A Double-Blind, Placebo-Controlled Trial on the Effects of Lutein and Zeaxanthin on Macular pigment optical density response, Photo stress Recovery, Glare Disability, and Contrast Sensitivity.
试验速览
- 阶段
- Phase 3 4
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- 2.Lutein and Zeaxanthin amount in the plasma concentration
研究概览
简要总结
Lutein (L) and zeaxanthin (Z) are two of the widely available carotenoids present in the normal diet of the human and responsible for the bright colors of numerous fruits and vegetables. [1]. R-isomer of Zeaxanthin majorly present in the macula of the retina, though small amounts of S-zeaxanthin isomer are also evident [1, 2]. Humans are unable to synthesize lutein and zeaxanthin isomers; thus, these nutrients are obtained from natural dietary sources or from supplementation [1]. These products can’t be synthesized by the human body but need to be absorbed from the human diet [2]. The activity of these supplements and their serum concentration vary from person to person [1]. The daily supplementation with L+Z was observed to have many clinical benefits including its increase in serum levels and MPOD, improvements in contrast sensitivity and recovery from photo stress [2]. The available clinical evidence needs to be confirmed with the long-term supplementation and its long-term effects. The present study was designed to assess the efficacy and safety of Lutein and Zeaxanthin over four months supplementation.
Macular pigments promote vision in a number of different ways. Blue light filtration lessens chromatic aberration, which can improve contrast sensitivity and visual field test acuity. The supplementation is observed to elevate the levels of anti-oxidant enzymes significantly by their strong anti-oxidant effect, may reduce the oxidative damage and minimize oxidative stress. This prevents damage to the photoreceptors and retinal pigment epithelial cells. The mechanisms responsible for the action of Lutein and Zeaxanthin by actively quenching singlet oxygen and associated free radicals in the retina, they can further reduce oxidation by filtering blue light to prevent the development of reactive oxygen species, particularly singlet oxygen, in the retina. Also includes prevention of phototoxic damage by absorbing solar radiation, reduction of oxidative stress by scavenging ROS, and antioxidant, antiangiogenic, antiinflammatory properties and naturally either help prevent or reduce the risk of progression of eye diseases like age related macular degeneration and cataracts.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Double Blind Double Dummy
入排标准
- 年龄范围
- 20.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects aged from 20 to 65 years old inclusive of 20 exclusive of 65
- •Subjects who have MPOD level between 0.2 to 0.4 and those without any severe eye diseases.
- •Corrected eyesight is higher than 20/60 during eyesight testing corrected visual acuity.
- •The subjects who have drusen corresponding to early AMD category 2 of AREDS.
- •Subjects with BMI from 20 to 35 kgm2 inclusive of 20 exclusive of 35
- •Subjects able to give written informed consent and willing and able to comply with the study requirements.
排除标准
- •Subjects who are allergic to the study drug known hypersensitivity to xanthophylls
- •The subjects taking Lutein Zeaxanthin Omega 3 Betacarotene Astaxanthin Anthocyanin multi-vitamins treatment with Retinal which is the form of Vitamin A-aldehyde and the products of Functional ingredients that may help to eye health such as Bilberry extract Haematococcus extract Zeaxanthin extract Lutein compound within the past 3 months.
- •Subject with current use of xanthophyll or history of using xanthophyll containing supplements within the past 6 months
- •Inability to reliably perform MPOD measurements by heterochromatic flicker photometry or any of the other ophthalmic tests of the study.
- •Subjects with the complete vision loss ophthalmic patients other than AMD macular atrophy retinal surgery retinal laser treatment a cloudy cataract or cornea
- •Subjects with myopia if more than 6 diopters
- •Subjects with hyperlipidemia greater than 6.2 mmol per L
- •Subjects with severe cerebrovascular disease cerebral infarction cerebral hemorrhage etc heart disease angina pectoris myocardial infarction heart failure arrhythmia in need of treatment lung disease chronic obstructive pulmonary disease etc within the last 6 months However those who are clinically stable may participate in the trial at the investigator discretion
- •Subjects who are taking hyperlipidemia control agents controlled diets and a hormone replacement
- •Any relevant abnormalities in the routine laboratory tests
- •Those with a psychologically significant medical history or current disease schizophrenia epilepsy anorexia bulimia etc or a history of alcohol or the other drug abuse
- •Subject who are pregnant lactating woman or planning to become pregnant.
- •Subjects who are deemed inappropriate to participate in this study by investigator AREDS category 2 Early AMD characterized by a combination of multiple small drusen a few intermediate drusen 63 to 124 microns in diameter or retinal pigment epithelium RP abnormalities.
结局指标
主要结局
2.Lutein and Zeaxanthin amount in the plasma concentration
时间窗: Day 1, Day 60, Day 120.
Primary Outcome:
时间窗: Day 1, Day 60, Day 120.
1. Change from baseline (Visit1) in macular pigment optical density (MPOD)
时间窗: Day 1, Day 60, Day 120.
次要结局
- Secondary Outcome:(1. Change in glare disability and discomfort from baseline)