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

Peking University

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Oxidative Stress in Healthy Subjects

Treatments: Drug: Lutein

Study type: Interventional

Funder types: Other

Identifiers

NCT01056094

CNS-06094

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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30 participants in 3 patient groups, including a placebo group

20mg Lutein

Active Comparator group

Description:

Dietary Supplement: 20mg Lutein; daily supplementation 12 week

Treatment:

Drug: Lutein

10mg Lutein

Active Comparator group

Description:

Dietary Supplement: 10mg Lutein; daily supplementation 12 week

Treatment:

Drug: Lutein

0mg Lutein

Placebo Comparator group

Description:

Dietary Supplement: 0mg Lutein; daily supplementation 12 week

Treatment:

Drug: Lutein