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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2009 by Peking University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Xi’an Jiaotong University College of Medicine
Information provided by (Responsible Party):
Le MA, Xi'an Jiaotong University College of Medicine
ClinicalTrials.gov Identifier:
NCT01056094
First received: January 25, 2010
Last updated: June 21, 2012
Last verified: April 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Oxidative Stress in Healthy Subjects
 Drug: Lutein
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Lutein Supplementation on Oxidative Stress and Inflammation in Healthy Nonsmokers

Resource links provided by NLM:

MedlinePlus related topics: Antioxidants
Drug Information available for: Lutein
U.S. FDA Resources

Further study details as provided by Peking University:

Primary Outcome Measures:
  • Biomarkers of lipid, protein and DNA oxidative damage, marker of antioxidant capacity and antioxidant enzyme activities(GPx,SOD and CAT)in healthy subjects. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: April 2010
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 20mg Lutein
Dietary Supplement: 20mg Lutein; daily supplementation 12 week
 Drug: Lutein
Dietary Supplement: 20mg,10mg, 0mg Lutein; daily supplementation 12 week
Active Comparator: 10mg Lutein
Dietary Supplement: 10mg Lutein; daily supplementation 12 week
 Drug: Lutein
Dietary Supplement: 20mg,10mg, 0mg Lutein; daily supplementation 12 week
Placebo Comparator: 0mg Lutein
Dietary Supplement: 0mg Lutein; daily supplementation 12 week
 Drug: Lutein
Dietary Supplement: 20mg,10mg, 0mg Lutein; daily supplementation 12 week

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.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01056094

Contacts
Contact: le ma, MD male@mail.xjtu.edu.cn

Locations
China, Shaanxi
Xi'an Jiaotong University College of Medicine Recruiting
Xian, Shaanxi, China, 710061
Contact: Le MA, MD         male@mail.xjtu.edu.cn    
Sponsors and Collaborators
Peking University
Xi’an Jiaotong University College of Medicine
  More Information

No publications provided

Responsible Party: Le MA, Xi'an Jiaotong University College of Medicine
ClinicalTrials.gov Identifier: NCT01056094     History of Changes
Other Study ID Numbers: CNS-06094
Study First Received: January 25, 2010
Last Updated: June 21, 2012
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

Additional relevant MeSH terms:
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on May 16, 2013