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


Phase 1/Phase 2
20 Years
80 Years
Open (Enrolling)
Both
Oxidative Stress in Healthy Subjects

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Trial Information

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


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.


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.

Type of Study:

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

Outcome Measure:

Biomarkers of lipid, protein and DNA oxidative damage, marker of antioxidant capacity and antioxidant enzyme activities(GPx,SOD and CAT)in healthy subjects.

Outcome Time Frame:

12 weeks

Safety Issue:

Yes

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 ID:

CNS-06094

NCT ID:

NCT01056094

Start Date:

April 2010

Completion Date:

August 2012

Related Keywords:

  • Oxidative Stress in Healthy Subjects
  • Inflammation

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