 2012
Sponsor
Peking University
Collaborators
Health Science Center of Xi'an Jiaotong University
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1. Study Identification

Unique Protocol Identification Number
NCT01056094
Brief Title
Effects of Lutein Supplementation on Oxidative Stress and Inflammation in Healthy Nonsmokers
Official Title
Effects of Lutein Supplementation on Oxidative Stress and Inflammation in Healthy Nonsmokers
Study Type
Interventional

2. Study Status

Record Verification Date
April 2009
Overall Recruitment Status
Unknown status
Study Start Date
April 2010 (undefined)
Primary Completion Date
July 2012 (Anticipated)
Study Completion Date
August 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University
Collaborators
Health Science Center of Xi'an Jiaotong University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oxidative Stress in Healthy Subjects

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
20mg Lutein
Arm Type
Active Comparator
Arm Description
Dietary Supplement: 20mg Lutein; daily supplementation 12 week
Arm Title
10mg Lutein
Arm Type
Active Comparator
Arm Description
Dietary Supplement: 10mg Lutein; daily supplementation 12 week
Arm Title
0mg Lutein
Arm Type
Placebo Comparator
Arm Description
Dietary Supplement: 0mg Lutein; daily supplementation 12 week
Intervention Type
Drug
Intervention Name(s)
Lutein
Intervention Description
Dietary Supplement: 20mg,10mg, 0mg Lutein; daily supplementation 12 week
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
le ma, MD
Email
male@mail.xjtu.edu.cn
Facility Information:
Facility Name
Xi'an Jiaotong University College of Medicine
City
Xian
State/Province
Shaanxi
ZIP/Postal Code
710061
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Le MA, MD
Email
male@mail.xjtu.edu.cn

12. IPD Sharing Statement

Learn more about this trial

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

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