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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2012-08-31

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.

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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.

Conditions

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Oxidative Stress in Healthy Subjects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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20mg Lutein

Dietary Supplement: 20mg Lutein; daily supplementation 12 week

Group Type ACTIVE_COMPARATOR

Lutein

Intervention Type DRUG

Dietary Supplement: 20mg,10mg, 0mg Lutein; daily supplementation 12 week

10mg Lutein

Dietary Supplement: 10mg Lutein; daily supplementation 12 week

Group Type ACTIVE_COMPARATOR

Lutein

Intervention Type DRUG

Dietary Supplement: 20mg,10mg, 0mg Lutein; daily supplementation 12 week

0mg Lutein

Dietary Supplement: 0mg Lutein; daily supplementation 12 week

Group Type PLACEBO_COMPARATOR

Lutein

Intervention Type DRUG

Dietary Supplement: 20mg,10mg, 0mg Lutein; daily supplementation 12 week

Interventions

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Lutein

Dietary Supplement: 20mg,10mg, 0mg Lutein; daily supplementation 12 week

Intervention Type DRUG

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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes