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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Oxidative Stress in Healthy Subjects

Intervention / Treatment
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* Drug: Lutein


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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. |  | 12 weeks |