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

Phase 1

• Conditions: Oxidative Stress in Healthy Subjects
• Interventions: Drug: Lutein

• Registration Number: NCT01056094
• Lead Sponsor: Peking University

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.

Study Timeline

• Status Verified: 2009-04
• Study First Submitted: 2010-01-25
• Study First Submitted QC: 2010-01-25
• Study First Posted: 2010-01-26
• Study Start: 2010-04
• Last Update Submitted: 2012-06-21
• Last Update Posted: 2012-06-25
• Primary Completion: 2012-07
• Study Completion: 2012-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
20mg Lutein	Lutein	Dietary Supplement: 20mg Lutein; daily supplementation 12 week
10mg Lutein	Lutein	Dietary Supplement: 10mg Lutein; daily supplementation 12 week
0mg Lutein	Lutein	Dietary Supplement: 0mg Lutein; daily supplementation 12 week

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Xi'an Jiaotong University College of Medicine; 🇨🇳 Xian, Shaanxi, China