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

About this trial
This is an interventional treatment trial for Oxidative Stress in Healthy Subjects
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.
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
NCT ID
NCT01056094
First Posted
January 25, 2010
Last Updated
June 21, 2012
Sponsor
Peking University
Collaborators
Health Science Center of Xi'an Jiaotong University
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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