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

Oxidative Stress in Healthy Subjects Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01056094
• Other study ID #: CNS-06094
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: January 25, 2010
• Last updated: June 21, 2012
• Start date: April 2010
• Est. completion date: August 2012

Study information

• Verified date: April 2009
• Source: Peking University
• Contact: le ma, MD
• Email: male[@]mail.xjtu.edu.cn
• Is FDA regulated: No
• Health authority: China:the Fundamental Research Funds for the Central Universities, The medical ethics committee of Xi'an Jiaotong University College of MedicineUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: August 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Oxidative Stress in Healthy Subjects

Intervention

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

Locations

Country	Name	City	State
China	Xi'an Jiaotong University College of Medicine	Xian	Shaanxi

Sponsors (2)

Lead Sponsor	Collaborator
Peking University	Xi’an Jiaotong University College of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes