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临床试验/NCT01056094
NCT01056094Unknown1 期

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

Peking University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2010年4月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
发起方
入组人数
30
试验地点
1
主要终点
Biomarkers of lipid, protein and DNA oxidative damage, marker of antioxidant capacity and antioxidant enzyme activities(GPx,SOD and CAT)in healthy subjects.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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.

研究组 & 干预措施

20mg Lutein

Active Comparator

Dietary Supplement: 20mg Lutein; daily supplementation 12 week

干预措施: Lutein (Drug)

10mg Lutein

Active Comparator

Dietary Supplement: 10mg Lutein; daily supplementation 12 week

干预措施: Lutein (Drug)

0mg Lutein

Placebo Comparator

Dietary Supplement: 0mg Lutein; daily supplementation 12 week

干预措施: Lutein (Drug)

结局指标

主要结局

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

时间窗: 12 weeks

次要结局

未报告次要终点

研究者

发起方
Peking University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Le MA

Xi'an Jiaotong University College of Medicine

Health Science Center of Xi'an Jiaotong University

研究点 (1)

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