Effects of Lutein and Zeaxanthin Upon MPOD and Its Effects Upon Glare Disability, Photostress Recovery, and Contrast Enhancement in Healthy Subjects: A Randomized, Double-blind Placebo-controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 109
- 试验地点
- 2
- 主要终点
- Macular Pigment Optical Density
研究概览
简要总结
The purpose of this study is:
I. To measure MP optical density (MPOD) in two groups (experimental and placebo) of 50 subjects each (N = 100), during an Lutein + Zeaxanthin supplementation period of 12 months.
II. To test the hypothesis that increases in MP (via 12 mg daily Lutein + Zeaxanthin supplementation) will result in significantly improved visual performance under disability glare conditions.
III. To test the hypothesis that increases in MP (via 12 mg daily L + Z supplementation) will result in significantly reduced photostress recovery times.
IV. To test the hypothesis that increases in MP (via 12 mg daily L + Z supplementation) will result in improved contrast enhancement.
详细描述
The following measurements will be taken, before and after supplementation with lutein and zeaxanthin:
Macular pigment optical density (MPOD) Visual performance under glare conditions Photostress recovery times chromatic contrast sensitivity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Gender: male or female
- •Age: 18 - 40 years
- •BMI: 20-30
- •No anticipated changes in dieting habits (as relevant to xanthophyll intake).
- •No anticipated surgical procedures.
- •Assessed as healthy, based on a pre-study examination including medical history, physical examination, and clinical laboratory. The examination will be performed by an MD or a Nurse Practitioner.
- •Willingness and ability to give written informed consent and willingness and ability to comply with the study requirements.
- •Corrected visual acuity (ETDRS): better than 20/60
排除标准
- •BMI <20 or >30
- •Age <18 or >40 years
- •Current or history of relevant diseases (such as AMD)
- •Corrected visual acuity worse than 20/60
- •Inability to reliably perform MPOD measurements by heterochromatic flicker photometry or any of the other ophthalmic tests of the study.
- •Any condition likely to interfere with normal gastro-intestinal absorption of xanthophylls.
- •Current use of xanthophyll containing supplements
- •Use of xanthophyll containing supplements in the past 6 months
- •Participation in any other study during last 1 month.
- •Blood donation during the last 3 months.
- •Known hypersensitivity or allergy to xanthophylls.
- •Regular intake of medications or supplements, which the principal investigator deems likely to confound the study outcomes.
- •Suspected lack of compliance with any requirements of the study.
- •Childbearing potential and unwillingness to refrain from acceptable anticonceptive measures (not including abstinence).
- •Current pregnancy or breast feeding
- •Any relevant abnormalities in the routine laboratory tests
结局指标
主要结局
Macular Pigment Optical Density
时间窗: every three months for one year; 12-month measure reported.
optical density of macular pigment layer of the neural retina at 30-minutes of retinal eccentricity
次要结局
- Photostress Recovery Time(improvement in recovery time; baseline recovery time (sec) minus 12-month recovery time (sec))
- Glare Disability(12-month data point only)
- Heterochromatic Contrast Sensitivity(12-month data point only)
研究者
Billy R. Hammond
Professor
University of Georgia