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

NCT01056094 | Unknown Phase 1 DMC

• 1 other identifier: CNS-06094
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Oxidative Stress in Healthy Subjects

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

20mg Lutein

ACTIVE COMPARATOR

Dietary Supplement: 20mg Lutein; daily supplementation 12 week

Drug: Lutein

10mg Lutein

ACTIVE COMPARATOR

Dietary Supplement: 10mg Lutein; daily supplementation 12 week

Drug: Lutein

0mg Lutein

PLACEBO COMPARATOR

Dietary Supplement: 0mg Lutein; daily supplementation 12 week

Drug: Lutein

Interventions

Lutein DRUG

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

0mg Lutein; 10mg Lutein; 20mg Lutein

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy adult subjects aged in the range of 20 to 80

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University: lead
• Xi'an Jiaotong University: collaborator

Study Sites (1)

Xi'an Jiaotong University College of Medicine

Xi'an, Shaanxi, 710061, China

RECRUITING

MeSH Terms

Interventions

Lutein

Intervention Hierarchy (Ancestors)

Xanthophylls; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Pigments, Biological; Biological Factors

Central Study Contacts

le ma, MD

CONTACT

male@mail.xjtu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Xi'an Jiaotong University College of Medicine

Study Record Dates

• First Submitted: January 25, 2010
• First Posted: January 26, 2010
• Study Start: April 1, 2010
• Primary Completion: July 1, 2012
• Study Completion: August 1, 2012
• Last Updated: June 25, 2012

Record last verified: 2009-04

Locations

CN (1)